Prepivotal Omnipod Horizon™ Automated Glucose Control System

Study Overview
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Brief Summary
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Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.

Detailed Description
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The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting. The hybrid closed-loop phase will begin on Study Day 1. During the hybrid closed-loop phase, subjects will be divided into two groups. The first group of subjects will commence the hybrid closed-loop phase in the hotel/rental house setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining 12 days. After all subjects from the first group have completed the 2-day hotel/rental house phase, the second group of subjects may commence the hybrid closed-loop phase in an outpatient setting for 14-days. During the hybrid closed-loop phase, all subjects will participate in specific target blood glucose (BG) challenges. After each subject in the prepivotal study has successfully completed 14-days of hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.

Official Title
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Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Omnipod Horizon™ Automated Glucose Control System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at time of consent/assent 6-70 years Subjects aged < 18 years must be living with parent/legal guardian Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment. Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog, or Apidra during the study Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria Willing to wear the system continuously throughout the study A1C <10% at screening visit Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight Able to read and speak English fluently Subject must be in an AT&T covered area Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged < 18 years per State requirements. Exclusion Criteria: A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months History of DKA (as defined in Section 11.3.4) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis Diagnosed with sickle cell disease Diagnosed with hemophilia or any other bleeding disorders Plans to receive blood transfusion over the course of the study Currently diagnosed with anorexia nervosa or bulimia Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis History of adrenal insufficiency Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the course of the study Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. For subjects >50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms) Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant) Participation in another clinical study using an investigational drug or device within the preceding 30-days or intends to participate during the study period Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm, multi-center, prospective clinical study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm | Device: Omnipod Horizon™ Automated Glucose Control System<br>* The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Severe Hypoglycemia | Measure of serious device-related adverse events | hybrid closed-loop (14 days) | 
| Proportion of Subjects With Diabetic Ketoacidosis (DKA) | Measure of serious device-related adverse events | hybrid closed-loop (14 days) | 
| Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Percentage of time in range 70-180 mg/dL | hybrid closed-loop (9 days) compared to standard therapy (14 days) | 
| Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Percentage of time in range 70-180 mg/dL | hybrid closed-loop (5 days) compared to standard therapy (14 days) | 
| Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Percentage of time in range 70-180 mg/dL | hybrid closed-loop (14 days) compared to standard therapy (14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glucose | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Time in Range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Time in Range 70-140 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Percentage of Time >180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Percentage of Time ≥250 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Percentage of Time ≥300 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Percentage of Time <70 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Percentage of Time <54 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Standard Deviation of Glucose (mg/dL) | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | 
| Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Measurement of glucose management using overall glucose averages | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | 
| Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Measure of system usage | hybrid closed-loop (14 days) | 
| Total Daily Insulin (TDI) (Units, Units/kg) | Measure of insulin requirements | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | 
| Total Daily Basal Insulin (Units, Units/kg) | Measure of insulin requirements | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | 
| Total Daily Bolus Insulin (Units, Units/kg) | Measure of insulin requirements | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omnipod, T1D