SmartAdjust(TM) technology

K220394 · Insulet Corporation · QJI · Aug 19, 2022 · Clinical Chemistry

Device Facts

• Record ID: K220394
• Device Name: SmartAdjust(TM) technology
• Applicant: Insulet Corporation
• Product Code: QJI · Clinical Chemistry
• Decision Date: Aug 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Intended Use

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

Device Story

Software-only medical device (iAGC) part of Omnipod 5 Automated Insulin Delivery System; resides on Omnipod 5 ACE Pump and App. Inputs: real-time glucose data from compatible iCGM (Dexcom G6) via Bluetooth Low Energy; user-defined parameters. Operation: algorithm calculates insulin delivery every 5 minutes; adjusts basal insulin based on current/predicted glucose trends; supports Automated, Automated: Limited, and Activity modes. Output: automated insulin delivery commands to ACE pump. Used in home/outpatient settings by patients/caregivers. Healthcare providers use output to monitor glycemic control. Benefits: improved time-in-range, reduced HbA1c, and automated glycemic management.

Clinical Evidence

Prospective, single-arm, multi-center study of 80 subjects (aged 2.0-5.9 years). Compared 14-day standard therapy to 13-week hybrid closed-loop (HCL) phase. Primary endpoints: change in time-in-range (70-180 mg/dL) and HbA1c. Results: Time-in-range increased from 57.2% to 68.1% (change 10.9%); HbA1c decreased (baseline <8% group: -0.31%; baseline ≥8% group: -1.06%). No deaths, serious adverse events, or UADEs reported.

Technological Characteristics

Software-only iAGC; resides on Omnipod 5 ACE Pump and App. Connectivity: Bluetooth Low Energy for iCGM data transmission. Algorithm: automated glycemic control (closed-loop) with user-customizable glucose targets (110–150 mg/dL). Sterilization: N/A (software).

Indications for Use

Indicated for management of type 1 diabetes mellitus in persons 2 years of age and older. Contraindicated for those under 2 years old, those requiring <5 units of insulin/day, pregnant women, critically ill patients, patients on dialysis, and those taking hydroxyurea. Requires adequate hearing/vision for alerts.

Regulatory Classification

Identification

An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect ( *e.g.,* more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events. (ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices. (iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to ( *e.g.,* specification of glucose sensor performance) or accept commands from (*e.g.,* specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices. (vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( *e.g.,* validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller. (2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following: (i) Risk control measures to address device system hazards; (ii) Design decisions related to how the risk control measures impact essential performance; and (iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. (3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to connected devices; (ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices; (iii) Sharing of necessary state information between the controller and any connected devices ( *e.g.,* battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified; (v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and (vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance. (4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include: (i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices; (ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices ( *e.g.,* infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and (iv) Connectivity events ( *e.g.,* establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section. (6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section. (7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable. (8) The labeling required under § 809.10(b) of this chapter must include: (i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part. (ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe. (iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate. (iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section. (v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate. (vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section. (vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.

Predicate Devices

• SmartAdjust technology (K203774)

Reference Devices

• Omnipod 5 ACE Pump (K203768)
• Omnipod 5 Bolus Calculator (K203772)
• Dexcom G6 iCGM (K201328)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K220394

B Applicant

Insulet Corporation

C Proprietary and Established Names

SmartAdjust™ technology

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QJI | Class II | 21 CFR 862.1356 - Interoperable Automated Glycemic Controller | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to a cleared device to expand the age indication (from ≥6 years old to ≥2 years old).

B Type of Test:

Not applicable.

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

SmartAdjust™ technology should not be used by anyone under the age of 2 years old.

SmartAdjust™ technology should also NOT be used in people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population.

Do not use SmartAdjust™ technology in pregnant women, critically ill patients, and those on dialysis. The safety of the SmartAdjust™ technology has not been evaluated in these populations.

Do not use SmartAdjust™ technology if you are taking hydroxyurea as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycemia.

Do not use SmartAdjust™ technology if you do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders.

SmartAdjust™ technology used with the Omnipod 5 System is designed to use rapid-acting U-100 insulins. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoLog® (insulin aspart), Humalog® (insulin lispro), and Admelog® (insulin lispro) for use up to 72 hours (3 days). Before using a different insulin with the Omnipod 5 System, check the insulin drug label and consult your healthcare provider. Refer to the insulin labeling and follow your healthcare provider's directions for how often to replace the Pod.

SmartAdjust™ technology used with the Omnipod 5 System relies on accurate, current CGM values to determine your insulin needs. Always make sure you are using the CGM per manufacturer's instructions and do not extend the sensor wear beyond the recommended duration.

Do NOT attempt to use the SmartAdjust™ technology with the Omnipod 5 System before you receive training. Inadequate training could put your health and safety at risk.

Device components used with the SmartAdjust™ technology including the pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomoraphy (CT) scan, or diathermy treatment. In addition, the SmartAdjust™

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Controller and smartphone should be placed outside of the precedence room. Exposure to MRI, CT, or diathery treatment can damage the components.

At the time of device authorization, the compatible integrated continuous glucose monitor (iCGM) is the Dexcom G6 iCGM.

## IV Device/System Characteristics:

### A Device Description:

SmartAdjust™ technology (the Omnipod 5 interoperable automated glycemic controller, or iAGC) is a software-only medical device intended for the management of type 1 diabetes mellitus. The Omnipod 5 iAGC uses data from a connected iCGM along with user-defined parameters to predict future glucose trends and automatically increase, decrease, or pause the delivery of insulin via a compatible alternate controller enabled (ACE) pump.

The SmartAdjust™ technology software is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump (K203768), Omnipod 5 Bolus Calculator (K203772), and an integrated continuous glucose monitor (iCGM, Dexcom G6, most recently cleared under K201328). The SmartAdjust™ technology is intended to be digitally connected to an iCGM and an ACE Pump.

The SmartAdjust™ technology software resides on the Omnipod 5 ACE Pump (the Omnipod 5 Pod and Omnipod 5 App). The iAGC software is responsible for controlling insulin delivery via compatible ACE Pump when the system is in Automated Mode. iCGM data is transmitted from the iCGM to the ACE Pump via Bluetooth Low Energy technology. The SmartAdjust™ Technology uses this transmitted iCGM data in its calculations. The SmartAdjust™ technology can be turned off, and the Omnipod 5 ACE Pump will operate in Manual Mode, which delivers insulin based on healthcare provider (HCP) or user-defined basal programs.

The SmartAdjust™ technology has three states of operation: Automated Mode, Automated: Limited, and Activity. In Automated Mode, the system calculates insulin delivery every 5 minutes based on the user-customizable glucose target (110–150 mg/dL). Automated: Limited is enabled when the SmartAdjust™ technology is not receiving data from a connected iCGM for 20 minutes or more and during sensor warm-up. While in Automated: Limited, the user will receive no more than pre-programmed basal insulin. When a valid glucose value is received from the iCGM, the SmartAdjust™ technology will resume delivery of insulin in full Automated Mode. Activity is a temporary mode which the user may select for various time durations during automated mode up to 24 hours. With Activity, the algorithm reduces insulin delivery and sets a temporary glucose target to 150 mg/dL. Activity is intended for use during periods when insulin sensitivity is expected to be higher, such as during exercise.

### B Instrument Description Information:

1. Instrument Name:

SmartAdjust™ technology

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2. Specimen Identification:

Not applicable.

3. Specimen Sampling and Handling:

Not applicable.

4. Calibration:

Not applicable.

5. Quality Control:

Not applicable.

V Substantial Equivalence Information:

A Predicate Device Name(s):

SmartAdjust technology

B Predicate 510(k) Number(s):

K203774

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K220394 | K203774 |
| --- | --- | --- |
| Device Trade Name | SmartAdjust™ technology | SmartAdjust technology |
| General Device Characteristic Similarities | | |
| Indications for Use | SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus. SmartAdjust™ technology is intended for single patient use and requires a prescription. | Same |

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| Device & Predicate Device(s): | K220394 | K203774 |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| User Age | Ages 2 and older | Ages 6 and older |

VI Standards/Guidance Documents Referenced:

- FDA Guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated October 25, 2017
- FDA Guidance “Deciding When to Submit a 510(k) for a Software Change to an Existing Device” dated October 25, 2017
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016
- ANSI AAMI IEC 62366-1:2015 – Medical Devices – Part 1: Application of Usability Engineering
- ANSI AAMI HE75:2009/(R)2018 – Human Factors Engineering – Design of Medical Devices
- ANSI AAMI ISO 14971:2019 – Medical devices – Application of Risk Management to Medical Devices

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

The SmartAdjust™ technology is a software-only device, therefore the following analytical performance characteristics are not applicable.

1. Precision/Reproducibility:
Not applicable.

2. Linearity:
Not applicable.

3. Analytical Specificity/Interference:
Not applicable.

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4. Accuracy (Instrument):

Not applicable.

5. Carry-Over:

Not applicable.

## B Other Supportive Instrument Performance Characteristics Data:

1. Clinical Testing:

### Omnipod 5 Automated Insulin Delivery System Pivotal Study: Preschool Cohort

This study evaluated the safety and effectiveness of the Omnipod 5 System, including the SmartAdjust™ technology and SmartBolus Calculator, while in Automated Mode (closed-loop). This was a single-arm, multi-center, prospective clinical study that enrolled 80 subjects aged 2.0-5.9 years with type 1 diabetes across 10 clinical sites.

The study was conducted in three outpatient phases. Phase 1 consisted of a 14-day standard therapy phase followed by Phase 2 which consisted of a 13-week hybrid closed-loop phase. Phase 3 is the extension phase and is currently ongoing.

| Study Feature | Description |
| --- | --- |
| Title | Evaluating the safety and effectiveness of the Omnipod Horizon™ (Omnipod 5) Automated Glucose Control System in children with type 1 diabetes aged 2.0-5.9 years: preschool cohort |
| Study Design | Single-arm, multi-center, prospective clinical study |
| Number of Sites | Ten (10) US clinical sites |
| Population | 80 subjects aged 2.0-5.9 years with type 1 diabetes
Key Inclusion Criteria
• Age 2-5.9 years old
• Diagnosed with type 1 diabetes
• A1C < 10% at screening visit
Key Exclusion Criteria
• Use of non-insulin anti-diabetic medication other than metformin |
| Sample Size | 80 subjects were enrolled and completed the study |
| Protocol Overview/Synopsis | The study consisted of three outpatient phases:
• Phase 1: 14-day standard therapy (ST) phase
• Phase 2: 13-week hybrid closed-loop (HCL) phase
• Phase 3 is currently ongoing and consists of a hybrid closed-loop extension and was not reported in this submission. |

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Current and non-Dexcom G6 iCGM users who did not meet the minimum CGM data requirements participated in Phase 1 (where subjects managed their diabetes at home per their usual routine and remained on their current MDI or pump therapy, and sensor, if applicable). After completion of the standard therapy phase, subjects were trained on the system and transitioned to Phase 2 initiating treatment with the Omnipod 5 System. A subset of subjects participated in prescribed challenges during any consecutive 2-day period during Phase 2. Subjects who completed Phase 2 could commence their participation in Phase 3.

Participant baseline characteristics including demographics at enrollment:

| Characteristic | Enrolled |
| --- | --- |
| Age (years) ± SD | 4.7 ± 1.0 |
| Height (cm) ± SD | 108.4 ± 8.7 |
| Weight (kg) ± SD | 19.7 ± 3.3 |
| BMI (kg/m²) ± SD | 16.7 ± 1.5 |
| A1C* (%) ± SD | 7.4 ± 1.0 |
| Duration of diabetes (years) ± SD | 2.3 ± 1.1 |
| Previous or current pump use | 68/80 (85.0%) |
| Previous sensor use | 78/80 (97.5%) |
| Gender | |
| Female | 46/80 (57.5%) |
| Male | 34/80 (42.5%) |
| Race (not mutually exclusive) | |
| American Indian or Alaska Native | 0/80 (0.0%) |
| Asian | 5/80 (6.3%) |
| Black or African American | 7/80 (8.8%) |
| Native Hawaiian or Other Pacific Islander | 0/80 (0.0%) |
| White | 72/80 (90.0%) |
| Other | 1/80 (1.3%) |
| Ethnicity | |
| Hispanic or Latino | 7/80 (8.8%) |
| Not Hispanic or Latino | 73/80 (91.3%) |

± values are average ± standard deviation (SD); results reported with number in parentheses afterwards represents number of subjects (% of subjects)
*: Point of care A1C used to determine subjects' eligibility for the study.

## Pivotal Study Safety Results:

In the 80 subjects enrolled in the preschool cohort of 2.0-5.9 years, there were zero (0) deaths reported. There were zero (0) serious adverse events and zero (0) unanticipated adverse device effects (UADE) reported during Phase 2 of the study. A total of 29 non-serious adverse events were reported in Phase 2 of HCL in 21 participants, with 20 events classified as prolonged hyperglycemia, 4 events classified as hyperglycemia, and 5 events classified as other.

## Pivotal Study Observed Results:

The tables below include information on the primary and secondary glycemic results from the standard therapy phase compared to the 3-month OmniPod 5 System treatment phase. The

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primary results of the study included change in time in range (70-180 mg/dL) and average HbA1c%.

CGM Results Overall

| Characteristic | Standard Therapy | OmniPod 5 | Change* |
| --- | --- | --- | --- |
| Average % time 70-180 mg/dL (SD) | 57.2 (15.3) | 68.1 (9.0) | 10.9 (9.6) |
| Average sensor glucose, mg/dL (SD) | 171.1 (30.5) | 157.4 (16.8) | -13.7 (19.9) |
| Average standard deviation of sensor glucose, mg/dL (SD) | 64.9 (13.4) | 59.6 (10.3) | -5.3 (8.0) |
| Average coefficient of variation of sensor glucose, % (SD) | 38.1 (5.5) | 37.7 (4.0) | -0.4 (4.2) |
| Median % time <54 mg/dL (Q1, Q3) | 0.24 (0.05, 0.84) | 0.26 (0.16, 0.60) | 0.06 (-0.30, 0.16) |
| Median % time <70 mg/dL (Q1, Q3) | 2.19 (0.89, 4.68) | 1.94 (1.18, 3.43) | -0.27 (-1.54, 0.46) |
| Average % time >180 mg/dL (SD) | 39.4 (16.7) | 29.5 (9.8) | -9.9 (10.5) |
| Average % time ≥250 mg/dL (SD) | 14.8 (12.1) | 9.2 (5.6) | -5.6 (8.9) |
| Average % time ≥300 mg/dL (SD) | 6.0 (7.3) | 3.2 (2.8) | -2.7 (6.1) |

*Change is calculated as per-subject time in range during HCL phase minus per-subject time in range during ST.
SD=standard deviation, Q1=interquartile range 1, Q3=interquartile range 3

CGM Results Overnight (12:00 AM to 6:00 AM)

| Characteristic | Standard Therapy | OmniPod 5 | Change |
| --- | --- | --- | --- |
| Average % time 70-180 mg/dL (SD) | 58.2 (18.7) | 81.0 (10.0) | 22.8 (14.8) |
| Average sensor glucose, mg/dL (SD) | 168.1 (33.3) | 140.7 (16.4) | -27.4 (25.4) |
| Average standard deviation of sensor glucose, mg/dL (SD) | 58.0 (14.0) | 45.5 (10.8) | -12.5 (11.5) |
| Average coefficient of variation of sensor glucose, % (SD) | 34.7 (6.6) | 32.1 (5.2) | -2.6 (6.7) |
| Median % time <54 mg/dL (Q1, Q3) | 0.00 (0.00, 0.97) | 0.18 (0.06, 0.53) | 0.00 (-0.51, 0.13) |
| Median % time <70 mg/dL (Q1, Q3) | 1.66 (0.40, 4.21) | 1.58 (0.65, 2.89) | -0.44 (-2.17, 0.63) |
| Average % time >180 mg/dL (SD) | 38.4 (20.1) | 16.9 (10.3) | -21.5 (16.0) |
| Average % time ≥250 mg/dL (SD) | 13.1 (13.2) | 3.9 (3.9) | -9.1 (11.4) |
| Average % time ≥300 mg/dL (SD) | 4.3 (6.7) | 1.2 (1.6) | -3.1 (6.1) |

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CGM Results at Various Target Glucose Settings

| Characteristic | 110 mg/dL Target Glucose (n=47) | 120 mg/dL Target Glucose (n=61) | 130 mg/dL Target Glucose (n=47) | 140 mg/dL Target Glucose (n=20) | 150 mg/dL Target Glucose* (n=16) |
| --- | --- | --- | --- | --- | --- |
| Average % time 70-180 mg/dL (SD) | 69.3 (9.5) | 68.3 (11.3) | 67.3 (14.6) | 63.0 (11.9) | 65.0 (15.0) |
| Average sensor glucose, mg/dL (SD) | 152.8 (17.6) | 156.5 (20.6) | 161.3 (25.2) | 169.2 (18.1) | 169.3 (20.3) |
| Median % time <54 mg/dL (Q1, Q3) | 0.33 (0.16, 0.73) | 0.22 (0.14, 0.53) | 0.17 (0.05, 0.68) | 0.17 (0.03, 0.53) | 0.06 (0.00, 0.21) |
| Median % time <70 mg/dL (Q1, Q3) | 2.39 (1.48, 3.91) | 1.63 (1.11, 2.73) | 1.41 (0.60, 2.86) | 1.43 (0.37, 2.66) | 0.79 (0.13, 1.95) |
| Average % time >180 mg/dL (SD) | 27.6 (10.5) | 29.3 (12.1) | 30.4 (15.4) | 35.4 (12.2) | 33.9 (15.0) |
| Average % time ≥250 mg/dL (SD) | 7.7 (5.9) | 8.9 (6.2) | 10.6 (9.4) | 12.6 (6.2) | 11.4 (7.2) |
| Cumulative number of person-days | 2438.4 | 3083.5 | 1066.6 | 404.0 | 237.0 |

*Glycemic measures reported at the 150 mg/dL Target Glucose setting only included those with Activity mode turned OFF.

Change in Insulin Requirements During the Study

| Characteristic | Standard Therapy | OmniPod 5 | Change* |
| --- | --- | --- | --- |
| Average total daily insulin, U/kg (SD) | 0.69 (0.18) | 0.71 (0.15) | 0.02 (0.10) |
| Average total daily basal insulin, U/kg (SD) | 0.28 (0.12) | 0.32 (0.10) | 0.04 (0.11) |
| Average total daily bolus insulin, U/kg (SD) | 0.41 (0.15) | 0.39 (0.10) | -0.02 (0.10) |

*Change is calculated as insulin requirements during OmniPod 5 phase minus insulin requirements during standard therapy phase.

## Body Mass Index Results

The table below provides information on the average body mass index (BMI), which is a measure of weight adjusted for height; and BMI z-score, which is a measure of weight adjusted for height, sex, and age, during the standard therapy phase and the 3-month OmniPod 5 System treatment phase (Phase 2).

| Characteristic | Standard Therapy | OmniPod 5 | Change |
| --- | --- | --- | --- |
| Average BMI, kg/m³ (SD) | 16.7 (1.5) | 16.7 (1.4) | 0.1 (1.0) |
| Average BMI z-score (SD) | 0.74 (0.95) | 0.76 (0.89) | 0.05 (0.63) |

## Change in HbA1c from the Study

The table below provides information on the average change in HbA1c% from the beginning of the study (baseline) to the end of the 3-month Omnipod 5 System treatment phase. Participants

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experienced a reduction in HbA1c after 3 months of Omnipod 5 System use regardless of baseline HbA1c &lt; 8% or ≥ 8% category.

| | Baseline HbA1c <8% (n=55) | | | Baseline HbA1c ≥8% (n=25) | | |
| --- | --- | --- | --- | --- | --- | --- |
| Characteristic | Baseline | OmniPod 5 | Change | Baseline | OmniPod 5 | Change |
| Average | 6.9 (0.6) | 6.6 (0.6) | -0.31 | 8.5 (0.5) | 7.5 (0.4) | -1.06 |
| HbA1c% (SD) | | | (0.39) | | | (0.60) |

## Subgroup Analysis of Average Results by Baseline Treatment

The table below provides information on the average glycemic results at baseline (or during standard therapy phase) and the 3-month Omnipod 5 System treatment phase analyzed by baseline treatment (standard therapy). Standard therapy consisted of multiple daily insulin injections (MDI) or insulin pump use.

| | MDI (n=12) | | Insulin Pump (n=68) | |
| --- | --- | --- | --- | --- |
| Characteristic | Standard Therapy | OmniPod 5 | Standard Therapy | OmniPod 5 |
| Average % Time in range 70-180 mg/dL | 48.4 | 61.8 | 58.7 | 69.2 |
| Median % time <70 mg/dL | 1.45 | 1.48 | 2.44 | 2.00 |
| Average HbA1c% | 8.4 | 7.5 | 7.3 | 6.8 |

## 2. Human Factors Testing:

Human factors validation testing was conducted with the Omnipod 5 App installed on a compatible mobile device with interoperable technology. The final device design was evaluated in the summative study performed with 16 representative participants (i.e., caregivers of children 2-5.9 years old) interacting with the device in a simulated use environment. All study participants received training that was consistent with the training that patients would receive with the commercial product. Usability evaluations assessed comprehension and usability of the device for critical device tasks. Results of the study demonstrated that the device could be used safely by intended users in the intended use environment when used in combination with a digitally connected device.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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