MiniMed 780G System
Device Facts
| Record ID | P160017S091 |
|---|---|
| Device Name | MiniMed 780G System |
| Applicant | Medtronic Minimed, Inc. |
| Product Code | OZP · Clinical Chemistry |
| Decision Date | Apr 21, 2023 |
| Decision | APPR |
| Device Class | Class 3 |
| Attributes | Therapeutic, Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| P160017S091 · Apr 21, 2023 | MiniMed 780G System | Medtronic Minimed, Inc. | CareLink Personal database | The sponsor used real-world data from the CareLink Personal database to evaluate the performance of the MiniMed 780G system with Guardian Sensor (3) and Guardian 4 sensor in a real-world setting, specifically looking at CGM-derived metrics, GMI, and time in Auto Mode. | Real-world performance; CareLink Personal database; Automated insulin delivery; Type 1 diabetes |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Real-World Performance of the MiniMed 780G System; Retrospective analysis of voluntarily uploaded data; Follow-up/Duration: Data collected from October 5, 2020, to December 11, 2020; Study Period: October 2020 - December 2020 | 128 individuals with type 1 diabetes; Sample Size: 128; Number of Sites: Not applicable | Baseline (before automatic basal and correction boluses) | Mean SG values, GMI, percentage of time spent in glycemic ranges, time spent in Auto mode |
| Real-World Performance of the MiniMed 780G System with Guardian 4 sensor; Retrospective analysis of voluntarily uploaded data; Follow-up/Duration: Data collected as of January 12, 2022; Study Period: Data collected as of January 12, 2022 | 3,662 individuals with type 1 diabetes; Sample Size: 3,662; Number of Sites: Not applicable | Not applicable for this study | Mean SG values, GMI, percentage of time spent in glycemic ranges, time spent in Auto mode |
Indications for Use
The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard (SG) technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
Device Story
Ambulatory, battery-operated micro-infusion pump; delivers basal/bolus insulin subcutaneously. Integrates with Guardian Sensor (3) or Guardian 4 CGM via BLE; receives interstitial glucose data every 5 minutes. Advanced Hybrid Closed Loop (AHCL) algorithm automatically adjusts basal insulin and delivers auto-correction boluses based on CGM values. Used by patients with type 1 diabetes; requires prescription. Patients/caregivers monitor via pump interface or mobile app. Output includes insulin delivery and glucose trends; aids in glycemic management. Benefits include improved time-in-range and reduced hyperglycemia; risks include DKA or severe hypoglycemia due to infusion failure or algorithm error.
Clinical Evidence
Evidence includes a pivotal multi-center, single-arm study (n=329) evaluating the AHCL algorithm in home settings for 90 days, and a performance study (n=308) for the Guardian 4 sensor. Results showed improved time-in-range (70-180 mg/dL) and reduced HbA1c (-0.5%) across pediatric and adult populations. No device-related DKA occurred. Guardian 4 sensor accuracy (MARD) was 10.6% (adults) and 11.6% (pediatrics). Real-world evidence (n=3,662) confirmed safety and performance consistency.
Technological Characteristics
Ambulatory micro-infusion pump (MMT-1884) with 3.0 mL reservoir capacity. Connectivity via Bluetooth Low Energy (BLE) for CGM and mobile app integration. Sensing principle: electrochemical glucose sensor (interstitial fluid). Software algorithm: Advanced Hybrid Closed Loop (AHCL) with automated basal adjustment and correction bolus logic. Sterilization: sterile, single-use sensors. Power: battery-operated pump and transmitter.
Indications for Use
Indicated for management of type 1 diabetes mellitus in persons 7 years of age and older requiring insulin. Contraindicated for users requiring <8 or >250 units of insulin per day, those unable to recognize pump alerts, or those unwilling to perform at least 4 blood glucose meter readings per day.
Regulatory Classification
Identification
An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Predicate Devices
- MiniMed 770G system (P160017/S076)
Reference Devices
- MiniMed 670G system (P160017)
- MiniMed 630G system
- Guardian Connect system
- MiniMed 530G system (P120010/S046)
Submission Summary (Full Text)
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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
# I. GENERAL INFORMATION
Device Generic Name: Automated Insulin Dosing System
Device Trade Name: MiniMed 780G System
Device Procode: OZP
Applicant's Name and Address: Medtronic MiniMed, Inc.
18000 Devonshire Street
Northridge, CA 91325
Date(s) of Panel Recommendation: None
Premarket Approval Application (PMA) Number: P160017/S091
Date of FDA Notice of Approval: 4/21/2023
The original PMA for the MiniMed 670G system (P160017) was approved on September 28, 2016, for use in persons ages 14 years and older. PMA Panel Track Supplement P160017/S017, approved on February 13, 2018, added the upper arm as an alternate insertion site for the Guardian Sensor (3). PMA Panel Track Supplement P160017/S031, approved on June 21, 2018, expanded the indication for pediatric patients 7 to 13 years of age. PMA Panel Track Supplement P160017/S076, approved on August 31, 2020, expanded the indications for the MiniMed 770G system to include pediatric patients down to 2 years old and changed the pump communication protocol to Bluetooth Low Energy (BLE).
The current Panel Track Supplement was submitted to introduce the MiniMed 780G System, which updates the pump control algorithm from the Hybrid Closed Loop (HCL) algorithm to the Advanced Hybrid Closed Loop (AHCL) algorithm and to add compatibility to the new Guardian 4 Continuous Glucose Monitor (CGM) as an alternative CGM component for the system.
# II. INDICATIONS FOR USE
The MiniMed 780G system is indicated for use with either the Guardian Sensor (3)/Guardian Link (3) Transmitter, or with the Guardian 4 sensor/Guardian 4 transmitter. Indications for use for the MiniMed 780G system are provided for each of the two system configurations separately:
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# **MiniMed 780G System for use with Guardian Sensor (3)/Guardian Link (3) Transmitter**
# *MiniMed 780G System*
The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard (SG) technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
The MiniMed 780G system consists of the following devices:
- MiniMed 780G insulin pump
- Guardian Link (3) transmitter
- Guardian Sensor (3)
- One-press serter
- Accu-Chek™ Guide Link blood glucose meter
- Accu-Chek™ Guide Test Strips
The system requires a prescription from a healthcare professional.
# *Guardian Sensor (3)*
The Guardian Sensor (3) is intended for use with the MiniMed 780G system, MiniMed 770G system, MiniMed 670G system, MiniMed 630G system, and Guardian Connect system to continuously monitor glucose levels in persons with diabetes.
The sensor is intended for single use and requires a prescription. The Guardian Sensor (3) is indicated for seven days of continuous use.
The Guardian Sensor (3) is not intended to be used directly to make therapy adjustments while the MiniMed 780G system is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian Sensor (3).
The Guardian Sensor (3) has been studied and is approved for use in the systems, insertion sites, and ages listed in the following table:
| System | Approved Age | Sensor Insertion Site |
| --- | --- | --- |
| MiniMed 780G system | 7- 13 14 and older | Abdomen and Buttocks Abdomen and Arm |
| MiniMed 770G system | 2-13 14 and older | Abdomen and Buttocks Abdomen and Arm |
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| System | Approved Age | Sensor Insertion Site |
| --- | --- | --- |
| MiniMed 670G system | 7-13 14 and older | Abdomen and Buttocks Abdomen and Arm |
| MiniMed 630G system | 14 and older | Abdomen and Arm |
| Guardian Connect system | 14 and older | Abdomen and Arm |
#### *One-press Serter*
The serter is used as an aid for inserting the sensor. It is indicated for single-patient use and it is not intended for multiple-patient use.
#### *Guardian Link (3) Transmitter*
The Guardian Link (3) Transmitter is intended for use with the MiniMed 780G system. The Guardian Link (3) Transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 780G insulin pump. The transmitter is intended for single-patient multi-use.
#### *Accu-Chek™ Guide Link Blood Glucose Monitoring System*
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is comprised of the Accu-Chek™ Guide Link meter and the Accu-Chek™ Guide test strips.
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended for *in-vitro* diagnostic single-patient use by people with diabetes.
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosing or screening for diabetes mellitus and not for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended to be used to wirelessly transmit glucose values to the MiniMed 780G system and MiniMed 770G system with Bluetooth wireless technology through the use of Bluetooth low energy communication.
### **MiniMed 780G System for use with Guardian 4 Sensor/Guardian 4 Transmitter**
#### *MiniMed 780G System*
The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the
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management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard (SG) technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
The MiniMed 780G system consists of the following devices:
- MiniMed 780G insulin pump
- Guardian 4 transmitter
- Guardian 4 sensor
- One-press serter
- Accu-Chek™ Guide Link blood glucose meter
- Accu-Chek™ Guide Test Strips
The system requires a prescription from a healthcare professional.
*Guardian 4 Sensor*
The Guardian 4 Sensor is intended for use with the MiniMed 780G system and the Guardian 4 transmitter to continuously monitor glucose levels for the management of diabetes.
The sensor is intended for single use and requires a prescription. The Guardian 4 sensor is indicated for up to seven days of continuous use.
The Guardian 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian 4 sensor.
The Guardian 4 sensor has been studied and is approved for use in the systems, insertion sites, and ages listed in the following table.
| System | Age | Sensor Insertion Site |
| --- | --- | --- |
| MiniMed 780G system | 7 years and older | Arm |
*One-press Serter*
The serter is used as an aid for inserting the sensor. It is indicated for single-patient use and it is not intended for multiple-patient use.
*Guardian 4 Transmitter*
The Guardian 4 transmitter is intended for use with the MiniMed 780G system and Guardian 4 sensor to monitor glucose levels for the management of diabetes.
*Accu-Chek™ Guide Link Blood Glucose Monitoring System*
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The Accu-Chek™ Guide Link Blood Glucose Monitoring system is comprised of the Accu-Chek™ Guide Link meter and the Accu-Chek Guide test strips.
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended for *in-vitro* diagnostic single-patient use by people with diabetes.
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosing or screening for diabetes mellitus and not for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Accu-Chek™ Guide Link Blood Glucose Monitoring System is intended to be used to wirelessly transmit glucose values to the MiniMed 780G system and MiniMed 770G system with Bluetooth wireless technology through the use of Bluetooth low energy communication.
### III. CONTRAINDICATIONS
#### MiniMed 780G System for use with Guardian Sensor (3)/Guardian Link (3) Transmitter
A prominent boxed warning is included in the labeling regarding use of the device by users with a total daily insulin dose of less than 8 units:
“Do not use the SmartGuard feature for people who require less than eight units or more than 250 units of total daily insulin per day. A total daily dose of at least eight units, but no more than 250 units, is required to use the SmartGuard feature.”
The following contraindications for this device are also described in the labeling:
- Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms.
- Do not use the serter to insert sensors other than the Guardian Sensor (3). Medtronic cannot guarantee the safety or efficacy of this product if used with other sensors.
- The reservoir is contraindicated for the infusion of blood or blood products.
- Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion.
- Infusion sets are not indicated for the infusion of blood or blood products.
- Insulin pump therapy is not recommended for those who are unwilling to perform at least four BG meter readings per day. As insulin pumps use rapid-acting insulin only, BG testing is required to help identify rapid glycemic
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deterioration due to insulin infusion occlusion, infusion site problems, insulin stability issues, user error, or a combination of these.
- Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.
# **MiniMed 780G System for use with Guardian 4 Sensor/Guardian 4 Transmitter**
A prominent boxed warning is included in the labeling regarding use of the device by users with a total daily insulin dose of less than 8 units:
“Do not use the SmartGuard feature for people who require less than eight units or more than 250 units of total daily insulin per day. A total daily dose of at least eight units, but no more than 250 units, is required to use the SmartGuard feature.”
The following contraindications for this device are also described in the labeling:
- Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms.
- Do not use the serter to insert sensors other than the Guardian 4 sensor. Medtronic cannot guarantee the safety or efficacy of this product if used with other sensors.
- The reservoir is contraindicated for the infusion of blood or blood products.
- Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) Infusion.
- Infusion sets are not indicated for the infusion of blood or blood products.
- Insulin pump therapy is not recommended for persons who are unwilling to perform BG meter readings.
- Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.
# **IV. WARNINGS AND PRECAUTIONS**
The warnings and precautions can be found in the MiniMed 780G system labeling.
# **V. DEVICE DESCRIPTION**
The MiniMed 780G system is similar to the MiniMed 770G system (approved under P160017/S076). The Hybrid Closed Loop algorithms approved under P160017 were modified to the Advanced Hybrid Closed Loop (AHCL) algorithms. The MiniMed 780G system includes the following additional features that were not part of the MiniMed 770G system:
- Auto Correction Bolus Feature – A new feature that delivers correction boluses automatically under specific conditions without any user input or acknowledgement.
- Adjustable Target Setpoints – The Auto Basal Rate can be adjusted to one of 3 target setpoints: 100 mg/dL, 110 mg/dL or 120 mg/dL.
- Finetuning of Safeguards – Incorporated to reduce Auto Mode exits.
- User Interface Enhancements – Several screens updated and redesigned to clarify messaging for completing pump tasks.
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The MiniMed 780G system is comprised of the following devices:
# **MiniMed 780G Pump (MMT-1884)**
The MiniMed 780G pump (model MMT-1884) is an ambulatory, battery-operated, rate-programmable micro-infusion pump designed to deliver insulin from a reservoir. The reservoir is driven by a motor to deliver pre-determined basal rate profiles and user-selected bolus amounts of insulin into the subcutaneous tissue through an infusion set.
The MiniMed 780G pump is offered in one model (MMT-1884). The pump houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The reservoir is attached to a tube that connects to the user's infusion site on their body. The pump is intended to deliver insulin through a diffusion mechanism. Model MMT-1884 is compatible with a 3.0 mL reservoir. The pump only displays blood glucose level units in mg/dL and this units setting cannot be reconfigured by the user.
In addition to insulin delivery, the MiniMed 780G pump is designed to receive and display real-time interstitial fluid glucose values from a compatible CGM. The pump is compatible with two CGMs: the Guardian Sensor (3) with Guardian Link (3) Transmitter, and the Guardian 4 sensor with Guardian 4 transmitter. When used in combination with a CGM, the transmitter sends sensor signals to the MiniMed 780G pump via a BLE wireless communication protocol every five minutes.
When using the 780G pump with the Guardian Sensor (3), a BG meter reading is required at least every 12 hours to calibrate the sensor for optimal sensor performance. When using the 780G pump with the Guardian 4 sensor, calibration is not required. However, the system is designed to use every BG meter reading either entered manually or received from a linked glucose meter to calibrate the sensor.
The 780G Pump can operate in Manual Mode or Auto Mode, and each mode includes various features and capabilities. These features and capabilities are described in detail in the MiniMed 780G system user guide. A summary of these features and capabilities is provided in Table 1 below.
Table 1: Summary of the Features of the MiniMed 780G System
| Mode | Description | When is it Active? | Will I receive Alerts? |
| --- | --- | --- | --- |
| Manual Mode: Insulin Infusion Pump | This mode is when the device is functioning as a pump that can deliver insulin, but the device does not have a sensor connected, is not in Auto Mode and the insulin suspend features are not turned on. | This is the default mode and the user does not have to specifically turn this mode on. | There are alerts if the pump has any issues with delivering insulin (e.g. suspended delivery) or low reservoir. |
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| Mode | Description | When is it Active? | Will I receive Alerts? |
| --- | --- | --- | --- |
| Manual Mode: Sensor Augmented Pump | This mode is when the device is functioning as a sensor and pump, but the device is not in Auto Mode and the insulin suspend features are not turned on. | The user has to be wearing a CGM that will be communicating to the pump in order to receive sensor glucose alerts. | There is a mandatory severe low alarm for the system used with each compatible CGM: 54 mg/dL Guardian Link (3) CGM; 64 mg/dL Guardian 4 CGM. The user can also set optional high and low alerts to sound on or before set sensor glucose levels. |
| Manual Mode: Suspend On Low | When this feature is active the device detects that your sensor glucose level has reached a pre-set sensor glucose value and it automatically suspends basal insulin delivery when that value is reached. | The user has to turn this feature on. It is not available when Auto Mode is turned on, and it cannot be turned on if Suspend before Low is turned on. | There is a mandatory severe low alarm for the system used with each compatible CGM: 54 mg/dL for the Guardian Link (3) CGM; or 64 mg/dL for the Guardian 4 CGM, and at the pre-set low level. The user can also set optional high alerts to sound on or before set sensor glucose levels, and an optional alert before low alert. |
| Manual Mode: Suspend Before Low | When this feature is active the device detects when your sensor glucose is predicted to reach a pre-set value and it automatically suspends basal insulin delivery before that value is reached. | The user has to turn this feature on. It is not available when Auto Mode is turned on, and it cannot be turned on if Suspend On Low is turned on. | There is a mandatory severe low alarm for the system used with each compatible CGM: 54 mg/dL for the Guardian Link (3) CGM; or 64 mg/dL for the Guardian 4 CGM, and at the pre-set low level. The user can also set optional high alerts to sound on or before set sensor glucose levels, and an optional alarm before low alert. |
| Auto Mode | When this mode is active, the device can automatically adjust basal insulin by increasing, decreasing, or turning off basal insulin delivery based on sensor glucose levels. The device can also automatically deliver an auto correction bolus without the user input based on the sensor glucose levels. | The user has to turn this mode on and certain pre-defined conditions have to be met. | There is a mandatory severe low alarm for the system used with each compatible CGM: 54 mg/dL for the Guardian Link (3) CGM; or 64 mg/dL for the Guardian 4 CGM, and a mandatory high alarm if user is ≥250 mg/dL for 3 hours; The user can also set optional high and low alerts to sound on or before set sensor glucose levels. |
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| Mode | Description | When is it Active? | Will I receive Alerts? |
| --- | --- | --- | --- |
| Auto Mode: Safe Basal Delivery | When this feature is active, the device will deliver basal insulin at a patient-specific safe basal or safe basal low rate for no longer than 90 minutes. If the fault condition resolves within 90 minutes, the system will begin to automatically adjust basal insulin again. If the fault does not resolve within 90 minutes, the system will switch to Manual Mode. | This feature turns on when the system determines that either the sensor data is not adequate for Auto Mode or delivery at the minimum or maximum limit for a set amount of time has elapsed. | There is a mandatory alert before this feature turns on when the sensor glucose accuracy check fails. The user can also set optional alerts to sound before this feature turns on when minimum or maximum insulin delivery times out or when the sensor has been under- reading for too long. There is a mandatory severe low alarm for the system used with each compatible CGM: 54 mg/dL for the Guardian Link (3) CGM; or 64 mg/dL for the Guardian 4 CGM. The user can also set optional high and low alerts to sound on or before set sensor glucose levels. |
### **Guardian Link (3) Transmitter (MMT-7911)**
The Guardian Link (3) Transmitter is a portable, electrical current meter intended to process, store, and transmit glucose sensor values to the compatible insulin pump. The transmitter sends sensor glucose (SG) values and sensor integrity (SI) data from the Guardian Sensor (3) to the compatible insulin pumps via BLE wireless communication protocol. The transmitter was previously reviewed and approved under P160017/S076.
### **Guardian Sensor (3) (MMT-7020)**
The Guardian Sensor (3) is a sterile, single-use, single patient glucose sensing component for continuous monitoring of glucose levels in the user's interstitial fluid for up to seven days. The Sensor is inserted into the subcutaneous tissue using the One-Press Serter and is taped to the user's skin. It connects to the Guardian Link (3) Transmitter, which in turn communicates with the MiniMed 780G Pump.
When making treatment decisions, such as determining insulin dose for meals, the MiniMed 780G with Guardian Sensor (3) continuous glucose monitor (CGM) values should not be used, as the CGM is not intended to be used to make such treatment decisions. The Guardian Sensor (3) is not intended to replace a blood glucose meter. Users should always use the values from a blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose values. Using the sensor glucose readings for treatment decisions could lead to unwanted high or low blood glucose. When using the 780G pump with the Guardian Sensor (3), a BG meter reading is required at least every 12 hours to calibrate the sensor. The sensor was previously reviewed and approved under P160017.
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### **Guardian 4 transmitter (MMT-7841)**
The Guardian 4 transmitter is a portable, electrical current meter intended to process, store, and transmit glucose sensor values to the compatible insulin pump. The transmitter sends sensor glucose (SG) values and sensor integrity (SI) data from the Guardian 4 sensor to the MiniMed 780G insulin pump via BLE wireless communication protocol. The Guardian 4 transmitter does not require entry of fingerstick blood glucose measurement for calibration purposes.
### **Guardian 4 sensor (MMT-7040)**
The Guardian 4 sensor is a sterile, single-use, single patient glucose sensing component for continuous monitoring of glucose levels in the user's interstitial fluid for up to seven days. The Sensor is inserted into the subcutaneous tissue using the One-Press Serter and is taped to the user's skin. It connects to the Guardian 4 transmitter, which in turn communicates with the MiniMed 780G Pump.
The Guardian 4 sensor does not require calibration for use with the system. However, every blood glucose (BG) meter reading either entered manually by the user or received from a paired meter is used to calibrate the sensor.
### **One-Press Serter**
The One-Press serter is a sensor insertion device which aids the user in inserting the Guardian Sensor (3) and the Guardian 4 Sensor. The user must use the One-Press Serter in order to insert the Guardian Sensor (3) or the Guardian 4 Sensor. The serter was previously reviewed and approved under P120010/S070.
### **Accu-Chek Guide™ Link Blood Glucose Meter**
The Accu-Chek Guide™ Link Blood Glucose Meter can be used with the MiniMed 780G system. The meter sends blood glucose values to the insulin pump for sensor calibration via a BLE wireless communication protocol. The blood glucose meter was previously reviewed and approved under P160017/S076.
### **Additional System Accessories**
The following additional accessory devices listed in Table 2 are compatible with the MiniMed 780G Insulin Pump:
*Table 2: Accessory Devices*
| Device | Model |
| --- | --- |
| **Reservoirs and Infusion Sets** | **Model Numbers** |
| MiniMed Quick Set infusion set | MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399 |
| MiniMed Silhouette infusion set | MMT-368, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384 |
| MiniMed Mio Infusion set | MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-965, MMT-975 |
| MiniMed Sure-T infusion set | MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886 |
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| Device | Model |
| --- | --- |
| MiniMed Mio Advance infusion set | MMT-213A, MMT-242, MMT-243A, MMT-244A |
| Medtronic Extended infusion set | MMT-430A, MMT-431A, MMT-432A, MMT-433A, MMT-440A, MMT-441A, MMT-442A, MMT-443A |
| MiniMed reservoir | MMT-332A |
| Medtronic Extended reservoir | MMT-342 |
| Optional Devices | Model Numbers |
| MiniMed Mobile Application (Android) | MMT-6101 |
| MiniMed Mobile Application (iOS) | MMT-6102 |
| CareLink Connect Application (Android) | MMT-6111 |
| CareLink Connect Application (iOS) | MMT-6112 |
| Blue Adapter | ACC-190 |
| CareLink Online (Personal) | MMT-7333 |
| CareLink Pro | MMT-7335 |
| Medtronic Diabetes Updates Application (Android) | MMT-6121 |
| Medtronic Diabetes Updates Application (iOS) | MMT-6122 |
This medical device product has functions subject to FDA premarket review as well as functions (e.g., the MiniMed Mobile Applications) that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
## **VI. ALTERNATIVE PRACTICES AND PROCEDURES**
There are several other alternatives for the management of diabetes, including a combination of various therapeutic and behavioral methods.
Self-behaviors including healthy eating, taking the clinically indicated medications (pharmaco-vigilance), and being physically active are fundamental lifestyle activities that are important for achieving glycemic control regardless of the methods of monitoring glucose and insulin administration.
Methods of monitoring glycemic control include periodic measurement of Hemoglobin A1c (HbA1c) which reflects mean blood levels control over a three-month period. This test is ordered and interpreted by the person with diabetes (PWDs) healthcare provider. Self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of blood glucose at a single point in time for PWDs and their
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healthcare providers. This helps to monitor the effectiveness of glycemic control, as well as in making more immediate treatment modifications.
An insulin pump is an alternative to multiple daily insulin injections (via insulin syringe or an insulin pen). PWDs may administer insulin by injection or using other insulin infusion pumps. There are currently several commercially available ambulatory insulin infusion pumps that can be used for insulin infusion. Additionally, sensor-augmented insulin infusion pumps or continuous glucose monitoring systems may be used to record continuous interstitial glucose information and provide real-time alerts for low and high glucose. Several available insulin pump systems offer automated features where insulin delivery may be suspended when sensor glucose has reached or is predicted to reach a user selected low glucose threshold. Hybrid closed loop insulin pump systems are also available for people with type 1 diabetes. These systems can automatically increase or decrease the amount of insulin delivered to maintain glucose within an optimal range.
Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.
## **VII. MARKETING HISTORY**
The MiniMed 780G system has been commercially available in Europe since October 2020.
## **VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH**
Potential device-related serious adverse events include
- Diabetic ketoacidosis (DKA) resulting from high blood glucose due to suspension of insulin delivery or inadequate insulin delivery (which may result from catheter occlusion, hardware or software malfunction, erroneous CGM readings in Auto Mode or suspend mode, or inadequate insulin dosing).
- Severe hypoglycemia resulting from over-delivery of insulin (which can result from hardware or software malfunction, erroneous CGM readings in Auto Mode, or erroneous insulin dosing), which may lead to seizure, unconsciousness and, rarely, death.
Potential device related non-serious events include:
- Skin irritation or redness
- Infection
- Pain or discomfort
- Bruising
- Edema
- Rash
- Bleeding
- Induration of skin
- Allergic reaction to adhesive
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Sensor breakage with fragments retained under the skin is a potential adverse event related to use of the CGM component of the 780G system, but this was not observed during the clinical studies. Based on post-market experience with similar devices and the results observed in the clinical studies described below, the occurrence and severity of these events are low.
Infection at the insulin pump infusion set insertion site and sensor insertion site is a potential complication related to insertion of the CGM or the insulin pump infusion set. Based on post-market experience with similar devices, and the results observed in clinical studies, the occurrence and severity of these events are not expected to differ from other approved infusion sets and CGM devices.
Insulin pump use is known to carry an increased risk of DKA. However, FDA has received information indicating some patients are willing to accept an increased risk of DKA or ketosis and hyperglycemia (severe hyperglycemia) because of the benefits of pump use (see also Section XII below).
Like other insulin pumps, there is an inherent risk that users of the device who do not use the 780G system as intended could harm themselves. Therefore, the device is for prescription use only and contraindicated for people unwilling or unable to perform fingerstick blood glucose meter readings and for people unwilling or unable to maintain contact with their healthcare professional.
As demonstrated under P120010/S046 for the MiniMed 530G system (which has the same 'suspend on low' feature, where insulin delivery will suspend for two hours after the low glucose threshold has been reached), two-hour suspension of insulin delivery is unlikely to lead to clinically significant ketosis or ketoacidosis even if the pump inappropriately suspends when blood sugar is normal or elevated and should respond to insulin therapy and hydration within a few hours.
There is a theoretical risk of insulin over-delivery due to device malfunction which has a risk of leading to severe hypoglycemia due to malfunction of the 780G system. However, this event did not occur during the pivotal study or the continuation phase of the pivotal study. If insulin over-delivery were to occur, there are several mechanisms in place, designed to help detect and mitigate the risk of impending and/or current hypoglycemia, including the presence of alarms/alerts and insulin delivery suspension/reduction.
There is a theoretical risk of insulin under-delivery (due to a hardware or software malfunction) which may lead to severe hyperglycemia or DKA due to malfunction of the 780G system. However, this event did not occur during the pivotal study or the continuation phase of the pivotal study. If insulin under-delivery were to occur, there are mechanisms in place to help detect impending and/or current hyperglycemia, including the presence of alerts and alarms.
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The consequences of falsely high glucose readings on the CGM would be potential over-delivery of insulin via automated insulin delivery and missed low glucose suspensions and alerts/alarms, which have the potential to lead to severe hypoglycemia.
The consequences of falsely low glucose readings on the continuous glucose monitor would be potential under-delivery of insulin and missed high glucose alerts, which have the potential to lead to severe hyperglycemia or DKA.
# IX. SUMMARY OF NONCLINICAL STUDIES
# A. Laboratory Studies
Pre-clinical testing of the MiniMed 770G pump hardware supports the safe use of the 780G pump as these pumps contain identical hardware. Please see the SSED for P160017/S076 for descriptions of pre-clinical testing of the pump hardware.
The Guardian Sensor (3) and One-Press Serter remain unchanged. Please see the SSED for P160017 for descriptions of the pre-clinical testing of the Guardian Sensor (3) and One- Press Serter.
The Guardian Link (3) Transmitter and Accu-Chek Guide™ Link Meter remain unchanged since their approval under P160017/S076. Please see the SSED for P160017/S076 for descriptions of the pre-clinical testing of the Guardian Link (3) Transmitter and Accu-Chek Guide™ Link Meter.
The Guardian 4 sensor is physically the same device as the Guardian Sensor (3) approved under PMA P160017. Therefore, the pre-clinical testing that was approved for the Guardian Sensor (3) under PMA P160017 also applies to Guardian 4 sensor. Please see the SSED for P160017 for descriptions of the pre-clinical testing of the Sensor.
The Guardian 4 transmitter shares the same mechanical and electrical hardware as the Guardian Link (3) transmitter (MMT-7911) (GST5C) approved under P160017/S076. Requirements related to hardware only or hardware interface only features are hence not impacted, and GST5C verification data that was approved under P160017/S076 is applicable to the Guardian 4 transmitter. Please see the SSED for P160017/076 for descriptions of the pre-clinical testing of the transmitter.
Testing was conducted to evaluate the software impact on the transmitter battery. Results confirmed that the battery met all requirements, demonstrating that the software had no effects on transmitter battery performance. Table 3 provides details of the requirements and acceptance criteria.
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*Table 3: Guardian 4 Transmitter (MMT-7841) Battery Life Testing*
| Test | Sample Size | Requirement | Acceptance Criteria | Results |
| --- | --- | --- | --- | --- |
| Battery Life | 29 | GST-PS-345: The GST shall store data for at least the life of the sensor. | The testing must demonstrate that the product stores data for at least the life of the sensor. | Pass |
| | | GST-PS-432: Under normal use, a fully charged GST battery shall operate the device for the duration of 1 sensor use. | The testing must demonstrate that, under normal use and starting at full charge, the product's battery shall operate the device for the duration of 1 sensor use. | |
| | | GST-PS-160: The GST shall transmit an alert at the detection of a depleted battery condition. | The testing must demonstrate that the product transmits an alert at the detection of a depleted battery condition. | |
| | | GST-PS-161: The GST shall transmit an alert at the detection of a low battery condition. | The testing must demonstrate that the product transmits an alert at the detection of a low battery condition. | |
| | | GST-PS-164: The time from the low battery alert to the depleted battery alert shall be at least 1 day under normal use. | The testing must demonstrate that the time from the low battery alert to the depleted battery alert is at least 1 day under normal use. | |
| | | GST-HRS-210: The memory shall store data for at least the life of the sensor per sensor life. | The testing must demonstrate that the memory shall store data for at least the life of the sensor per sensor life. | |
| | | GST-HRS-203: A fully charged GST battery shall operate the device for at least the life of the sensor. | The testing must demonstrate that, starting at full charge, the product battery shall operate the device for at least the life of the sensor. | |
#### MiniMed 780G System
System testing of the MiniMed 770G system supports the safe use of the 780G system as the system hardware components (i.e., pump, transmitters, and blood glucose meter) remain unchanged since their approval as part of the 770G system under P160017/S076. Application-level verifications were performed on the full MiniMed 780G system (i.e. MiniMed 780G pump, transmitters, BG meter, MiniMed Mobile App, CareLink, and CareLink Connect App) to ensure that the devices are
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compatible, and that data is successfully transferred. Please see the SSED for P160017/S076 for all other system testing.
### **Packaging**
Pre-clinical testing performed on the MiniMed 770G pump hardware and packaging supports the 780G pump as the corresponding pump hardware and packaging are identical. Please see the SSED for P160017/S076 for packaging validation.
Please see the SSED for P160017 for descriptions of the pre-clinical packaging validation conducted for the Guardian Link (3) Transmitter and Guardian Sensor (3) and Guardian 4 Transmitter and Guardian 4 Sensor.
### **Software**
Comprehensive verification and validation testing were conducted to confirm that the software used in the MiniMed 780G system meets all specified requirements and that the software will operate reliably and safely under normal or abnormal use conditions.
Software verification and validation were conducted in accordance with the FDA Guidance Document entitled *General Principles of Software Validation: Final Guidance for Industry and FDA Staff* (issued on January 11, 2002). Software development activities included establishing detailed software requirements, linking requirements with associate verification tests, software code reviews, unit testing, system level testing and defect tracking and dispositioning to ensure the software conforms to user needs and intended uses.
### **Firmware Over the Air (FOTA)**
The MiniMed 780G pump has the capability to securely receive and install firmware-over-the-air (FOTA) updates, via the FOTA app. Verification of the FOTA functionality in the MiniMed 770G pump software, which supports safe use of the FOTA feature, is applicable to the 780G pump as the FOTA architecture and components are identical for both pumps.
### **Human Factors Testing**
Human Factors usability validation studies were conducted in alignment with the IEC 62366-1 standard entitled *Medical Devices – Application of Usability Engineering to Medical Devices* and the FDA Guidance Document entitled *Applying Human Factors and Usability Engineering to Medical Device*.
The applicant conducted usability validation studies to evaluate use of the MiniMed 780G system by patients with type 1 diabetes mellitus ages 7 years and older. These studies address use of the 780G system with compatible CGMs: Guardian 3 Sensor / Guardian Link 3 Transmitter and Guardian 4 sensor / Guardian 4 transmitter.
For use of the 780G system with the Guardian 3 CGM, Medtronic conducted two
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usability studies. In the first usability study, users representing both adult and pediatric pump users (some with a caregiver) with varying levels of pump experience performed critical tasks associated with using the MiniMed 780G system in both Manual and Auto Modes. Task Analyses were conducted to determine 780G system critical tasks. Representative user groups were identified as follows:
- Novice Insulin Pump Users (pediatric and adult).
Users in these groups were new to insulin pump and used injections, shots or insulin pens only.
- Experienced Insulin Pump Users (pediatric and adult).
Users in these groups were using any insulin pump except 670G.
- Current 670G Insulin Pump Users (pediatric and adult).
Users in these groups were using the 670G Insulin Pump at the time and were on Auto Mode for at least 1 month.
In a supplementary usability study, users representing only novice adult and pediatric pump users (some with a caregiver) performed critical tasks associated with using the 780G system in both Manual and Auto modes. Representative users were new to insulin pumps and CGM and used injections, shots or insulin pens only. For use of the 780G system with the Guardian 4 CGM, a human factors assessment was performed to evaluate usability risks as compared to use of the 780G system with the Guardian 3 CGM (assessed as described above). All workflow and potential use errors for Guardian Sensor (3) and Guardian 4 sensor were found to be equivalent when used adjunctively. Thus, the results of human factor validation studies for the Guardian 3 CGM are applicable to the Guardian 4 CGM.
For all the usability studies conducted, all use errors, close calls and use difficulties observed during completion of critical tasks were analyzed, and the root causes and impacts were assessed. For any use errors and close calls, a residual risk analysis was performed to: (a) determine whether design changes would further reduce the risks, and (b) assess the residual risks in relation to the benefits to the patient. It was determined that no design changes were necessary. Overall, the human factors usability validation studies and assessment demonstrated that the MiniMed 780G system, used with either the Guardian 3 CGM or the Guardian 4 CGM, is safe and effective for use by patients ages 7 years and older with type 1 diabetes.
**B. Animal Studies**
None
**C. Additional Studies**
None
**X. SUMMARY OF PRIMARY CLINICAL STUDY(IES)**
A pivotal clinical study was performed using the MiniMed 670G 4.0 insulin pump, which contains the same Advanced Hybrid Closed Loop (AHCL) algorithm as the
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MiniMed 780G insulin pump, the Guardian Sensor (3) and the Guardian Link (3) Transmitter. The applicant also conducted a clinical study of the Guardian 4 sensor with the Guardian 4 transmitter.
A brief summary of the supporting clinical studies is presented below in Table 4.
*Table 4: Summary of P160017/S091 Clinical Studies*
| Clinical Study | Patient Population | Study Design/Objective |
| --- | --- | --- |
| Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects. | 7-75 years | Multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes. The objective of the study is to collect in-home data using the AHCL system. |
| Performance Evaluation of an Advanced Algorithm with CGM in Adults, Adolescents, and Pediatrics | 7-80 years | Multi-center, randomly assigned, prospective, single-sample correlational design without controls. The primary objective of the study is to demonstrate the accuracy of G4S when used over a period of 7 days (i.e., 170 hours) with the system in subjects 2-80 years of age. |
# **Pivotal Study: Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects:**
# **A. Study Design**
The study was a multi-center, single-arm study for adult and pediatric subjects with type 1 diabetes in a home setting. Subjects were treated between June 7, 2019 and March 17, 2021.
A total of 329 subjects aged 7–75 years with type 1 diabetes were enrolled at 19 investigational sites across the United States, and 275 of those subjects completed the study period. Of the 275 subjects who completed the study, 151 were age 7-17 years and 124 were age 18 and older (see subject accountability below).
Subjects who completed the study period wore the MiniMed 670G 4.0 pump with the Guardian Link (3) Transmitter, the Guardian Sensor (3) and infusion sets for approximately 4-5 months and participated in all study phases: a two-week run-in
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period and 90-day at-home use period. Subjects were instructed to use the device in Auto Mode for the duration of the 90-day at-home study.
# Run-in period
The run-in period allowed subjects to become familiar with the new study devices. During this period, subjects used the Study Pump (MiniMed 670G 4.0) without activating the auto correction feature.
Subjects were asked to complete a Regular Sized Dinner Challenge with Missed Meal Bolus, in which the subject consumed dinner without administering a Meal Bolus. Subjects were asked to check BG at the start of the meal, as well as 2 hours and 4 hours after the meal, and provide correction boluses as necessary.
# Study Period
All subjects continued using the Study Pump and began to use the pump in Auto Mode for 90 days during the study period. Subjects were expected to use the pump in Auto Mode for the entire study period. If subjects were kicked out of Auto Mode, they were expected to try to mitigate the issue and return to Auto Mode as soon as possible. Per investigator discretion, subjects' target basal setpoint was set at either 100 mg/dL or 120 mg/dL to start the study period and the setpoint was changed after 45 days (± 5 days) of the study period. For example: a subject who started the study period with the 100 mg/dL setpoint underwent a change to the 120 mg/dL setpoint after 45 days. Subjects were also asked to complete a series of meal and exercise challenges during this period.
# 1. Clinical Inclusion and Exclusion Criteria
Subjects were considered for enrollment in the study if they met all of the following criteria:
# General Inclusion Criteria
1. Subject is age 7–75 years at time of screening
2. Subjects 14–75 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Subjects 7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
# Study-Specific Inclusion Criteria
4. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
5. Subject is willing to perform required sensor calibrations
6. Subject is willing to wear the system continuously throughout the study
7. Subject must have a minimum daily insulin requirement (Total Daily
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Dose) of greater than or equal to 8 units
8. Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of Screening visit
Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
9. Subject has TSH in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
10. Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
11. Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in the same building (or home). A companion or caregiver should also be available during exercise challenges in the same building, home or location (if not at home). This requirement may be verified by subject report at screening visit.
12. Subject willing to upload data from the study pump, must have Internet access and a computer system that meets the requirements for uploading the study pump
13. If subject has celiac disease, it has been adequately treated as determined by the investigator
14. Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e., co-payments for insulin with insurance or able to pay full amount)
- Humalog™* (insulin lispro injection)
- NovoLog™* (insulin aspart)
15. Subjects with history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
16. Subjects with 3 or more of the cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
a. Cardiovascular risk factors include:
- Age >35 years
- Type 1 diabetes of >15 years' duration
- Presence of any additional risk factor for coronary artery disease
- Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
- Presence of peripheral vascular disease
- Presence of autonomic neuropathy
Subjects with history of cardiovascular event 1 year or more from the time of screening must have a stress test within 6 months prior to screening or during run
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in period. If subject fails stress test, participation is allowed if there is clearance from a cardiologist
Subjects were not permitted to enroll in the pivotal study if they met any of the following criteria:
### Exclusion Criteria
1. Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening:
a. Medical assistance (i.e., Paramedics, Emergency Room (ER) or Hospitalization)
b. Coma
c. Seizures
2. Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
3. Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
4. Subject has Hypoglycemia Unawareness, measured by the Gold questionnaire as ≥ 4 (Gold, Macleod et al. 1994) at Screening
5. Subject is unable to tolerate tape adhesive in the area of sensor placement
6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
7. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
8. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
9. Subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
10. Subject is being treated for hyperthyroidism at time of Screening
11. Subject has a diagnosis of adrenal insufficiency
12. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
13. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
14. Subject is currently abusing illicit drugs
15. Subject is currently abusing marijuana
16. Subject is currently abusing prescription drugs
17. Subject is currently abusing alcohol
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18. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Screening
19. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
20. Subject has elective surgery planned that requires general anesthesia during the course of the study
21. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening
22. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
23. Subject diagnosed with current eating disorder such as anorexia or bulimia
24. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
25. Subject has a hematocrit that is below the normal reference range of lab used.
26. Subject is on dialysis
27. Subject has serum creatinine of >2 mg/dL.
28. Research staff involved with the study.
# 2. Follow-up Schedule
There were four scheduled office visits throughout the run-in period. During the first visit, subjects were screened for eligibility and were asked to complete questionnaires about their experience with their currently used device and had blood collected for an HbA1c test. The remaining visits were meant to allow the subjects to familiarize themselves with the study devices.
Throughout the study period there were a number of scheduled visits (telephone calls and office visits). These visits were meant to ensure that the subject was healthy and to remind them to adhere to the study requirements, for example, reminders to only insert glucose sensors in locations that are specified in the User Guide materials.
During the final visit, subjects were asked to complete some questionnaires about their experience and also had blood collected for an HbA1c test.
# 3. Clinical Endpoints
There were no statistically powered endpoints in the pivotal study, nor was there any hypothesis testing. This was a descriptive study to evaluate the safe use of the AHCL system.
# Descriptive Endpoints
- The mean change in HbA1c will be presented from baseline to end of study
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period
- Change of Total Daily Dose (TDD) of insulin from baseline to end of study period
- Change of weight from baseline to end of study period
- Time spent in Auto Mode versus time spend in Manual Mode
- Time in different range (% of SG): SG < 50, 54, 60, 70 mg/dL, SG > 140, 180, 250, 350 mg/dL
- Number of Events, Area Under Curve (AUC) and Time in the hyperglycemic range: sensor glucose (SG) > 140, 180, 250, 350 mg/dL
- Number of Events, AUC and Time in the hypoglycemic range: SG < 50, 54, 60, and 70 mg/dL
o Change in BG values during meal challenge (BG prior and BG 2 hours after meal)
o Change in % of time in euglycemia (70-180 mg/dL) during meal challenge, prior and 2 hours after meal
o Difference in AUC during meal challenge prior and 2 hours after meal
• Analysis will be performed for
o Age
• 7–13
• 14–75
o Setpoint
• 100 mg/dL
• 120 mg/dL
o Temp Target usage
• Yes
• No
# Safety Data Summarized
- Serious Adverse Event (SAE)
- Serious Adverse Device Effects (SADE)
- Unanticipated Adverse Device Effect (UADE)
- Incidence of Severe Hypoglycemia
- Incidence of DKA
# B. Accountability of PMA Cohort
A total of 299 subjects entered the run-in period, 10 subjects withdrew during the run-in period and 289 entered the study period: 161 subjects aged 7-17 years and 128 subjects aged 18-75 years. Ten (10) subjects aged 7-17 years and four (4) subjects aged 18-75 years withdrew during the study period. Therefore, a total of 275 subjects completed the study period: 151 subjects aged 7-17 years and 124 subjects aged 18-75 years.
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### C. Study Population Demographics and Baseline Parameters
The demographics of the study population as listed in Table 5 are typical for studies performed in the Type 1 diabetes population in the US.
*Table 5: Study Demographics*
| Characteristic | Subjects 7-17-years-old Number of Subjects = 160* | Subjects 18-75-years-old Number of Subjects = 128 |
| --- | --- | --- |
| **Age (Years)** | | |
| n | 160 | 128 |
| Mean (SD) | 11.3 (2.5) | 43.5 (15.2) |
| Median | 11.0 | 45.5 |
| Min, Max | 7.0, 17.0 | 18.0, 75.0 |
| **Gender N(%)** | | |
| Female | 83 (51.9%) | 69 (53.9%) |
| Male | 77 (48.1%) | 59 (46.1%) |
| **Race N(%)** | | |
| White | 144 (90.0%) | 123 (96.1%) |
| Asian | 3 (1.9%) | 2 (1.6%) |
| American Indian or Alaska Native, White | 1 (0.6%) | 0 (0.0%) |
| Asian, White | 3 (1.9%) | 0 (0.0%) |
| Black/African American | 4 (2.5%) | 1 (0.8%) |
| Native Hawaiian or Other Pacific Islander | 1 (0.6%) | 0 (0.0%) |
| Other | 4 (2.5%) | 2 (1.6%) |
| **Ethnicity N(%)** | | |
| Hispanic Or Latino | 12 (7.5%) | 7 (5.5%) |
| Not Hispanic Or Latino | 148 (92.5%) | 120 (93.8%) |
| Not Reported | 0 (0.0%) | 1 (0.8%) |
| **Diabetes History (Years)** | | |
| n | 160 | 128 |
| Mean (SD) | 6.2 (2.9) | 25.8 (12.7) |
| Median | 5.8 | 23.7 |
| Min, Max | 1.1, 15.0 | 3.9, 60.7 |
| **Height (cm)** | | |
| n | 160 | 128 |
| Mean (SD) | 150.5 (15.4) | 171.0 (9.4) |
| Median | 151.2 | 170.1 |
| Min, Max | 116.2, 200.6 | 152.9, 195.0 |
| **Weight (kg)** | | |
| n | 160 | 128 |
| Mean (SD) | 45.8 (14.8) | 83.3 (18.5) |
| Median | 43.1 | 80.2 |
| Min, Max | 21.4, 91.9 | 57.7, 165.9 |
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| Characteristic | Subjects 7-17-years-old Number of Subjects = 160* | Subjects 18-75-years-old Number of Subjects = 128 |
| --- | --- | --- |
| **BMI (Kg/m2)** | | |
| n | 160 | 128 |
| Mean (SD) | 19.7 (3.5) | 28.4 (5.6) |
| Median | 18.8 | 27.1 |
| Min, Max | 14.1, 33.4 | 18.3, 51.2 |
| **Baseline A1C (%)** | | |
| n | 160 | 128 |
| Mean (SD) | 7.9 (0.9) | 7.4 (0.8) |
| Median | 7.9 | 7.5 |
| Min, Max | 6.1, 9.9 | 5.7, 9.8 |
*Although 161 subjects entered the Study Period, one subject exited the Study Period without using Auto Mode
### D. Safety and Effectiveness Results
#### 1. Safety Results
The safety of the device was assessed by evaluating the incidence of all serious Adverse Events (AEs), Adverse Device Events (ADEs), Serious Adverse Device Events (SADEs), and Unanticipated Adverse Device Effects (UADEs) experienced by study subjects. AEs were listed in terms of severity and relationship to the device.
Subjects 7-17 Years of Age:
There were two (2) reports of serious adverse events:
- One (1) event was an incident of severe hypoglycemia during the run-in period. This event was determined to be neither device nor procedure related but was considered serious due to reported seizure. The subject recovered after receiving a 1 mg dose of glucagon and eating peanut butter and more carbs. There were no subsequent lows. The subject was in manual mode at the time of the event and did not treat or respond to low alerts prior to the severe hypoglycemia event.
- Another event was presented to the emergency department (ED) with abdominal pain during the study period. BG was 113 mg/dL and ketones were 0.4. Subject was administered IV fluids and 4 mg oral ondansetron. Subject turned off Auto Mode but remained on pump and was admitted to hospital for overnight observation. Subject was discharged the next day with symptoms resolved. DKA ruled out, primary diagnoses were dehydration and constipation. This event was determined to be neither device nor procedure related and was resolved without infusion set change.
There were no reports of unanticipated serious adverse device effects.
There were no reports of unanticipated non-serious adverse device/procedure effects.
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There were no reports of diabetic ketoacidosis events,
There were 39 severe hyperglycemia events reported.
Severe hyperglycemia was defined in the protocol as a glucose concentration >300 mg/dL (or 16.7 mmol/L) with blood glucose ketones greater than (>) 1.5 mmol/L, urine ketones moderate or large, or accompanied by symptoms of nausea, vomiting or abdominal pain.
Of the 39 reported severe hyperglycemia events, 22 were thought to be device-related. The 22 device-related severe hyperglycemia events were believed to be due to infusion set issues (i.e., occlusion, bent cannula or cannula pull out).
# Subjects 18-75 Years of Age:
There were two reports of serious adverse events. These events were an incident of appendicitis and an incident of sepsis secondary to pyelonephritis and were not related to the study device.
There were no reports of unanticipated serious adverse device effects.
There were no reports of unanticipated non-serious adverse device/procedure effects.
There were no reports of diabetic ketoacidosis events.
There were no reports of severe hypoglycemia events.
There were 4 severe hyperglycemia events reported. Of the 4 reported severe hyperglycemia events, 3 were thought to be device-related. The 3 device-related severe hyperglycemia events were believed to be due to infusion set issues (i.e., occlusion, bent cannula or cannula pull out).
# Adverse effects that occurred in the PMA clinical study:
There were no reports of unanticipated serious adverse device effects.
There were no reports of unanticipated non-serious adverse device/procedural effects.
There were no reports of diabetic ketoacidosis events.
There was one event of severe hypoglycemia reported.
# 2. Effectiveness Results
The data below describes how the device performed during the AHCL pivotal study. This study compared the results of subjects prior to using the auto correction bolus (run-in period - 2 weeks) against results while using the auto correction bolus (study period - 3 months). However, the study did not evaluate subjects who were not using a system equipped with the auto correction bolus
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(i.e., there was no control group).
Table 6 below provides an overall summary of the run-in period and study period for all subjects with Auto Mode enabled in the study period. Table 7 and Table 8 provide mean sensor glucose values in specific glucose ranges during run-in, day 1, and study period. The data below suggest that adult subjects spent more time in range (70–180 mg/dL), less time in hypoglycemia (<70 mg/dL) and less time in hyperglycemia (>180 mg/dL) during the study period compared with the run-in period. Pediatric subjects spent more time in range (70-180 mg/dL and less time in hyperglycemia (>180 mg/dL) without increasing time in hypoglycemia (<70 mg/dL) during the study period compared with the run-in period.
Table 6: Mean Sensor Glucose during Run-in and Study Period with 780G/GS3
| Parameter | Age 7-17 Years (n=160) | | Age 18-75 Years (n=128) | |
| --- | --- | --- | --- | --- |
| | Run-In | Study | Run-In | Study |
| Sensor Glucose, (mg/dL) Mean (SD), (95% CI) | 168.8 (19.9), (165.7, 171.9) | 152.7 (10.6), (151.0, 154.3) | 151.1 (15.1), (148.5, 153.8) | 147.4 (10.7), (145.5, 149.3) |
Table 7: Mean Percent Sensor Glucose Values in Specific Glucose Ranges (Mean ± SD) with 780G/GS3 for Day 1, Run-in, and Study Period
| Glucose Range (mg/dL) | Age 7-17 Years (n=160) | | | Age 18-75 Years (n=128) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Run-In | Study Period (Day 1) | Study Period (Overall) | Run-In | Study Period (Day 1) | Study Period (Overall) |
| < 50 | 0.4 ± 0.5 | 0.5 ± 0.6 | 0.4 ± 0.4 | 0.5 ± 0.7 | 0.4 ± 0.6 | 0.3 ± 0.4 |
| < 54 | 0.7 ± 0.7 | 0.7 ± 0.7 | 0.6 ± 0.5 | 0.8 ± 1.1 | 0.7 ± 0.8 | 0.5 ± 0.6 |
| < 60 | 1.2 ± 1.1 | 1.3 ± 1.1 | 1.2 ± 0.8 | 1.4 ± 1.7 | 1.2 ± 1.2 | 1.0 ± 0.9 |
| < 70 | 2.7 ± 2.0 | 3.0 ± 1.8 | 2.7 ± 1.6 | 3.4 ± 3.0 | 2.8 ± 2.2 | 2.3 ± 1.7 |
| 70–180 | 59.4 ± 11.8 | 67.9 ± 8.4 | 70.3 ± 6.5 | 70.5 ± 9.8 | 73.5 ± 8.8 | 75.0 ± 7.2 |
| > 180 | 38.0 ± 12.4 | 29.2 ± 8.4 | 27.0 ± 6.7 | 26.2 ± 10.2 | 23.7 ± 9.0 | 22.6 ± 7.4 |
| > 250 | 12.1 ± 7.5 | 8.5 ± 4.9 | 7.1 ± 3.8 | 5.5 ± 4.1 | 5.1 ± 4.2 | 4.4 ± 3.0 |
| > 350 | 1.3 ± 1.6 | 0.8 ± 1.0 | 0.7 ± 0.8 | 0.4 ± 0.6 | 0.4 ± 0.7 | 0.3 ± 0.4 |
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The pivotal study included a continued access phase whereby subjects transitioned from the MiniMed 670G 4.0 system to the MiniMed 780G system with Guardian 4 Sensor and Guardian 4 transmitter. The study results are comparable for the MiniMed 780G system. Table 8 provides the mean sensor glucose values in specific glucose ranges for 780G system with the Guardian 4 CGM for Day 1 and the study period.
Table 8: Mean Percent Sensor Glucose Values in Specific Glucose Ranges (Mean ± SD) with 780G/GS4 for Day 1 and Study Period
| Glucose Range (mg/dL) | Age 7-17 Years (n=160) | | Age 18-75 Years (n=128) | |
| --- | --- | --- | --- | --- |
| | Study Period (Day 1) | Study Period (Overall) | Study Period (Day 1) | Study Period (Overall) |
| < 50 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 |
| < 54 | 0.5 ± 0.6 | 0.4 ± 0.4 | 0.4 ± 0.4 | 0.3 ± 0.3 |
| < 60 | 1.0 ± 0.9 | 0.8 ± 0.7 | 0.7 ± 0.7 | 0.5 ± 0.5 |
| < 70 | 2.3 ± 1.6 | 2.2 ± 1.4 | 1.9 ± 1.4 | 1.6 ± 1.1 |
| 70–180 | 67.3 ± 9.8 | 71.5 ± 7.8 | 72.6 ± 10.8 | 76.6 ± 9.0 |
| > 180 | 30.4 ± 10.0 | 26.3 ± 8.1 | 25.5 ± 11.0 | 21.8 ± 9.3 |
| > 250 | 9.2 ± 6.3 | 6.9 ± 4.5 | 5.7 ± 5.5 | 4.2 ± 3.8 |
| > 350 | 1.2 ± 2.0 | 0.7 ± 1.1 | 0.4 ± 1.0 | 0.3 ± 0.5 |
Each subject's baseline HbA1c value was collected at enrollment. The end-of-study HbA1c was collected at the last visit of the study period. The mean change in HbA1c from the first visit and last visit was analyzed and found to be -0.5% for both subject groups, 7-17 years of age and 18-75 years of age (with 95% confidence intervals of -0.6 to -0.4). A summary of HbA1c data is provided in Table 9 below.
Table 9: Percent Change in HbA1c from Baseline to End of Study
| Category | Subject 7-17 Years of Age | | | Subject 18-75 Years of Age | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Baseline (SD) | End of Study (SD) | Change from Baseline to End of Study (SD) | Baseline (SD) | End of Study (SD) | Change from Baseline to End of Study (SD) |
| Number of Subjects | 160 | 136 | 136 | 128 | 127 | 127 |
| HbA1c, %, Mean (SD) | 7.9 (0.9) | 7.4 (0.7) | -0.5 (0.7) | 7.4 (0.8) | 6.9 (0.5) | -0.5 (0.6) |
| HbA1c, %, Median | 7.9 | 7.3 | -0.5 | 7.5 | 7 | -0.4 |
| 95% Confidence Interval | (7.8, 8.0) | (7.3, 7.5) | (-0.6, -0.4) | (7.3, 7.6) | (6.9, 7.0) | (-0.6, -0.4) |
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| Category | Subject 7-17 Years of Age | | | Subject 18-75 Years of Age | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Baseline (SD) | End of Study (SD) | Change from Baseline to End of Study (SD) | Baseline (SD) | End of Study (SD) | Change from Baseline to End of Study (SD) |
| HbA1c, %, Min, Max | 6.1, 9.9 | 6.2, 9.1 | -2.7, 1.7 | 5.7, 9.8 | 5.9, 8.6 | -2.8, 0.7 |
Table 10 below summarizes time spent in Auto Mode and sensor usage from the start of the study period until the end of the study period. This data shows that subjects were in Auto Mode for greater than 90% of the time.
Table 10: Summary of Sensor Usage and Time Spent in Auto Mode, From Start of Auto-Mode to End of the Study Period
| Category | Percentage of Time | |
| --- | --- | --- |
| | Subject 7-17 Years of Age | Subject 18-75 Years of Age |
| Time spent using sensor | 88.0% | 91.2% |
| Time spent not using sensor | 12.0% | 8.8% |
| Time spent in Auto Mode | 93.5% | 95.2% |
| Time spent in Manual Mode | 6.5% | 4.8% |
During the study, subjects performed meal challenges which involved eating a meal without giving a meal bolus. These challenges were intended to evaluate how subjects' glucose would respond when a meal dose is occasionally missed. Missed meal boluses when in Auto Mode with the auto correction bolus enabled at the 100 mg/dL and 120 mg/dL SG setpoints were compared to missed meal boluses when in Manual mode. Table 11 below shows the mean SG values up to two hours before, and 1 to 3 hours after, a regular-sized dinner with a missed meal bolus during the run-in and study periods.
Although the goal is to spend more time in range (70-180 mg/dL), patients SG values may rise to the hyperglycemic range (>180 mg/dL) if they do not bolus when they eat.
Table 11: Mean SG values During Regular Sized Dinner with Missed Meal Bolus, Analysis for Data Collected During Run-In and Study Period
| Category | Subject 7-17 Years of Age (N=94) | | | Subject 18-75 Years of Age (N=70) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Baseline | Study Period | | Baseline | Study Period | |
| | | Setpoint 100 mg/dL | Setpoint 120 mg/dL | | Setpoint 100 mg/dL | Setpoint 120 mg/dL |
| Mean SG before | 140.6 ± | 152.9 ± | 151.5 ± | 132.9 ± | 138.0 ± | 139.8 ± |
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| Category | Subject 7-17 Years of Age (N=94) | | | Subject 18-75 Years of Age (N=70) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Baseline | Study Period | | Baseline | Study Period | |
| | | Setpoint 100 mg/dL | Setpoint 120 mg/dL | | Setpoint 100 mg/dL | Setpoint 120 mg/dL |
| meal (mg/dL), Mean ± SD | 48.0 | 50.5 | 43.6 | 42.3 | 51.5 | 38.7 |
| Mean SG 2 Hours after meal (mg/dL), Mean ± SD | 255.6 ± 65.0 | 204.7 ± 53.8 | 202.6 ± 51.4 | 210.5 ± 53.3 | 198.8 ± 53.3 | 203.1 ± 41.6 |
| Change in Mean SG before and after the meal (mg/dL), Mean ± SD | 115.0 ± 81.6 | 51.8 ± 62.3 | 51.0 ± 71.3 | 77.6 ± 68.5 | 60.8 ± 75.0 | 63.4 ± 60.7 |
During the study period, subjects exercised on 3 consecutive days while in Auto Mode with the auto correction bolus enabled at the 100 mg/dL and 120 mg/dL setpoints, with the Temp Target feature turned ON. Temp Target allows the user to temporarily change the SG setpoint to 150 mg/dL. When Temp Target is enabled, Auto Mode reverts to the previous SG setpoint after the user-set time at the 150 mg/dL setpoint elapses. Table 12 below shows the mean SG values up to two hours before, and 1 to 3 hours after, exercise during the study period only.
*Table 12: Change in Mean SG values During Exercise*
| Category | Subject 7-17 Years of Age (N=131) | | Subject 18-75 Years of Age (N=115) | |
| --- | --- | --- | --- | --- |
| | Setpoint 100 mg/dL | Setpoint 120 mg/dL | Setpoint 100 mg/dL | Setpoint 120 mg/dL |
| Mean SG before exercise (mg/dL), Mean ± SD | 154.6 ± 30.0 | 156.4 ± 34.8 | 141.6 ± 30.3 | 154.0 ± 30.9 |
| Mean SG 2 Hour after exercise (mg/dL), Mean ± SD | 149.9 ± 31.7 | 151.2 ± 33.4 | 134.1 ± 26.8 | 141.7 ± 31.4 |
| Change in Mean SG before and after exercise (mg/dL), Mean ± SD | -4.7 ± 42.1 | -5.2 ± 42.0 | -7.5 ± 36.0 | -12.3 ± 43.1 |
The two tables below, Table 13 and Table 14 show the results when subjects' pumps were programmed to setpoints of 100 mg/dL and 120 mg/dL, while also programmed to different active insulin times (AITs) according to the subjects' needs. These results show that subjects spent more time in range (70-180 mg/dL) from programming the setpoint to 100 mg/dL and the AIT to 2-3 hours.
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Table 13: Glycemic Control Outcomes by Active Insulin Time, Setpoint 100 mg/dL* #
| Category | Subject 7-17 Years of Age | | | Subject 18-75 Years of Age | | |
| --- | --- | --- | --- | --- | --- | --- |
| | AIT 120-180 minutes | AIT 195-240 minutes | AIT>240 minutes | AIT 120-180 minutes | AIT 195-240 minutes | AIT>240 minutes |
| Number of Subjects | 107 | 52 | 2 | 74 | 54 | 4 |
| Overall Average SG (mg/dL) | 148.0 ± 11.8 (147.5) | 153.1 ± 12.7 (151.2) | 155.4 ± 9.1 (155.4) | 141.4 ± 11.2 (141.0) | 145.3 ± 10.4 (144.3) | 145.1 ± 17.3 (150.8) |
| Overall SD SG (mg/dL) | 56.7 ± 8.9 (56.1) | 61.4 ± 8.7 (60.5) | 61.6 ± 8.8 (61.6) | 48.8 ± 7.9 (48.6) | 51.8 ± 8.1 (50.8) | 53.9 ± 7.8 (54.4) |
| Overall CV SG (%) | 38.2 ± 4.3 (37.4) | 40.0 ± 4.2 (39.6) | 39.5 ± 3.3 (39.5) | 34.4 ± 4.2 (34.3) | 35.6 ± 4.6 (35.3) | 37.1 ± 1.9 (36.3) |
| SG < 54 mg/dL (%) | 0.7 ± 0.7 (0.5) | 0.8 ± 0.8 (0.7) | 0.3 ± 0.2 (0.3) | 0.7 ± 0.8 (0.4) | 0.6 ± 0.8 (0.3) | 1.4 ± 1.1 (0.9) |
| SG < 70 mg/dL (%) | 3.1 ± 2.0 (2.5) | 3.5 ± 2.3 (3.0) | 2.3 ± 0.5 (2.3) | 2.9 ± 2.2 (2.4) | 2.7 ± 2.2 (2.1) | 4.8 ± 3.2 (3.7) |
| 70-180 mg/dL (%) | 71.9 ± 6.9 (72.0) | 67.8 ± 6.8 (68.6) | 68.0 ± 6.5 (68.0) | 77.4 ± 7.4 (77.5) | 74.8 ± 6.9 (75.7) | 70.6 ± 7.9 (70.2) |
| SG > 180 mg/dL (%) | 25.0 ± 7.1 (24.8) | 28.7 ± 7.5 (27.8) | 29.8 ± 6.0 (29.8) | 19.7 ± 7.5 (19.2) | 22.5 ± 6.9 (21.8) | 24.6 ± 10.1 (26.6) |
| SG > 250 mg/dL (%) | 6.3 ± 3.9 (5.5) | 8.3 ± 4.3 (7.3) | 8.6 ± 4.0 (8.6) | 3.5 ± 2.8 (3.0) | 4.5 ± 3.0 (4.0) | 5.2 ± 3.5 (5.8) |
| *Values are presented by Mean ± SD (Median) except for number of subjects. | | | | | | |
| # Subjects with at least 10 days' worth of CGM data in each AIT category and specific setpoint were included in analysis. | | | | | | |
Table 14: Glycemic Control Outcomes by Active Insulin Time, Setpoint 120 mg/dL* #
| Category | Subject 7-17 Years of Age | | | Subject 18-75 Years of Age | | |
| --- | --- | --- | --- | --- | --- | --- |
| | AIT 120-180 minutes | AIT 195-240 minutes | AIT>240 minutes | AIT 120-180 minutes | AIT 195-240 minutes | AIT>240 minutes |
| Number of Subjects | 122 | 53 | 2 | 76 | 63 | 2 |
| Overall Average SG (mg/dL) | 153.8 ± 10.3 (153.6) | 158.8 ± 11.7 (160.0) | 166.9 ± 11.7 (166.9) | 148.9 ± 10.8 (148.9) | 153.5 ± 10.8 (153.0) | 160.8 ± 16.3 (160.8) |
| Overall SD SG (mg/dL) | 55.4 ± 9.0 (54.2) | 58.5 ± 8.3 (58.9) | 66.2 ± 3.3 (66.2) | 47.5 ± 8.0 (46.7) | 49.8 ± 8.6 (51.1) | 57.0 ± 8.4 (57.0) |
| Overall CV SG (%) | 35.9 ± 4.6 (36.1) | 36.8 ± 4.0 (36.6) | 39.7 ± 0.8 (39.7) | 31.8 ± 4.0 (31.5) | 32.4 ± 4.4 (33.1) | 35.3 ± 1.6 (35.3) |
| SG < 54 mg/dL (%) | 0.6 ± 0.6 (0.4) | 0.6 ± 0.5 (0.4) | 0.7 ± 0.7 (0.7) | 0.4 ± 0.5 (0.3) | 0.4 ± 0.5 (0.2) | 0.3 ± 0.3 (0.3) |
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| Category | Subject 7-17 Years of Age | | | Subject 18-75 Years of Age | | |
| --- | --- | --- | --- | --- | --- | --- |
| | AIT 120-180 minutes | AIT 195-240 minutes | AIT>240 minutes | AIT 120-180 minutes | AIT 195-240 minutes | AIT>240 minutes |
| SG < 70 mg/dL (%) | 2.3 ± 1.6 (1.9) | 2.2 ± 1.3 (2.0) | 2.7 ± 2.0 (2.7) | 2.0 ± 1.7 (1.6) | 1.7 ± 1.3 (1.5) | 1.4 ± 0.4 (1.4) |
| 70-180 mg/dL (%) | 71.1 ± 6.6 (70.9) | 67.4 ± 7.6 (66.7) | 60.6 ± 4.9 (60.6) | 75.8 ± 7.2 (75.9) | 72.5 ± 8.0 (72.4) | 68.1 ± 10.7 (68.1) |
| SG > 180 mg/dL (%) | 26.6 ± 6.8 (26.9) | 30.4 ± 7.8 (31.0) | 36.7 ± 7.0 (36.7) | 22.2 ± 7.6 (21.6) | 25.8 ± 8.2 (25.3) | 30.5 ± 10.3 (30.5) |
| SG > 250 mg/dL (%) | 6.7 ± 3.8 (5.8) | 8.4 ± 4.1 (9.0) | 13.2 ± 4.6 (13.2) | 4.0 ± 3.0 (3.2) | 5.1 ± 3.4 (4.6) | 8.3 ± 4.8 (8.3) |
| *Values are presented by Mean ± SD (Median) except for number of subjects. # Subjects with at least 10 days' worth of CGM data in each AIT category and specific setpoint were included in analysis. | | | | | | |
Table 15 below provides the number of auto bolus events that occurred throughout the study period, glycemic control (i.e., average SG and percentage of SGs within various SG ranges) prior to and after auto bolus events, and the change in each category before and after auto bolus events. During the study period, 88,139 automatic correction boluses were administered for 7–17-year-old subjects and 68,962 automatic correction boluses were administered for 18–75-year-old subjects. The percentage of SGs in the hypoglycemic range (<70 mg/dL) did not increase for either subject population. The data below show that the auto correction bolus feature in the MiniMed 780G is safe.
Table 15: Glycemic Control Prior to and After Auto Bolus Events, Study Period*
| Category | Subject 7-17 Years of Age (N=160) | | | Subject 18-75 Years of Age (N=128) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | 2 hours prior event | 6 hours post event | Change from Prior to Post | 2 hours prior event | 6 hours post event | Change from Prior to Post |
| Number of Auto Bolus Events | 88139 | 88139 | 88139 | 68962 | 68962 | 68962 |
| Sensor Glucose, Mean ± SD (95%CI) | 158.8±10.0 (157.2, 160.4) | 164.0±10.2 (162.4, 165.6) | 5.2±2.8 (4.7, 5.6) | 154.5±10.3 (152.7, 156.3) | 159.1±10.1 (157.3, 160.8) | 4.5±2.8 (4.0, 5.0) |
| | | | | | | |
| SG < 50 mg/dL (%) | 0.3±0.3 (0.3, 0.4) | 0.3±0.3 (0.2, 0.3) | -0.1±0.1 (-0.1, -0.0) | 0.3±0.3 (0.2, 0.3) | 0.2±0.3 (0.2, 0.2) | -0.1±0.1 (-0.1, -0.0) |
| SG < 54 mg/dL (%) | 0.5±0.4 (0.4, 0.6) | 0.4±0.4 (0.4, 0.5) | -0.1±0.2 (-0.1, -0.1) | 0.4±0.5 (0.3, 0.5) | 0.3±0.4 (0.2, 0.4) | -0.1±0.2 (-0.1, -0.1) |
| SG < 60 mg/dL | 0.9±0.7 (0.8, 1.1) | 0.7±0.6 (0.6, 0.8) | -0.2±0.2 (-0.3, -0.2) | 0.8±0.7 (0.6, 0.9) | 0.6±0.6 (0.5, 0.7) | -0.2±0.3 (-0.2, -0.1) |
| SG < 70 | 2.2±1.3 | 1.6±1.0 | -0.6±0.5 | 1.8±1.3 | 1.3±1.0 | -0.5±0.5 |
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| Category | Subject 7-17 Years of Age (N=160) | | | Subject 18-75 Years of Age (N=128) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | 2 hours prior event | 6 hours post event | Change from Prior to Post | 2 hours prior event | 6 hours post event | Change from Prior to Post |
| mg/dL (%) | (2.0, 2.4) | (1.4, 1.8) | (-0.7, -0.5) | (1.6, 2.0) | (1.1, 1.5) | (-0.6, -0.4) |
| 70-140 mg/dL (%) | 40.4±6.7 (39.4, 41.5) | 37.3±6.2 (36.3, 38.3) | -3.1±2.0 (-3.4, -2.8) | 40.8±8.7 (39.3, 42.3) | 37.7±7.7 (36.3, 39.0) | -3.1±2.6 (-3.6, -2.7) |
| 70-180 mg/dL (%) | 68.8±7.4 (67.6, 70.0) | 66.1±7.6 (64.9, 67.2) | -2.7±1.6 (-3.0, -2.5) | 73.5±8.0 (72.1, 74.9) | 71.2±8.3 (69.7, 72.6) | -2.3±1.5 (-2.6, -2.1) |
| SG >140 mg/dL (%) | 57.4±7.2 (56.3, 58.5) | 61.1±6.5 (60.1, 62.1) | 3.7±2.3 (3.3, 4.0) | 57.4±9.4 (55.8, 59.1) | 61.0±8.1 (59.6, 62.4) | 3.6±2.9 (3.1, 4.1) |
| SG >180 mg/dL (%) | 29.0±7.4 (27.9, 30.2) | 32.3±7.6 (31.1, 33.5) | 3.3±1.7 (3.0, 3.6) | 24.7±8.2 (23.3, 26.1) | 27.5±8.4 (26.1, 29.0) | 2.8±1.7 (2.5, 3.1) |
| SG >250 mg/dL (%) | 6.8±3.7 (6.2, 7.3) | 8.0±4.2 (7.3, 8.6) | 1.2±1.1 (1.1, 1.4) | 4.1±2.9 (3.6, 4.6) | 4.9±3.4 (4.4, 5.5) | 0.8±0.8 (0.7, 0.9) |
| SG >350 mg/dL (%) | 0.6±0.7 (0.5, 0.7) | 0.7±0.8 (0.5, 0.8) | 0.0±0…
