MiniMed 770G System
Device Facts
| Record ID | P160017S076 |
|---|---|
| Device Name | MiniMed 770G System |
| Applicant | Medtronic Minimed, Inc. |
| Product Code | OZP · Clinical Chemistry |
| Decision Date | Aug 31, 2020 |
| Decision | APPR |
| Device Class | Class 3 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The MiniMed 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 770G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
Device Story
MiniMed 770G is a Bluetooth Low Energy (BLE)-enabled hybrid closed-loop insulin pump system; successor to MiniMed 670G. System components: MMT-1880 insulin pump, Guardian Link (3) transmitter, Guardian Sensor (3), One-press serter, and Accu-Chek Guide Link blood glucose meter. Pump receives interstitial glucose data from sensor via transmitter every 5 minutes. SmartGuard algorithm automatically adjusts basal insulin delivery or suspends delivery based on sensor glucose values. Used in home/clinic settings by patients with type 1 diabetes; operated by patients or caregivers. Output displayed on pump screen and mobile app; data transferable to CareLink for remote monitoring by care partners. System aids glycemic control; reduces hypoglycemia/hyperglycemia risk; provides trending data. Requires prescription; mandatory fingerstick calibration ≥2 times/day.
Clinical Evidence
Evidence includes a pivotal multi-center, single-arm home/hotel study (G150247) of 46 pediatric subjects (ages 2-6) and a performance evaluation of the Guardian Sensor (3) (G120262) in 21 subjects. Primary endpoints were descriptive, evaluating safety and HCL algorithm performance. Results showed no DKA or severe hypoglycemia events. HbA1c decreased by -0.5% (95% CI: -0.7 to -0.3). Sensor accuracy was established across 7 days of wear. Data supports safety and effectiveness in the 2-6 year old population.
Technological Characteristics
Ambulatory micro-infusion pump (MMT-1880) using 3.0 mL reservoirs. Sensing via subcutaneous glucose sensor (Guardian Sensor 3) with electrical current measurement. Connectivity via BLE (2.4 GHz). Powered by AA batteries. Software includes SmartGuard HCL algorithm. Sterilization: sterile components (sensor). Standards: EN 60601-1, EN 60601-1-11, ASTM D4169, AAMI TIR 69.
Indications for Use
Indicated for management of type 1 diabetes mellitus in persons 2 years of age and older requiring insulin. Contraindicated for patients requiring <8 units of insulin/day, those unable to perform ≥4 blood glucose tests/day, those unable to maintain contact with healthcare professionals, or those with vision/hearing impairments preventing alarm recognition.
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 670G System (P160017)
Reference Devices
- MiniMed 530G System (P120010)
- MiniMed 630G System (P150001)
- Guardian Connect System (P160007)
- Accu-Chek Guide Blood Glucose Meter (k160944)
Submission Summary (Full Text)
{0}
# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
# I. GENERAL INFORMATION
Device Generic Name: Automated Insulin Dosing System
Device Trade Name: MiniMed 770G 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/S076
Date of FDA Notice of Approval: 8/31/2020
Breakthrough Device: Granted breakthrough device status on July 2, 2019 because the device is expected to provide more effective treatment of type 1 diabetes mellitus, an irreversibly debilitating disease, in the 2-6 years old population for which no approved or cleared alternatives exist.
The MiniMed 670G System (identical to the current MiniMed 770G System except for the lack of bluetooth communication capability) was first approved on September 28, 2016 for use in ages 14 years. The Indications for Use for the MiniMed 670G System were later expanded to include users 7 to 13 years and up and was approved on June 21, 2018. The SSEDs for the original approval (P160017) and the 7-13 years old expansion (P160017/S031) can be found on the CDRH website. The current Panel Track Supplement was to expand the Indications for Use for the MiniMed 770G System to include the 2 to 6 years of age user population (in addition to the previously approved indications of 7 years and older for the MiniMed 670G System); and as well as a change to the pump's wireless protocol from a proprietary approach to Bluetooth Low Energy (BLE).
# II. INDICATIONS FOR USE
# MiniMed 770G System
The MiniMed 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 770G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 1
{1}
(CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
The Medtronic MiniMed 770G System consists of the following devices: MiniMed 770G Insulin Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), one-press serter, the Accu-Chek Guide™ Link blood glucose meter, and the Accu-Chek Guide™ Test Strips. The system requires a prescription.
The Guardian Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian Sensor (3).
# Guardian Sensor (3)
The Guardian Sensor (3) is intended for use with the 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) 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 770G System | 2-13 14 and older | Abdomen and Buttocks Abdomen and Arm |
| 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 770G System. The Guardian Link (3) Transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 770G 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.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 2
{2}
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 770G system with Bluetooth wireless technology through the use of Bluetooth low energy communication.
### III. CONTRAINDICATIONS
A prominent boxed warning is included in the labeling regarding use of the device in users with a total daily insulin dose of less than 8 units:
**“Medtronic performed an evaluation of the 770G closed loop system and determined that it may not be safe for use in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.”**
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 recognition of pump signals and alarms.
- • Do not use serter on products other than the GuardianSensor (3). Medtronic cannot guarantee the safety or efficacy of this product if used with other products.
- • 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 or the infusion of blood or blood products.
- • Insulin pump therapy is not recommended for those who are unwilling to perform at least four BG tests per day. As insulin pumps use rapid-acting insulin only, blood glucose (BG) testing is required to help identify rapid glycemic deterioration due to insulin infusion occlusion, infusion site problems, insulin stability issues, user error, or a combination of these.
- • SmartGuard Auto Mode cannot be used for people who require less than eight units or more than 250 units of total daily insulin dose per day.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 3
{3}
- 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 770G System labeling.
# V. DEVICE DESCRIPTION
The MiniMed 770G System is a Bluetooth Low Energy (BLE)-enabled version of the previously approved MiniMed 670G System (P160017). The MiniMed 770G System has similar interface scheme as the MiniMed 670G System, with the exception that the devices communicate via BLE (2.4 GHz) wireless communication protocols instead of the Tel-D protocol. The use of BLE in the MiniMed 770G System allows the user to optionally use an off-the-shelf suitable consumer electronic device to assist with the management of their therapy. The MiniMed Mobile App provide a secondary display to wirelessly receive data from the pump and to wirelessly transfer pump data to CareLink. Pump data uploaded into CareLink can be used to track patterns and in addition the pump data from CareLink is also remotely viewable via the CareLink Connect App. The CareLink Connect App allows Care Partner (i.e. care giver or health care provider) to remotely monitor glucose levels of a patient via a mobile app.
The MiniMed 770G system is comprised of the following devices:
# MiniMed 770G Pump (MMT-1880)
The MiniMed 770G pump (model MMT-1880) 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 determined basal rate profiles and user selected bolus amounts of insulin into the subcutaneous tissue through an infusion set.
The MiniMed 770G pump is offered in one model (MMT-1880). 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. It is intended to deliver insulin through a diffusion mechanism. Model MMT-1880 is compatible with a 3.0 mL reservoir. The pump only displays blood glucose level units in mg/dL and cannot be reconfigured by the user.
In addition to its delivery of insulin, the MiniMed 770G pump is designed to receive and display real-time interstitial fluid glucose values via the Guardian Link (3) Transmitter. When used in combination with Guardian Sensor (3), the transmitter sends sensor signals to the MiniMed 770G pump via BLE wireless communication protocol every five minutes. The 770G 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 770G System user guide. A summary of these features and capabilities is provided in Table 1 below.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 4
{4}
*Table 1: Summary of the Features of the MiniMed 770G 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 | 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. |
| 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. | This 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 at 50 mg/dL; 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 at 50 mg/dL 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 |
| 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 before Low is turned on. | There is a mandatory severe low alarm at 50 mg/dL 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 user has to turn this mode on and certain pre-defined conditions have to be met. | There is a mandatory severe low alarm at 50 mg/dL; The user can also set optional high and low alerts to sound on or before set sensor glucose levels. |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 5
{5}
| 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 at 50 mg/dL; The user can also set optional high and low alerts to sound on or |
### **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 interfaces directly with the glucose sensor assembly, provides power to the glucose sensor, and measures the sensor signal current from the glucose sensor. The sensor signal current is an electrical current level that is proportional to the glucose level in the user's subcutaneous interstitial fluid. The sensor signal current is converted to a digital signal, which is filtered to reduce noise artifacts. This digital signal is sent to the MiniMed 770G pump every 5 minutes via BLE wireless communication.
### **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 770G Pump.
When making treatment decisions, such as determining insulin dose for meals, the MiniMed 770G continuous glucose monitor (CGM) values should not be used, as they are not intended to be used to make such treatment decisions. The MiniMed 770G CGM does
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 6
{6}
not 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.
Users should calibrate the Guardian Sensor (3) at least every 12 hours using meter blood glucose values. Calibration is necessary for sensor function, and more frequent calibration can help increase the accuracy of the sensor. The system requires a minimum of two calibrations per day, and four calibrations per day are recommended. The system is contraindicated for patients unwilling or unable to do frequent blood glucose meter measurements.
If the user obtains blood glucose values using the Accu-Chek Guide™ Link Meter, the user may transmit blood glucose values via BLE communication to the MiniMed 770G pump to be used for sensor calibrations. If the user uses a different FDA cleared blood glucose meter to calibrate the Guardian Sensor (3), the user must manually input the blood glucose values into the pump to be used for sensor calibration. Additionally, users who use the Accu-Chek Guide™ Link Meter should calibrate with values obtained from measurements of fresh capillary whole blood from the fingertip only. Alternative site testing (i.e., palm or upper arm) should be done only during steady-state times (when glucose is not changing rapidly) and should not be used for calibrating the CGM sensor.
### **One-Press Serter**
The One-Press serter is a sensor insertion device which aids the user in inserting the Guardian Sensor (3). The serter was also previously reviewed and approved under P120010/S070. The user must use the One-Press Serter in order to insert the Guardian Sensor (3).
### **Accu-Chek Guide™ Link Blood Glucose Meter**
The Accu-Chek Guide™ Link Blood Glucose Meter can be used with the MiniMed 770G system. The meter sends blood glucose values to the insulin pump for sensor calibration via BLE wireless communication protocol. This meter is a modified version of the Accu-Chek Guide™ Blood Glucose Meter, which was previously cleared under k160944.
Specifications and performance requirements were previously established for the meter used with the MiniMed 670G system and evaluated as part of the original PMA, P160017. The sponsor validated the Accu-Chek Guide™ Link Blood Glucose Meter and the Accu-Chek Guide™ test strips against the previously established performance requirements. The sponsor provided blood glucose meter specifications, rationale for requirements for the meter, and impact of error on the sensor, predictive low alerts, threshold glucose suspend, and the predictive low glucose management and hybrid closed loop features in the submission. The sponsor carried out error impact analysis in order to determine the lot release criteria for the test strips. The sponsor verified and validated the specifications, performance requirements, and lot release criteria of the Accu-Chek Guide™ Link Blood glucose
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 7
{7}
meter and the Accu-Chek Guide™ test strips for use with the MiniMed 770G System. Based on the information provided, the specifications meet the clinical needs of the MiniMed 770G system.
### **Additional System Accessories**
The following additional accessory devices are compatible with the MiniMed 770G 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- |
| MiniMed Silhouette Infusion Set | MMT-368, MMT-369, MMT-370, MMT-377, MMT-378, MMT-381, MMT-382, MMT- |
| MiniMed Mio Infusion Set | MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, |
| MiniMed Sure-T Infusion Set | MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT- |
| MiniMed Mio Advance | MMT-211, MMT-212, MMT-213, MMT-231, MMT-232, MMT-233, MMT-242, MMT-243, MMT-244, MMT-247, MMT-248, MMT-242T, |
| MiniMed Pro-set | MMT-280, MMT-281, MMT-280T |
| Paradigm Reservoir | MMT-332A |
| **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 |
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.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 8
{8}
## **VI. ALTERNATIVE PRACTICES AND PROCEDURES**
There are several other alternatives for the management of diabetes. Control of diabetes can be achieved through a combination of various behaviors and methods.
Self-behaviors include healthy eating, taking the clinically indicated medications, and being active. Persons with diabetes may also administer insulin by injection or using other insulin infusion pumps as prescribed by their physician. An insulin pump is an alternative to multiple daily insulin injections (via insulin syringe or an insulin pen). Periodic self-glucose monitoring using home-use blood glucose meters provides information regarding variations in glucose levels.
Methods of monitoring glycemic control include periodic measurement of Hemoglobin A1c (HbA1c) which reflects blood glucose control over a three-month period. Self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of blood glucose at a single point in time for users and their healthcare providers. This helps to monitor the effectiveness of glycemic control, as well as make more immediate treatment modifications.
Currently, cleared or approved insulin infusion pumps may be used for continuous subcutaneous insulin infusion. Additionally, commercially available sensor-augmented insulin infusion pumps or continuous glucose monitoring systems may be used to record continuous interstitial glucose information and provide real-time hypoglycemia and hyperglycemia alerts.
Each alternative method for monitoring glycemic control has its own advantages and disadvantages. A user should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.
## **VII. MARKETING HISTORY**
The MiniMed 770G System has not been marketed in the United States or any foreign country.
The MiniMed 770G System is an iteration of the MiniMed 670G System. The MiniMed 670G System was originally approved for marketing in the United States on September 28, 2016 (P160017), and received approval for marketing with a pediatric indication (ages 7-13 years) on June 21, 2018 (P160017/S031). In addition to the device name change, this Panel Track Supplement expands the Indications for Use to include users ages 2-6 years old and updated the communications protocol to BLE. The MiniMed 670G System has not been withdrawn from the market for any reason related to its safety or effectiveness..
The insulin reservoirs and infusion sets used with the MiniMed 770G System are also the same as those currently used with the MiniMed 530G System (P120010), the MiniMed 630G System (P150001), and the MiniMed 670G System (P160017). These devices have not been withdrawn from commercial distribution for any reason, related to either safety or effectiveness.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 9
{9}
## **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
Sensor breakage with fragments retained under the skin is a potential adverse event related to use of the CGM component of the 770G system, but this was not observed during these studies. Based on post-market experience with similar devices and the results observed in these clinical studies, 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 complications 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 these clinical studies, the occurrence and severity of these events are not expected to be different from other approved infusion sets and CGM devices.
Use of insulin pumps are 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 770G system as intended could harm themselves. Therefore, the device is for prescription use only and contraindicated for people unwilling or unable to perform a minimum of four fingerstick blood glucose meter tests per day and for people unwilling or unable to maintain contact with their healthcare professional.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 10
{10}
As demonstrated under P120010/S046 for the MiniMed 530G System (which has the same 'suspend on low' feature, where the 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 the 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 770G System. This even 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 the suspension/reduction of insulin delivery.
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 770G system. 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.
The consequences of falsely high glucose reading on the continuous glucose monitor 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 reading 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 was performed on the MiniMed 770G Pump and the Guardian Link (3) Transmitter for the BLE component and functionality and for other specifications which were impacted by the BLE feature. Some previous pre-clinical testing of the MiniMed 670G hardware and the associated Guardian Link (3) Transmitter supports the safe use of the 770G pump as the corresponding pumps and transmitters contain similar hardware. Please see the SSED for P160017 for all other pre-clinical testing.
Pre-clinical and performance testing of the Accu-Chek Guide™ Link Meter to support safe use of the meter with the MiniMed 770G System was submitted and reviewed to support approval.
The Guardian Sensor (3) and One-Press Serter have not changed. Please see the SSED for P160017 for descriptions of the pre-clinical testing of the Guardian Sensor (3) and One-Press Serter.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 11
{11}
# MiniMed 770G Pump (MMT-1880)
Pumps were subjected to the following functional and environmental tests to ensure that the devices will continue to function normally even when exposed to extreme environmental conditions.
*Table 3: Pump Testing*
| Test | Purpose | Acceptance Criteria Summary | Pass/Fail |
| --- | --- | --- | --- |
| Patient Leakage Current per **EN 60601-1** | Verifies the ability of the NGP's (Next Generation Pump) electrical isolation to provide protection against electric shock of current flowing through | The leakage current shall not exceed 100 µAac (equivalent to 100 mVac) and 10 µAdc (equivalent to 10 mVdc) in normal conditions as described in Table 3 of EN 60601 1 section 8.7.3 | Passed |
| Battery Life | Demonstrates the Alkaline LR6 AA battery's lasting capacity while being used by a Bluetooth enabled NGP during normal everyday use including continuous glucose monitoring | The NGP is operational for a minimum of 7 days while being subjected to the nominal use model with CGM Provides a warning 10 hours ± 2 hours before cessation of delivery due to depletion of battery | Passed |
| Self Test Power Empty Reset | Verifies that the pump can complete a self-test, generate an alarm when a fault in electrical power occurs, and detect an empty reservoir | The NGP shall be able to perform a Self-Test The NGP shall detect an empty reservoir during delivery The NGP shall generate an alarm when it detects a fault in electrical power The NGP shall perform a hard reset of the device when the battery is removed, and back button is held | Passed |
| Mechanical Vibration per **EN 60601-1-11** | Determines ability of the NGP to withstand mechanical vibration that the device may encounter during normal use or in excess of normal use | The NGP shall be able to maintain basic safety and essential performance after exposure to mechanical vibration exposure | Passed |
| Shipment Test per **ASTM D4169** | Determines the durability of the NGP packaging to withstand shipping conditions | Packaging shall be intact Packaging shall protect the product and package contents in such a manner that they are usable by the customer | Passed |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 12
{12}
| | | All labels and barcodes shall be legible and intact | |
| --- | --- | --- | --- |
| AA Compatibility | Verifies the ability of the NGP to Operate with Lithium and Nickel-Metal Hydride | The pump shall Operate with Lithium, Nickel-Metal Hydride, and alkaline AA batteries. Alkaline batteries are the standard battery tested in all other functional cases, so that battery chemistry is covered outside of this protocol | Passed |
| Forced Occlusion | Verifies that the NGP can detect an occlusion condition and generate an alarm to notify the user | The NGP shall detect occlusion during bolus delivery. The NGP shall detect an occlusion within 0.05 mL (5 U) of missed delivery. The NGP shall notify the user with an alarm (audio, tactile or visual) whenever it detects conditions that stop delivery of insulin. | Passed |
| Storage Temperature Humidity | Verifies the ability of the NGP BLE pump to withstand the effects of temperature and humidity during storage | All NGP BLE pumps Operate after exposure to the temperature/humidity Shipping & Storage Environments: -20°C to +50°C and 5% to 95% RH | Passed |
| Mechanical Shock per EN 60601-1-11 | Determines ability of the NGP to withstand mechanical shock that the device may encounter during normal use or in excess of normal use | The NGP BLE Pump shall be able to maintain basic safety and essential performance after exposure to mechanical shock exposure | Passed |
| Temperature Shock | Verifies the ability of the NGP to withstand the effects of extreme and rapid temperature changes during shipping or storage | All pumps can Operate after exposure to 10 cycles of temperature extremes between -20°C and +60°C with a 0.5 hour dwell time at each temperature plateau, and with a minimum rate of change of 10°C per minute, non-operating | Passed |
| Mechanical Drop per EN 60601-1 and EN 60601-1-11 | Determines the ability of the pump hardware to meet drop requirements | Pump maintains basic safety Cessation of delivery must be accompanied by an alarm | Passed |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 13
{13}
| Protection Excessive Temp per EN 60601-1 | Verifies the ability of the NGP BLE pump and its accessories to not produce an excessive temperature when operating in worst case normal use conditions | The NGP and its accessories do not produce excessive temperatures when operating in worst case normal use conditions | Passed |
| --- | --- | --- | --- |
| Operating Temperature Humidity | Determines the ability of the NGP to Operate while withstanding the effects of exposure to temperature and humidity | The pump and its associated consumables shall Operate when exposed to Operating Environments: 5°C to +40°C and 20% to 90% RH | Passed |
| Dielectric Strength | Verifies the NGP maintains its electrical insulation by withstanding the test voltage | The NGP shall withstand the test voltage of 1000 Volts and maintain its electrical insulation. The Hipot Safety Tester generates a PASSED notification and the PASS light illuminates upon completion of the program | Passed |
| Standby Current | Determines the ability of the NGP to consume a maximum current of 1 mA in Standby Mode with a AA battery voltage of 1.5V | The NGP in Standby Mode shall draw a maximum current of 1 mA from a AA battery voltage of 1.5 V | Passed |
| Bolus Delivery | Verifies that the NGP can program a bolus, accurately deliver a bolus, and store bolus information | The motor slide displacement shall be within ±5% of 0.08719 inches (value within 0.08283 inches - 0.09155 inches) the calculated distance traveled to deliver a 25 U Bolus pump shall be able to program and store bolus information | Passed |
## Guardian Link (3) Transmitter (MMT-7911)
Pre-clinical testing of the Guardian Link (3) Transmitter leveraged testing performed for Guardian Connect Transmitter (approved under P160007) as the two transmitters contain identical hardware. Please see the SSED for P160007 for descriptions of the pre-clinical testing of the Guardian Link (3) Transmitter. The following regression functional testing was performed to ensure that the devices will continue to function normally. Battery testing was performed since the change of communication protocol has potential to impact battery life and transmission of alerts.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 14
{14}
*Table 4: Transmitter Testing*
| Test | Purpose | Acceptance Criteria Summary | Pass/Fail |
| --- | --- | --- | --- |
| Battery Life | Demonstrates the battery life and memory capacity of the glucose sensor transmitter (GST) | The GST battery operates the device for the duration of 1 sensor use (a minimum of 7 days and 2 hours or 170 hours total) while being subject to the Nominal Use Model. The GST can also record operation data for the duration of 1 sensor use while being subject to the Nominal Use Model. The time between when the GST advertises the low battery alert to the depleted battery alert is at least 1-day (24 hours) while being subject to the Nominal Use Model. | Passed |
#### MiniMed 770G System
The MiniMed 770G System with all components operating together, including the Guardian Link (3) Transmitter and Accu-Chek Guide™ Link Meter, was subjected to the following functional and environmental tests to ensure that these devices will continue to function normally when exposed to extreme environmental conditions.
Electromagnetic compatibility (EMC) testing of the Guardian Link (3) Transmitter at the device level leveraged testing performed for Guardian Connect Transmitter (approved under P160007) as the two transmitters contain identical hardware configurations. Please see the SSED for P160007 for descriptions of the EMC testing of the Guardian Link (3) Transmitter.
*Table 5: System Testing*
| Test | Purpose | Acceptance Criteria Summary | Pass/Fail |
| --- | --- | --- | --- |
| EMC/EMI Testing per EN 60601-1-2: 2015 | Demonstrate ability of the system to operate in environments with Electromagnetic Interference (EMI) which meet the standard of EN 60601-1-2 | The NGP shall maintain Essential Performance during and after the exposure. Cessation of delivery must be accompanied with an alarm. Isig values recorded during exposure must be within the value specified for the tester unit (TUT) or test plug (TPT) (49.93 – 56.70 nA) | Passed |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 15
{15}
| Test | Purpose | Acceptance Criteria Summary | Pass/Fail |
| --- | --- | --- | --- |
| | | Idle/Alarm Mode - total displacement is less than 0.00348759 inches. Delivery Mode - the motor slide displacement shall be within ±5% of the expected displacement (For examples: 0.0818975 inches is the expected displacement measured at 25.0 U/hr Basal rate in 1 hour). | |
| Wireless Coexistence per AAMI TIR 69 | Determines the ability of the NGP to coexist with other devices operating in the 2.4 GHz frequency band | The NGP shall maintain Essential Performance during and after the exposure. Cessation of delivery must be accompanied with an alarm. Isig values recorded during exposure must be within the value specified for the TUT or TPT (49.93 – 56.70 nA) Idle/Alarm Mode - total displacement is less than 0.00348759 inches. Delivery Mode - the motor slide displacement shall be within ±5% of the expected displacement (For examples: 0.0818975 inches is the expected displacement measured at 25.0 U/hr Basal rate in 1 hour). | Passed |
| FCC Testing | Demonstrate compatibility with FCC regulation | Emitted levels must be per FCC CFR 47 Part 15.247. It is acceptable that the pump pay lose RF communication with the transmitter. In this case the pump will alarm “Lost Sensor” to notify the user. Pump operating mode shall not be affected. BG Meter commanded bolus amount matches pump displayed delivered amount. No interruption of pump alarms, and no change in pump operating mode or programmed settings. | Passed |
| FAA Testing per RTCA DO-160G Section 20.5 Category R | Determines the ability of the NGP to withstand RF disturbances radiated by external sources | The NGP shall maintain Basic Safety. Cessation of delivery must be accompanied with an alarm Isig values recorded during exposure must be within the value | Passed |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 16
{16}
| Test | Purpose | Acceptance Criteria Summary | Pass/Fail |
| --- | --- | --- | --- |
| | | specified for the TUT or TPT (49.93 – 56.70 nA) Idle/Alarm Mode - total displacement is less than 0.00348759 inches Delivery Mode - the motor slide displacement shall be within ±5% of the expected displacement (For examples: 0.0818975 inches is the expected displacement measured at 25.0 U/hr Basal rate in 1 hour). | |
| MRI Immunity | Determines the ability of the NGP to maintain Basic Safety when exposed to electromagnetic fields which exceed the intended use environments | The NGP shall maintain Basic Safety. Cessation of delivery must be accompanied with an alarm. | Passed |
| Electromagnetic Disturbances | Determines the ability of the NGP to withstand radiated electromagnetic energy by external sources. | The NGP shall maintain Essential Performance during and after the exposure. Cessation of delivery must be accompanied with an alarm. Isig values recorded during exposure must be within the value specified for the TUT or TPT (49.93 – 56.70 nA) Idle/Alarm Mode - total displacement is less than 0.00348759 inches Delivery Mode - the motor slide displacement shall be within ±5% of the expected displacement (For examples: 0.0818975 inches is the expected displacement measured at 25.0 U/hr Basal rate in 1 hour). | Passed |
| RF Transmission | Verifies the NGP can receive radio frequency (RF) transmissions of sensor glucose (SG) from the Glucose Sensor Transmitter (GST). | The NGP BLE shall receive sensor glucose (SG) values from an associated GST | Passed |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 17
{17}
| Test | Purpose | Acceptance Criteria Summary | Pass/Fail |
| --- | --- | --- | --- |
| ESD Immunity | Verifies that the NGP can maintain Essential Performance in an environment with high level of electrostatic discharge (ESD) at ±22 kV and ±30 kV, with a low relative humidity of 1-5 %. | The NGP shall maintain Basic Safety. Cessation of delivery must be accompanied with an alarm. Isig values recorded during exposure must be within the value specified for the TUT or TPT (49.93 – 56.70 nA) | Passed |
| Security Device Immunity | Determines the ability of the NGP to withstand RF disturbances radiated by external sources such as Electronic Article Surveillance, RFID, metal detectors, and tag deactivators | The NGP shall maintain Basic Safety. Cessation of delivery must be accompanied with an alarm. Isig values recorded during exposure must be within the value specified for the TUT or TPT (49.93 – 56.70 nA) Idle/Alarm Mode - total displacement is less than 0.00348759 inches. Delivery Mode - the motor slide displacement shall be within ±5% of the expected displacement (For examples: 0.0818975 inches is the expected displacement measured at 25.0 U/hr Basal rate in 1 hour). | Passed |
### **Packaging**
The MiniMed 770G Pump was tested under conditions of simulated shipping per ASTM D4169, *Standard Practice for Performance Testing of Shipping Containers and Systems*. Testing included environmental conditioning, manual handling, vehicle stacking, loose load vibration, low pressure testing, vehicle vibration, concentrated impact, and final inspection of samples. The MiniMed 770G Insulin Pump (MMT-1880) has a shelf life of 1095 days (3 years) based on the internal backup battery, which requires regular recharging.
Please see the SSED for P160017 for descriptions of the pre-clinical testing of the Guardian Link (3) Transmitter and Guardian Sensor (3) packaging validation.
### **Software**
Comprehensive verification and validation testing was conducted to confirm that the software used in the MiniMed 770G System meets all specified requirements and that the software will operate reliably and safely under normal or abnormal use conditions.
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 18
{18}
The software verification and validation were carried out in accordance with the FDA Guidance Document, “General Principles of Software Validation: Final Guidance for Industry and FDA Staff.” 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. The pump has the capability to securely receive and install firmware over the air (FOTA) updates from an external server (which is not yet available). Verification of the FOTA functionality in the pump software is included in the supplement.
### **Human Factors Testing**
Human Factors usability validation studies were conducted in accordance with EN62366, Medical Devices – Application of Usability Engineering to Medical Devices and the FDA Guidance Document “Applying Human Factors and Usability Engineering to Medical Device: Guidance for Industry and Food and Drug Administration Staff”.
The sponsor previously conducted usability validation studies to evaluate use of the MiniMed 670G System by Type 1Diabetes Melitus (T1DM) patients ages 14 years and older (submitted under P160017) and by T1DM patients ages 7 to 13 years of age with assistance from an adult caregiver (submitted under P160017/S031).
The sponsor also conducted two usability validation studies to evaluate the MiniMed 670G System, with continuous glucose monitoring and auto mode (hybrid closed loop, or HCL) function, to provide evidence that caregivers of younger children (2 to 6 years of age) diagnosed with T1DM can safely and effectively use the MiniMed 670G System. These usability validation studies are applicable to the MiniMed 770G System because the user interface functions of both the 670G and 770G pumps are similar.
In the first study, users representing caregivers of both novice and experienced pediatric pump users participated performed critical tasks associated with using the MiniMed 670G system in both Manual and Auto Modes with the continuous glucose monitoring system. Task Analysis was used to determine critical tasks. The two user groups were defined as follows:
- ○ Novice Insulin Pump Users: Users in this group were not currently external pump users, had less than 6 months of experience with a Medtronic pump, or were currently using a competitor pump.
- ○ Experienced Insulin Pump Users: Users in this group currently were using a Medtronic external insulin pump for more than 6 months.
A second study was performed that focused only on novice pediatric pump users. 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 determine whether design changes would
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 19
{19}
further reduce the risks and to assess the residual risks related to the benefits to the patient. It was determined that no design changes were necessary. However, it was concluded that the current pump training program should be enhanced to address the usability issues identified in the human factors studies especially for novice pump users for this age group. The training program has been updated based on the findings from the human factors study. Some key areas that have been modified include the addition of proactive training measures to address user errors encountered during the human factors studies, new touchpoints to assure that user device training is scheduled with optional touch points to reinforce key concepts or training on items for patients that may need additional help, and a plan for validating training effectiveness in the post-market stage. Training is required for the use of the 770G System and a warning has been added to the device labeling to emphasize that users should not use the device until having received the appropriate training.
# **B. Animal Studies**
None
# **C. Additional Studies**
None
# **X. SUMMARY OF PRIMARY CLINICAL STUDY(IES)**
In addition to the clinical studies that established the safety and effectiveness of the MiniMed 670G System in users 7 years of age and older (see in the SSEDs for P160017 and P160017/S031), the sponsor performed clinical studies of the 670G System in pediatric subjects ages 2-6 years. These studies establish a reasonable assurance of the safety and effectiveness of the MiniMed 770G System because the underlying therapy in the 670G system, and the associated Guardian Sensor (3), are identical to that of the 770G System. Other changes to the device, which include the change of the communication protocol to BLE and the change of the blood glucose monitoring system component to the Accu-Check Guide Link Blood Glucose Monitoring System, do not impact the clinical study results. A summary of the clinical studies is presented below.
*Table 6: Summary of P160017/S076 Clinical Studies*
| Clinical Study | IDE | Patient Population | Study Design/Objective |
| --- | --- | --- | --- |
| Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects with Type 1 Diabetes | G150247 | 2-6 years* | Multi-center, single-arm, home and hotel clinical study. The study evaluated the safety of the 670G System and its algorithm with the Guardian Sensor in subjects aged 2 13 years. |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 20
{20}
| A Performance Evaluation of the Enlite® and Enlite 3 Glucose Sensor to Support Use in Children; Phase 2 (Enlite 3) | G120262 | 2-6 years* | Multi-center, prospective, single-sample correlational design without controls. The study demonstrated the measurement performance of the Guardian Sensor (3) (commercial name of Enlite 3) in subjects aged 2 to 18 years. |
| --- | --- | --- | --- |
*Note: These studies were designed for broader pediatric patient populations (2-13 years for G150247 and 2-18 years for G120262). However, only data for the patient population aged 2-6 years, from G150247 was provided in support of this PMA supplement. Therefore, data for the matching patient population from G120262 was reviewed. Only data for this 2-6-year-old population from both studies are presented in this SSED document.
# ***Pivotal study: Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects with Type 1 Diabetes (G150247):***
# **A. Study Design**
Subjects were treated between April 10, 2017 and November 28, 2018 and included 46 patients. There were 7 investigational sites.
The pivotal study was a multi-center, single-arm home and hotel clinical evaluation in subjects with type 1 diabetes on insulin pump therapy. The sponsor enrolled 52 subjects (ages 2-6 years) at 7 investigational centers (see subject accountability below).
Of the 52 subjects that enrolled, 47 entered the run-in period. One subject withdrew prior to the start of the study period. Therefore, 46 subjects entered the study period. The 46 study subjects wore the MiniMed 670G pump with the Guardian Link (3) Transmitter, the Guardian Sensor (3) and infusion sets for approximately 3.5 months and participated in all three study phases: a two-week run-in period, a three-month at-home use period, and an out-of-home study for 5 consecutive days occurring during the at-home use period. Subjects were instructed to use the device in Auto Mode for the duration of the 3-month at home study. One subject withdrew during the study period. Therefore, 45 subjects completed the study period.
# *Run-in period*
During the two-week run-in period, subjects used the study pump (670G) with only the sensor augmented pump function activated (all automated features were off).
Prior to wearing study devices, all subjects and their companions were trained on the devices as well as diabetes management principles, such as the treatment of hyperglycemia and hypoglycemia. In addition, there was training regarding the need to have access to oral glucose in case of hypoglycemia. Subjects were instructed to monitor blood glucose using self-monitoring of blood glucose (SMBG) 4-6 times a day. As a precaution, subjects were told that they should keep their own insulin pump
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 21
{21}
supplies in case they were asked during the study to revert back to using their own pump. Subjects were also instructed that they should always have insulin and syringes or pens, in case they encountered problems with the study pump (e.g., infusion set occlusion with high glucose).
#### *At-Home Study Period*
Following the two-week run-in period, a total of 46 subjects participated in a 3-month at-home study period. Prior to entry into Auto Mode, subjects used the pump in Manual Mode during the first 6 days of the study period in order to collect data on insulin utilization and sensor glucose levels. After this 6-day period, the subjects were allowed to enter Auto Mode.
Subjects were required to have a companion with them during the night for the duration of the study period. Companions, who had to be at least 18 years of age, were instructed to be under the same roof (i.e. within range and able to hear sensor alarms), but not necessarily in the same bedroom as the study subject. Subjects were also required to upload their pump data daily for the first 14 days after entering into Auto Mode to facilitate remote monitoring by the study sponsor.
The required device settings for the study are below unless otherwise stated as optional:
- • Manual Mode:
- ○ High Sensor Glucose Alert was recommended to be set at 300 mg/dL
- ○ Low Sensor Glucose Alert was recommended to be set at 80 mg/dL
- ○ Low Sensor Glucose Alert could not be set lower than 70 mg/dL
- ▪ It was recommended (optional) to have the *Suspend before Low* feature turned ON
- • Auto Mode:
- ○ Adjustable Sensor Glucose Settings
- ○ High alert was recommended to be set at 300 mg/dL
- ○ Low sensor glucose alert recommended was to be set at 80 mg/dL
- ▪ Low sensor glucose alert could not be set lower than 70 mg/dL
- • The Temp Target was recommended to be used when subject exercises
- • Alarms that were fixed (not able to be adjusted or turned OFF) in Auto Mode:
- ○ When sensor glucose is at or below 50 mg/dL
- ○ When sensor glucose is at or above 300 mg/dL for one hour
- ○ When sensor glucose is at or above 250 mg/dL for 3 hours
#### *Out-of-Home Study Period*
All 46 subjects participated in the out-of-home portion of the study period which lasted for 5 consecutive days, 4 – 6 hours per day. The purpose of the out-of-home portion of the study was to stress the system with sustained daily exercise.
During the out-of-home study, subjects engaged in significant activity/exercise, including use of gym play areas appropriate for toddlers and young children,
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 22
{22}
swimming, and playground games. Subjects underwent 4 – 6 hours of daytime frequent sample testing on one of the days of the out-of-home study period, with sampling occurring every 30 minutes. With respect to meals, subjects were allowed to eat as they normally would at home.
The study was a multi-center, single arm observational at home and hotel clinical study with no controls. There were no statistically powered endpoints in the Auto Mode study (G150247). This was a descriptive study to evaluate the safe use of the 670G System.
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 2 – 6 years at time of screening
2. Subject age 2 – 6 years has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Study-Specific Inclusion Criteria
3. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
4. Subject 2-6 years of age and their parent(s)/guardian(s) are willing to participate in an extended visit during the study period to perform Frequent Sample Testing.
5. Subject must have companion 18 years or older who will sleep in the same dwelling place every night during the Study period. This requirement may be verified by subject report at screening visit.
6. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
7. Subject is willing to perform required sensor calibrations
8. Subject is willing to wear the system continuously throughout the study
9. Subject has a Glycosylated hemoglobin (HbA1c) value less than 10.0% (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.
10. Subject has thyroid stimulating hormone (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.
11. Subject 2-6 years of age has had pump therapy for greater than 90 days prior to screening (with or without CGM experience)
12. Subjects and their parent(s)/guardian(s) are 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
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 23
{23}
13. If subject has celiac disease, it has been adequately treated as determined by the investigator
14. Subjects and their parent(s)/guardian(s) are 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)
o Humalog® (insulin lispro injection)
o NovoLog® (insulin aspart)
15. Subjects and their parent(s)/guardian(s)/companions must be able to speak and be literate in English as verified by the investigator
Subjects were not permitted to enroll in the pivotal study if they met any of the following exclusion criteria:
1. Subject has a history of 2 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 is unable to tolerate tape adhesive in the area of sensor placement
3. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
4. 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.
5. Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
6. Subject is being treated for hyperthyroidism at time of screening
7. Subject has diagnosis of adrenal insufficiency
8. Subject 2-6 years of age has had DKA in the 3 months prior to screening visit.
9. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
10. 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
Subject 2-6 years of age has been hospitalized or has visited the ER in the 3 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
11. Subject is currently abusing illicit drugs
12. Subject is currently abusing marijuana.
13. Subject is currently abusing prescription drugs
14. Subject is currently abusing alcohol
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 24
{24}
15. 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
16. 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
17. Subject has elective surgery planned that requires general anesthesia during the course of the study
18. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
19. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
20. Subject diagnosed with current eating disorder such as anorexia or bulimia
21. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
22. Subject has a hematocrit that is below the normal reference range of lab used.
23. Subject is on dialysis
24. Subject has serum creatinine of >2 mg/ dL.
## 2. Follow-up Schedule
Throughout the study period there were a number of scheduled telephone calls. These calls were meant to make sure that the subject was healthy and to remind them about adherence to study requirements, for example uploading the study pump data to CareLink.
During the final study visit, subjects were asked to complete some questionnaires about their experience and also had blood collected for an HbA1c test.
### Out-of-Home Study Phase
A staff member who was a healthcare professional supervised subjects during the 4-6 hours of each day of the out-of-home study phase.
### 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 Auto Mode.
### Descriptive Endpoints
- The mean change in HbA1c is presented from baseline to end of study
- Change of Total Daily Dose (TDD) of insulin from baseline to end of study
- Change of weight from baseline to end of study
- Time spent in Auto Mode versus time spent in Manual Mode
- Time in different range (% of sensor glucose): sensor glucose ≤ 50 mg/dL, ≤ 54 mg/dL, ≤60 mg/dL, ≤ 70 mg/dL, 71 mg/dL – ≤180
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 25
{25}
mg/dL, sensor glucose > 180 mg/dL, > 250 mg/dL, > 350 mg/dL
- Number of Events, AUC and Time in the hyperglycemic range: sensor glucose (SG) > 180 mg/dL, > 250 mg/dL, > 350 mg/dL
- Number of Events, AUC and Time in the hypoglycemic range: sensor glucose ≤ 50 mg/dL, ≤ 54 mg/dL, ≤ 60 mg/dL, and ≤ 70 mg/dL
# Safety Data Summarized
- Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE)
- Unanticipated Adverse Device Effects (UADE)
- Incidence of Severe Hypoglycemia
- Incidence of DKA
# B. Accountability of PMA Cohort
A total of 47 subjects entered the run-in period, 1 subject withdrew during the run-in period and 46 subjects entered the study period. One subject withdrew during the study period, therefore 45 subjects completed the study period.
The demographics of the study population are typical for studies performed in the Type 1 diabetes population performed in the US.
# C. Study Population Demographics and Baseline Parameters
The demographics of the study population are typical for studies performed in the Type 1 diabetes population performed in the US.
Table 7: Study Demographics
| Characteristic | Number of Subjects = 46 |
| --- | --- |
| **Age (Years)** | |
| n | 46 |
| Mean (SD) | 4.6 (1.4) |
| Median | 5.0 |
| Min, Max | 2.0, 6.0 |
| **Gender N(%)** | |
| Female | 20 (43.5%) |
| Male | 26 (56.5%) |
| **Race N(%)** | |
| American Indian/Alaska Native | 1 (2.2%) |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 26
{26}
| Characteristic | Number of Subjects = 46 |
| --- | --- |
| Black/African American | 4 (8.7%) |
| Other | 3 (6.5%) |
| White | 38 (82.6%) |
| **Ethnicity N(%)** | |
| Hispanic/Latino | 5 (10.9%) |
| Non-Hispanic/Non-Latino | 41 (89.1%) |
| **Diabetes History(Years)** | |
| n | 46 |
| Mean (SD) | 2.9 (1.4) |
| Median | 2.5 |
| Min, Max | 0.8, 5.5 |
| **Height(cm)** | |
| n | 46 |
| Mean (SD) | 110.7 (10.6) |
| Median | 111.8 |
| Min, Max | 86.0, 130.7 |
| **Weight (kg)** | |
| n | 46 |
| Mean (SD) | 20.6 (4.0) |
| Median | 20.3 |
| Min, Max | 11.3, 28.2 |
| **BMI (kg/m^{2})** | |
| n | 46 |
| Mean (SD) | 16.7 (1.7) |
| Median | 16.0 |
| Min, Max | 14.0, 22.0 |
| **Baseline HbA1c (%)** | |
| n | 46 |
| Mean (SD) | 8.0 (0.9) |
| Median | 8.1 |
| Min, Max | 6.0, 9.9 |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 27
{27}
# D. Safety and Effectiveness Results
# 1. Safety Results
The safety of the 670G System was assessed by evaluation of the incidence of all serious Adverse Events, Adverse Device Effects (ADEs), Serious Adverse Device Events (SADEs), and Unanticipated Adverse Device Effects (UADEs) experienced by study subjects. Adverse events (AEs) were listed in terms of severity and relationship to the device.
There was one report of a serious adverse event. This event was an episode of altered mental status after a fall that occurred prior to the subject beginning use of the 670G system and therefore the event was adjudicated as 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/procedural effects.
There were no reports of diabetic ketoacidosis events.
There were no reports of severe hypoglycemia events.
There were 86 severe hyperglycemia events reported.
Severe hyperglycemia was defined in the protocol as a glucose concentration >300 mg/dL with blood ketones >0.6mmol/L or accompanied by symptoms of nausea, vomiting or abdominal pain.
Of the 86 reported severe hyperglycemia events, 49 were thought to be device-related. The majority (39) of the device-related severe hyperglycemia events were believed to be due to infusion set issues (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 were no reports of severe hypoglycemia events.
# 2. Effectiveness Results
The data below describe how the device performed during the HCL pivotal study. The study was not designed to determine the effectiveness of the device compared
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 28
{28}
to alternative treatments such as manual daily injections or non-automated insulin pump therapy.
The table below provides an overall summary of the run-in phase and study phase (home and hotel) for all subjects in the study. The data presented in this table includes information about subjects' glucose levels, insulin delivered and weight during run-in versus study phases.
*Table 8: Percent of Time within Glucose Ranges, Mean Insulin Delivery, and Mean Weight of Subjects during Run-in and Study Phases*
| Parameter | Age 2-6 Years (46) | |
| --- | --- | --- |
| | Run-In | Study |
| Sensor glucose, mean ± SD (median, interquartile range) mg/dL | 172.8±24.5 (172.8, 157.1-191.8) | 161.2±16.2 (161.5, 148.5-171.1) |
| Sensor Glucose Range (mg/dL) | Percent of Time with Glucose Level in Range Mean ± SD (95% CI), % | |
| ≤ 50 mg/dL | 0.5±0.6 (0.3, 0.7) | 0.5±0.4 (0.4, 0.6) |
| ≤ 54 mg/dL | 0.8±0.8 (0.6, 1.1) | 0.8±0.6 (0.6, 1.0) |
| ≤ 60 mg/dL | 1.6±1.4 (1.1, 2.0) | 1.5±0.9 (1.2, 1.8) |
| ≤ 70 mg/dL | 3.6±2.6 (2.8, 4.4) | 3.5±1.6 (3.0, 3.9) |
| 71 – ≤ 180 mg/dL | 55.4±13.3 (51.4, 59.3) | 63.6±9.4 (60.8, 66.4) |
| > 180 mg/dL | 41.0±14.7 (36.7, 45.4) | 33.0±9.9 (30.0, 35.9) |
| > 250 mg/dL | 14.6±9.4 (11.8, 17.4) | 10.7±5.9 (8.9, 12.4) |
| > 300 mg/dL | 5.2±4.9 (3.7, 6.7) | 3.7±2.9 (2.9, 4.6) |
| > 350 mg/dL | 1.7±2.1 (1.0, 2.3) | 1.2±1.1 (0.8, 1.5) |
| Within-day SD of glucose – mean ± SD (median, interquartile range) mg/dL | 58.4±9.7 (59.3, 52.3-65.0) | 57.0±8.5 (57.8, 49.8-61.9) |
| Within-day coefficient of variation of glucose (%) – mean ± SD (median, interquartile range) mg/dL | 34.2±3.6 (34.1, 31.2-36.7) | 35.3±2.6 (34.7, 33.2-37.8) |
| Glycated hemoglobin – mean ± SD (median, interquartile range), % | 8.0±0.9 (8.1, 7.3-8.7) | 7.5±0.6 (7.5, 7.1-7.9) |
| Total daily dose of insulin – mean ± SD (median, interquartile range), U | 15.4±4.0 (15.6, 12.4-17.7) | 16.1±4.7 (16.4, 12.5-18.3) |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 29
{29}
| Parameter | Age 2-6 Years (46) | |
| --- | --- | --- |
| | Run-In | Study |
| Total daily dose/Weight – mean ± SD (median, interquartile range), U/kg/day | 0.8±0.1 (0.8, 0.7-0.8) | 0.8±0.2 (0.7, 0.6-0.9) |
| Basal insulin as a % of total daily insulin – mean ± SD (median, interquartile range) | 41.6±10.1 (42.2, 33.4-47.8) | 39.8±10.7 (40.6, 35.4-46.7) |
| Weight – mean ± SD (median, interquartile range), kg | 20.6±4.0 (20.3, 17.7-23.4) | 21.3±4.0 (21.4, 18.0-24.4) |
The subjects' baseline HbA1c value was collected at the first office visit during the study period. The end-of-study HbA1c was collected at the last visit of the study period. The change in mean HbA1c from the first visit and last visit was analyzed and found to be -0.5% (with 95% confidence intervals of -0.7 to -0.3). A summary of HbA1c data is provided in the table below.
*Table 9: Percent Change in HbA1c from Baseline to End of Study*
| | Baseline (SD) | End of Study (SD) | Change from Baseline to End of Study (SD) |
| --- | --- | --- | --- |
| Number of Subjects | 46 | 44* | 44* |
| HbA1c, %, Mean (SD) | 8.0 (0.9) | 7.5 (0.6) | -0.5 (0.7) |
| HbA1c %, Median | 8.1 | 7.5 | -0.5 |
| 95% Confidence Interval | (7.7, 8.2) | (7.4, 7.7) | (-0.7, -0.3) |
| HbA1c, %, Min, Max | 6.0, 9.9 | 6.2, 8.8 | -1.6, 1.0 |
* The end-of-study A1c for Subject 302007001 was not collected and the deviation was reported. The end-of-study A1c for Subject 302008001 was not collected due to early withdrawal, per protocol.
The table below provides data regarding the subject baseline HbA1c collected at the beginning of the study and the number of subjects who experienced a decrease, no change, or increase in HbA1c values at the end of the study.
*Table 10: Number of subjects with change in HbA1C at different baselines*
| HbA1c Change Range (%) | Number (%) of Subjects with Change in HbA1c | | | | |
| --- | --- | --- | --- | --- | --- |
| | Decrease > 1% | Decrease > 0 to 1% | No Change | Increase > 0 to 1% | Increase > 1% |
| 5% ≤ HbA1c <6%* | - | - | - | - | - |
| 6% ≤ HbA1c <7% | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 6 (13.0%) | 0 (0.0%) |
| 7% ≤ HbA1c <8% | 2 (4.3%) | 7 (15.2%) | 0 (0.0%) | 4 (8.7%) | 0 (0.0%) |
| 8% ≤ HbA1c <9% | 4 (8.7%) | 11 (23.9%) | 1 (2.2%) | 2 (4.3%) | 0 (0.0%) |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 30
{30}
| 9% ≤ HbA1c < 10% | 5 (10.9%) | 2 (4.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| --- | --- | --- | --- | --- | --- |
| **Overall** | 11 (23.9%) | 20 (43.5%) | 1 (2.2%) | 12 (26.1%) | 0 (0.0%) |
The table below provides the average time the subjects spent in a specific glucose range in both the run-in and study phases.
Table 11: Time spent in specific glucose ranges during the run-in and study phases by all subjects
| Glucose Range (mg/dL) | Run-In Time in Glucose Range (mins) Mean ± SD (Median, Interquartile Range) | Study Time in Glucose Range (mins) Mean ± SD (Median, Interquartile Range) |
| --- | --- | --- |
| **≤50** | 7.5±8.8 (5.8, 1.6-9.6) | 7.4±6.5 (5.1, 3.3-9.2) |
| **≤60** | 22.4±20.2 (17.0, 8.5-30.2) | 21.4±13.6 (16.9, 13.4-23.9) |
| **≤70** | 51.9±37.7 (50.0, 26.8-61.7) | 49.7±23.7 (42.7, 33.0-57.0) |
| **>70 to 180** | 797.6±191.6 (796.1, 659.5-890.0) | 915.5±134.8 (886.7, 833.3-1038.4) |
| **>180** | 590.5±211.1 (607.1, 455.2-742.1) | 474.8±142.6 (483.1, 360.4-574.4) |
| **>250** | 210.6±136.0 (182.9, 104.3-304.0) | 153.5±85.4 (160.9, 77.1-204.1) |
| **>300** | 75.0±70.8 (49.5, 22.1-107.6) | 53.5±41.2 (45.7, 17.4-77.2) |
| **>350** | 23.9±30.8 (12.8, 2.6-33.7) | 16.6±16.4 (11.0, 2.9-27.2) |
The table below provides the average time subjects spent in a specific glucose range while in Auto Mode during the study phase.
Table 12: Time spent in auto mode at different glucose ranges during the study phase
| CGM Glucose Range (mg/dL) | Study Period Time in Glucose Range (mins) Mean ± SD (95% CI) |
| --- | --- |
| **≤50** | 6.2±5.4 (4.6, 7.8) |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 31
{31}
| CGM Glucose Range (mg/dL) | Study Period Time in Glucose Range (mins) Mean ± SD (95% CI) |
| --- | --- |
| ≤60 | 18.1±11.4 (14.7, 21.4) |
| ≤70 | 42.4±19.8 (36.5, 48.3) |
| >70 to 180 | 805.1±139.8 (763.6, 846.6) |
| >180 | 371.9±106.1 (340.4, 403.4) |
| >250 | 107.7±56.5 (90.9, 124.4) |
| >300 | 32.3±23.9 (25.2, 39.3) |
| >350 | 7.7±7.5 (5.5, 9.9) |
| All | 1219.4±93.0 (1191.8, 1247.0) |
The table below summarizes time spent in Auto Mode and summary of sensor wear, from start of Auto-Mode (Day 7 of the Study Phase) until the end of the study period.
*Table 13: Summary of Sensor Wear and Time Spent in Auto Mode, From Start of Auto-Mode to End of the Study Period*
| Category | Percentage of Time |
| --- | --- |
| Time spent wearing sensor | 96.2% |
| Time spent not wearing sensor | 3.8% |
| Auto Mode (core algorithm) | 77.8% |
| Auto Mode (safe basal) | 7.1% |
| Time spent in Manual Mode | 15.1% |
# **Guardian Sensor Performance Study - A Performance Evaluation of the Enlite® and Enlite 3 Glucose Sensor to Support Use in Children; Phase 2 (Enlite 3) (G120262):**
# **A. Study Design**
This study was performed to assess the analytical performance of the Guardian
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 32
{32}
Sensor (3). It ran between May 12, 2015 and December 13, 2016 and included 21 subjects (different from subjects who participated in the pivotal study above). There were 11 investigational sites.
This study was a prospective, single arm, multi-center, in-clinic study. All subjects wore one receiver, one transmitter, one transmitter used as a recorder, and two sensors. All subjects were assigned to complete frequent sample testing (FST).
Subjects wore the Guardian Sensor (3) for a 7-day training period (that included a minimum of 6 days of sensor wear), followed by a 7-day study period. During the study period, each subject participated in one in-clinic FST intervention. FST occurred at the beginning (Day 1), middle (Day 3) or end (Day 7) of the Guardian sensor (3) use. During these FST sessions, if tolerated by the patient, intravenous (IV) blood samples were drawn every 5 to 15 minutes and analyzed for plasma blood glucose levels using the comparator method (CM); otherwise, blood glucose levels were measured using a blood glucose meter at the same time intervals. The CM in this study was the Yellow Springs Instrument (YSI) 2300 Stat Plus Glucose Lactate Analyzer or the Bayer CONTOUR Next Link RF blood glucose meter. FST with the CM lasted approximately 6 hours during the in-clinic visit.
Subjects were randomized to one of 10 groups that determined when they participated in the in-clinic FST.
Subjects continued with their current diabetes regimen independent of the study devices. Subjects were instructed by the investigational center that they were not to use the investigational devices for the management of their diabetes.
There was no control group as this study was an observational study to determine the accuracy and precision of the Guardian sensor. Accuracy was assessed by comparing the sensor values to the CM, and precision of the sensor system was assessed by comparing sensor values to each other in subjects wearing two sensors.
1. Clinical Inclusion and Exclusion Criteria
Enrollment in the Guardian sensor study was limited to subjects who met the following inclusion criteria:
1. Subject is 2-6 years of age at time of screening (which was a subset of the entire study population)
2. Subject has been diagnosed with insulin requiring diabetes mellitus for at least one year.
3. Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily
4. Subject is willing to perform required sensor calibrations
5. Subject is willing to wear the system continuously throughout the study
Inclusion Criteria Specific to Study
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 33
{33}
6. Adequate venous access for subjects requiring IV for their FST, as assessed by investigator or appropriate staff
Subjects were not permitted to enroll in the Guardian sensor study if they met any of the following exclusion criteria:
1. Subject is unable to tolerate tape adhesive in the area of sensor placement
2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subjects with hematocrit lower than the normal age specific reference range per central or local lab testing
# 2. Follow-up Schedule
At the end of the study, subjects removed all study devices. Upon removal, all the Sensor insertion sites were examined and evaluated by the study staff. Sensors were visually inspected at the site. Study investigators documented any Adverse Device Effects (including skin irritations) and evaluated safety issues related to system use during the study. No long-term follow up was included in this study protocol.
# 3. Clinical Endpoints
Because this was an observational study, it did not include traditional analysis of clinical endpoints. The data were presented using multiple analyses as described in the Study Results section below.
Safety of the sensor was determined by skin and insertion site reactions.
# B. Accountability of Study Cohort
Of the 21 subjects that entered the study, all participated in Phase 2 (Enlite 3 Phase) of the study. No subjects withdrew before entering Phase 2 (Enlite 3 phase).
All 21 subjects underwent FST and completed the study. Six (6) subjects completed the first FST on Day 1, 7 subjects completed FST on Day 3, and 8 subjects completed FST on Day 7.
# C. Study Population Demographics and Baseline Parameters
Table 14: Study Demographics
| Characteristic | All Subjects N = 21 |
| --- | --- |
| Age (Years) | |
PMA Supplement P160017/S076: FDA Summary of Safety and Effectiveness Data
Page 34
{34}
| Characteristic | All Subjects N = 21 |
| --- | --- |
| Number of Subjects | 21 |
| Mean (SD) | 5.3 (0.90) |
| Median | 6 |
| Min, Max | 3.0, 6.0 |
| **Gender, Number (%)** | |
| Female not of child beari…
