Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Not Applicable

Completed

Conditions: Type 1 Diabetes Mellitus

Interventions: Device: Omnipod Horizon™ Automated Glucose Control System

Registration Number: NCT04476472

Lead Sponsor: Insulet Corporation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Omnipod Horizon™ Automated Glucose Control System	All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin (A1C)	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	Measures device effectiveness
Time in Range 70-180 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)	Measures device effectiveness
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)	Number of severe hypoglycemia events reported in "events per person months" units.
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)	Number of DKA events reported in "events per person months" units.

Secondary Outcome Measures

Name	Time	Method
Percent of Time > 180 mg/dL	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	Glucose metric from study continuous glucose monitoring system (CGM)
Percent of Time ≥ 250 mg/dL	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	Glucose metric from study continuous glucose monitoring system (CGM)
Percent of Time < 70 mg/dL	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	Glucose metric from study continuous glucose monitoring system (CGM)
Total Daily Basal Insulin (Units/kg)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Percent of Time in Range 70-140 mg/dL	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	Glucose metric from study continuous glucose monitoring system (CGM)
Glycated Hemoglobin (A1C)	Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline	Measures device effectiveness
Percent of Time < 54 mg/dL	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	Glucose metric from study continuous glucose monitoring system (CGM)
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time	Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)	Measure of system usage in Automated and Manual modes. Percentage of time in Automated and Manual mode do not add up to 100% due to missing data from participants not using the Omnipod 5 system (e.g., not wearing a Pod).
Total Daily Insulin (TDI) (Units)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Total Daily Basal Insulin (Units)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Mean Glucose	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	Glucose metric from study continuous glucose monitoring system (CGM)
Standard Deviation	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	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Coefficient of Variation	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	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Total Daily Bolus Insulin (Units)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Percent of Time ≥ 300 mg/dL	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	Glucose metric from study continuous glucose monitoring system (CGM)
Glucose Management Indicator (GMI)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more.
Total Daily Insulin (TDI) (Units/kg)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Body Mass Index (BMI) (kg/m^2)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline	Measure of change in weight
Total Daily Bolus Insulin (Units/kg)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements

Trial Locations

Locations (10): Stanford University
🇺🇸
Palo Alto, California, United States
International Diabetes Center
🇺🇸
Saint Louis Park, Minnesota, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Atlanta Diabetes
🇺🇸
Atlanta, Georgia, United States
SUNY Syracuse
🇺🇸
Syracuse, New York, United States
University Hospitals Cleveland
🇺🇸
Cleveland, Ohio, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Colorado Denver
🇺🇸
Denver, Colorado, United States
Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States