Omnipod 5 algorithm

K251779 · Insulet Corporation · QJI · Dec 3, 2025 · Clinical Chemistry

Device Facts

• Record ID: K251779
• Device Name: Omnipod 5 algorithm
• Applicant: Insulet Corporation
• Product Code: QJI · Clinical Chemistry
• Decision Date: Dec 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Indications for Use

The Omnipod 5 algorithm 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. The Omnipod 5 algorithm is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 5 algorithm is intended for single patient use and requires a prescription.

Device Story

Software-only device enabling automated insulin delivery; part of Omnipod 5 System. Inputs: glucose values from compatible iCGM. Processing: algorithm calculates insulin micro-bolus outputs based on current/predicted glucose. Outputs: insulin delivery commands to connected ACE Pump. Used in ambulatory settings by patients. Healthcare providers use output to manage glycemic control; system operates in Automated Mode (closed-loop) or Manual Mode (open-loop). Benefits: automated insulin adjustment to maintain target glucose levels. Updates include 100 mg/dL target glucose option and modified alert behavior.

Clinical Evidence

No new clinical studies. Evidence provided via in silico virtual clinical trial (N=125 digital twins, ages 2-70) and statistical extrapolation of real-world evidence (RWE) from 32,332 users. Simulations compared 100 mg/dL target against 110 mg/dL RWE. Results showed increased time in range (65.9% vs 63.4%) and reduced time above range (32.3% vs 35.1%) with acceptable safety profiles across age cohorts. Statistical extrapolation confirmed consistent outcomes.

Technological Characteristics

Software-only medical device (iAGC). Operates as part of an interoperable automated glycemic controller system. Implements rule-based and predictive control logic for insulin delivery. Connectivity via wireless integration with iCGM and ACE pump. Complies with ANSI AAMI IEC 62304 (software lifecycle) and ANSI AAMI ISO 14971 (risk management).

Indications for Use

Indicated for management of type 1 diabetes mellitus in persons 2+ years and type 2 diabetes mellitus in persons 18+ years. Requires prescription; for single patient use.

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 (K241777)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K251779

B Applicant

Insulet Corporation

C Proprietary and Established Names

Omnipod 5 algorithm

D Regulatory Information

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

## E Purpose for Submission

Modification to a cleared device to

- Add 100 mg/dL as a target glucose value input to the algorithm.
- Modify the Automated Delivery Restricted (ADR) alert to allow users to remain in Automated Mode after acknowledging the Alert.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The Omnipod 5 algorithm 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. The Omnipod 5 algorithm is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 5 algorithm is intended for single patient use and requires a prescription.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

- The Omnipod 5 algorithm should NOT be used by anyone under the age of 2 years old. The Omnipod 5 algorithm 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 The Omnipod 5 algorithm in pregnant women, critically ill patients, and those on dialysis. The safety of The Omnipod 5 algorithm has not been evaluated in these populations. Consult with your healthcare provider if any of these conditions apply to you before using The Omnipod 5 algorithm.
- DO NOT use the Omnipod 5 System if you do not have adequate vision and/or hearing to recognize all functions of the Omnipod 5 System including alerts, alarms, and reminders according to instructions.
- ONLY use rapid-acting U-100 NovoLog® (insulin aspart), Humalog® (insulin lispro), and Admelog® (insulin lispro) insulin in the Omnipod 5 System as they have been tested and found to be safe for use with this system. NovoLog, Humalog, and Admelog are compatible with the Omnipod 5 System for use up to 72 hours (3 days). Follow your healthcare provider’s directions for how often to replace the Pod.
- AVOID administering insulin, such as by injection or inhalation, while wearing an active Pod as this could result in hypoglycemia. The Omnipod 5 System cannot track insulin that is administered outside of the system. Consult your healthcare provider about how long to wait after manually administering insulin before you start Automated Mode.
- AVOID changing your SmartBolus Calculator settings before consulting with your healthcare provider. Incorrect changes could result in over-delivery or under-delivery of insulin, which can lead to hypoglycemia or hyperglycemia. Settings that impact bolus calculations mainly include: Max Bolus, Minimum Glucose for Calculations, Correct Above, Correction Factor(s), Insulin to Carb (IC) ratio(s), Duration of Insulin Action, and Target Glucose.
- Do NOT use Omnipod 5 System with a Dexcom Sensor if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. Your Dexcom sensor glucose values could be falsely elevated and could result in over-delivery of insulin which can lead to severe hypoglycemia.
- DO NOT use the Omnipod 5 System with the FreeStyle Libre 2 Plus Sensor if you are taking more than 1000 mg of ascorbic acid (Vitamin C) per day, a substance found in supplements like multivitamins or cold remedies such as Airborne® and Emergen-C®. Taking more than 1000 mg of Vitamin C per day may falsely raise your Sensor readings and result in over-delivery of insulin that could result in severe hypoglycemia.
- ALWAYS respond to Hazard Alarms as soon as they occur. Pod Hazard Alarms indicate that insulin delivery has stopped. Failure to respond to a Hazard Alarm could result in under-delivery of insulin which can lead to hyperglycemia.
- DO NOT use the Omnipod 5 System at low atmospheric pressure (below 700hPa). You could encounter such low atmospheric pressures at high elevations, such as when mountain climbing or living at elevations above 10,000 feet (3,000 meters). Change in atmospheric pressure can also occur during take-off with air travel. Unintended insulin delivery can occur if there is expansion of tiny air bubbles that may exist inside the Pod. This can result in hypoglycemia. It is important to check your glucose frequently when flying to avoid prolonged hypoglycemia.

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- DO NOT use the Omnipod 5 System in oxygen rich environments (greater than 25% oxygen), which include home or surgical areas that use supplementary oxygen and hyperbaric chambers. Hyperbaric, or high pressure, chambers are sometimes used to promote healing of diabetic ulcers, or to treat carbon monoxide poisoning, certain bone and tissue infections, and decompression sickness. Exposure to oxygen rich environments could result in combustion of the Pod or Omnipod 5 Controller, which can cause severe burns to the body.
- DO NOT use the Omnipod 5 System in high atmospheric pressure environments (above 1060 hPA), which can be found in a hyperbaric chamber. Hyperbaric, or high pressure, chambers, are sometimes used to promote healing of diabetic ulcers, or to treat carbon monoxide poisoning, certain bone and tissue infections, and decompression sickness. Exposure to high atmospheric pressure environments can damage your Pod and Omnipod 5 Controller which could result in under-delivery of insulin which can lead to hyperglycemia.
- Device components including the Pod, Dexcom G6 Sensor and Transmitter, Dexcom G7 Sensor, and FreeStyle Libre 2 Plus Sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components.

## III Device/System Characteristics:

The device is the Omnipod 5 (OP5) algorithm (formerly called the SmartAdjust technology), which is a software-only medical device and is part of the OP5 Automated Insulin Delivery System composed of the following devices:

- Omnipod 5 ACE Pump (Pod) initially cleared under K203768 and most recently cleared under K231826.
- Omnipod 5 Algorithm (iAGC) initially cleared under K203774 and most recently cleared under K241777.
- SmartBolus Calculator initially cleared under K203772 and most recently cleared under K231824).
- Third-party iCGM (cleared for use with Dexcom G6 and G7 and Abbott Freestyle Libre 2)

The OP5 algorithm (iAGC) calculates insulin micro-boluses every 5 minutes based upon the predicted glucose over a 60-minute prediction horizon. The OP5 algorithm can also provide autocorrection boluses in response to hyperglycemia.

The OP5 system is a hybrid closed loop system and can operate in either open loop (Manual Mode) or closed loop (Automated Mode). When Automated Mode is enabled, the OP5 algorithm controls insulin delivery based on recent iCGM values. Automated Mode has three states of operation: fully Automated, Automated: Limited (i.e., Limited Mode), and Activity.

- In fully Automated mode, the Algorithm calculates and adjusts insulin delivery based on several factors including the user's set glucose target, total daily insulin (TDI), and sensor glucose values.
- Limited Mode is enabled when the iAGC is not receiving data from a connected iCGM for 20 minutes or more. While in Limited Mode, the user will receive basal insulin at or below either the pre-programmed basal rate or the rate based on past insulin usage, whichever is less. Once the iAGC and iCGM are back into range and a valid EGV is

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received from the iCGM, the system will resume delivery of insulin in fully Automated mode.

- Activity is intended for use during periods when insulin sensitivity is expected to be higher, such as during exercise. The feature can be set for various time durations during Automated mode. With Activity, the algorithm reduces insulin delivery by setting a temporary glucose target to 150 mg/dL. Activity has a maximum selectable duration of 24 hours.

## IV Substantial Equivalence Information:

A Predicate Device Name(s):

SmartAdjust™ Technology

B Predicate 510(k) Number(s):

K241777

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K251779 | K241777 |
| --- | --- | --- |
| Device Trade Name | Omnipod 5 algorithm | SmartAdjust Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Omnipod 5 algorithm 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. The Omnipod 5 algorithm is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 5 algorithm is intended for single patient use and requires a prescription. | Same |
| General Device Characteristic Differences | | |

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| Target Glucose | 100-150 mg/dl, user-customizable | 110-150 mg/dl, user-customizable |
| --- | --- | --- |
| Automated Delivery Restriction (ADR) Alert is triggered | 2 hr after reaching the lower or upper bound constraint. User will be allowed to remain in the automated mode. | 1 hr after reaching the lower or upper bound constraint. User will exit to manual mode. |

V Standards/Guidance Documents Referenced:

- ANSI AAMI IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes
- ANSI AAMI ISO 14971:2019 – Medical devices – Applications of risk management to medical devices

VI Performance Characteristics (if/when applicable):

A Non-Clinical Performance:

There have been no changes to the Omnipod 5 algorithm’s design, architecture, logical flows, or principles of operation from the predicate device cleared under K241777. For the changes proposed in this submission, software testing for the candidate device included unit testing, integration testing, design verification component-level testing, design system level testing, and design validation testing. All acceptance criteria have passed in these tests.

B Clinical Studies:

No new clinical studies were conducted to support substantial equivalence of the subject devices.

C Other Supportive Device Performance Characteristics Data:

Glycemic outcomes in people with diabetes using the Omnipod 5 Automated Insulin Delivery System with target glucose setting of 100 mg/dL was validated by a virtual clinical trial study using in silico simulations. This virtual clinical trial study used a multi-arm design to compare glycemic outcomes of digital twins at the new target glucose setting of 100 mg/dL with those of real-world users of the Omnipod 5 algorithm (also referred to as SmartAdjust technology) at target glucose settings of 110 mg/dL. The trial included 125 digital twins that were constructed using clinical data, including data from the Omnipod 5 pivotal study and other sources.

Information supporting credibility of the models used in the simulations was reviewed and found to be sufficient given the context of use. The following types of information, in addition to other information, were provided to support model credibility:

- Code verification was performed to verify the correct implementation of the simulator component models (e.g., iAGC, iCGM, and patient model).
- Details on the methods used for parameter optimization and training of digital twins was provided.

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- Emergent model behavior: digital twins were tested to confirm physiologically correct glucose response to specific situations, including withholding of insulin, high insulin doses during fasting, and meals consumed without insulin.
- Population-based comparison of digital twin attributes (i.e., insulin therapy and physiological parameters) to those of the real world Omnipod 5 users.
- In vivo validation: as shown in the table below, the virtual cohort of digital twins were validated by matching the real-world data (RWD) of Omnipod 5 users with one target glucose setting (i.e., 130 mg/dL) after the digital twins were calibrated using RWD of Omnipod 5 users with other target glucose settings (i.e., 110 and 120 mg/dL). Statistical analysis using a two-sample t-test for the validation metric of difference in glycemic outcomes between the 130 mg/dL and 110 mg/dL setpoints (denoted as Δ(SP130, SP110)) indicates no statistically significant difference between simulated and real-world outcomes.

| Metric Δ(SP130, SP110) | Simulated Outcomes | RWE Outcomes | p-value |
| --- | --- | --- | --- |
| % time in 70-180 mg/dL | -5.9±4.1 | -5.6±8.8 | 0.7 |
| % time above 180 mg/dL | 6.5±3.9 | 6.0±9.1 | 0.6 |
| % time below 70 mg/dL | -0.6±0.6 | -0.4±1.1 | 0.1 |
| Total daily insulin delivery (U) | -4.0±1.5 | -4.0±10.5 | 1.0 |

The virtual clinical trial study and its results are summarized below:

- Virtual Trial Design
- N=125 digital twins representing subjects with T1D aged 2 to 70 years
- Age groups: 85 subjects ages >20 years, 18 subjects ages 13-19 years, 22 subjects ages 2-13 years
- 72 simulation scenarios combining the following parameters:
- Insulin needs: nominal therapy, more intense therapy than the need, less intense therapy than the need
- Initial glucose level: 70, 110, 200, 250 mg/dL
- Meal size: no meal, average meal, and large meal
- Rescue carbohydrate behavior: triggered after 15 or 30 minutes of hypoglycemia
- 12-hour simulation duration with 100 mg/dL target glucose value for each digital twin and each simulation scenario.

The results of the simulations were reviewed and found to be adequate to support a finding of substantial equivalence, as well as the applicable special controls required for interoperable automated glycemic controllers listed in 21 CFR 862.1356 (b)(1)(i). Virtual clinical trial results for primary outcomes (100 mg/dL in silico results vs 110 mg/dL real-world data) and age-specific safety profile are presented in tables 1 and 2 below, respectively.

The simulated clinical study showed numerical differences in times spent in different CGM glucose ranges for simulated subjects using the 100 mg/dL setpoint when compared to RWE

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results for subjects using a $110\mathrm{mg / dL}$ setpoint. Specifically, the study showed reduced time above range, increased time in range, and increased time below range. These findings are consistent with the general trend observed in prior in vivo clinical studies of this device, where lowering the target glucose level reduces time above range, increases time in range, and increases time below range.

Table 1: Glycemic outcomes between Target Glucose ${100}\mathrm{{mg}}/\mathrm{{dL}}$ (simulated) and ${110}\mathrm{{mg}}/\mathrm{{dL}}$ (from RWE)

| Endpoints | Target Glucose 100 mg/dL (Simulated), mean ± SD | Target Glucose 110 mg/dL (RWE), mean ± SD |
| --- | --- | --- |
| % time in 70-180 mg/dL | 65.9±12.2 | 63.4±13.7 |
| % time > 180 mg/dL | 32.3±12.9 | 35.1±14.2 |
| % time < 70 mg/dL | 1.8±1.6 | 1.5±1.5 |
| % time < 54 mg/dL | 0.5±0.8 | 0.3±0.5 |
| Total daily insulin use (U) | 49.4±18.3 | 46.9±21.5 |

Table 2: In silico simulation results for different age cohorts

| | All | Adults | Adolescents | Pediatrics |
| --- | --- | --- | --- | --- |
| Target Glucose 100 mg/dL (simulated) | | | | |
| % time in 70-180 mg/dL | 65.9±12.2 | 67.9±11.7 | 60.6±11.0 | 62.8±13.6 |
| % time > 180 mg/dL | 32.3±12.9 | 30.4±12.5 | 37.6±12.0 | 34.8±14.3 |
| % time < 70 mg/dL | 1.8±1.6 | 1.7±1.5 | 1.8±2.0 | 2.4±1.8 |
| % time < 54 mg/dL | 0.5±0.8 | 0.5±0.7 | 0.5±1.0 | 0.4±0.9 |
| Total Daily Insulin (U) | 49.4±18.3 | 49.3±18.2 | 59.1±12.5 | 41.0±19.6 |
| Target Glucose 110 mg/dL (RWE) | | | | |
| % time in 70-180 mg/dL | 63.4±13.7 | 64.7±13.6 | 59.1±14.3 | 61.8±12.7 |
| % time > 180 mg/dL | 35.1±14.2 | 33.9±14.1 | 39.5±14.8 | 36.2±13.3 |
| % time < 70 mg/dL | 1.5±1.5 | 1.3±1.6 | 1.4±1.3 | 1.9±1.6 |
| % time < 54 mg/dL | 0.3±0.5 | 0.3±0.5 | 0.3±0.4 | 0.4±0.5 |
| Total Daily Insulin (U) | 46.9±21.5 | 47.1±21.2 | 56.2±19.3 | 38.9±21.0 |

The sponsor also estimated the $100\mathrm{mg / dL}$ setpoint outcomes using a complementary, statistical approach. RWE was collected from 32,332 device users of the 110, 120 and $130\mathrm{mg / dL}$ setpoints

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(568 +/- 259 days). A statistical regression model (linear mixed effects) was fit to the characterize glycemic outcomes for these set points. This model was then used to extrapolate predictions of glycemic outcomes under a hypothetical $100\mathrm{mg/dL}$ setpoint. The results of this extrapolation are provided in Table 3 below.

Table 3: RWE extrapolation results for different age cohorts

| | All | Adults | Adolescents | Pediatrics |
| --- | --- | --- | --- | --- |
| % time in 70-180 mg/dl | 66.3±12.4 | 68.2±12.2 | 61.2±12.8 | 63.3±11.3 |
| % time > 180 mg/dl | 32.0±12.8 | 30.3±12.7 | 37.2±13.2 | 34.5±11.7 |
| % time < 70 mg/dl | 1.7±1.2 | 1.6±1.2 | 1.6±1.1 | 2.2±1.3 |
| Total Daily Insulin (U) | 49.2±19.4 | 49.0±19.3 | 58.2±17.8 | 42.7±18.4 |

# VII Proposed Labeling:

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

# VIII Conclusion:

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

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