Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

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 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.

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 94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 12 months. During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges. The hybrid closed-loop phase will begin on Study Day 1.

Official Title
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Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort

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 2.0-5.9 years Living with parent/legal guardian Diagnosed with type 1 diabetes. 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 and/or parent/guardian/caregiver 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 Willing to wear the system continuously throughout the study Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50% A1C <10% at screening visit Subject and/or parent/guardian 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 Subject and/or parent/guardian is able to read and speak English fluently Has a parent/legal guardian willing and able to sign the ICF. 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 in the past 6 months History of DKA 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 Clinical evidence of 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) Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this 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: 2 Years
Maximum Age: 5 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: 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 |
| --- | --- | --- |
| Incidence rate of severe hypoglycemia (events per person months) | Measure of serious device-related adverse events | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) | 
| Incidence rate of diabetic ketoacidosis (DKA) (events per person months) | Measure of serious device-related adverse events | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) | 
| Glycated hemoglobin (A1C) | Measures device effectiveness | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline | 
| Time in range 70-180 mg/dL | Measures device effectiveness | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (A1C) | Measures device effectiveness | Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline | 
| Percent of time in range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percent of time in range 70-140 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percent of time > 180 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percent of time ≥ 250 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percent of time ≥ 300 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percent of time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percent of time < 54 mg/dL | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Mean glucose | Glucose metric from study continuous glucose monitoring system (CGM) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Standard deviation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 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) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | 
| Percentage of time in hybrid closed-loop as proportion of overall device usage time | Measure of system usage | Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days) | 
| Glucose management indicator (GMI) based on overall mean glucose | Measurement of glucose management using overall glucose averages | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Total daily insulin (TDI) (units) | Measure of insulin requirements | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Total daily insulin (TDI) (units/kg) | Measure of insulin requirements | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Total daily basal insulin (units) | Measure of insulin requirements | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Total daily basal insulin (units/kg) | Measure of insulin requirements | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Total daily bolus insulin (units) | Measure of insulin requirements | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Total daily bolus insulin (units/kg) | Measure of insulin requirements | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | 
| Body Mass Index (BMI) (kg/m2) | Measure of change in weight | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline | 

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