Pivotal Omnipod Horizon™ Automated Glucose Control System

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT04196140
• 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 (Phase 1 or ST) 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 (Phase 2), 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 (Phase 3).

During the hybrid closed-loop phase, there will be supervised exercise challenges. A subset of subjects will participate in 5-days of supervised Meal and Exercise challenges. A subset of subjects will participate in 3-days of supervised HypoProtect Exercise challenges where comparisons were made between exercising in Automated Mode vs initiating HypoProtect 60 minutes prior to exercise vs initiating HypoProtect 30 minutes prior to exercise.

The hybrid closed-loop phase will begin on Study Day 1.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2019-12-30
• Primary Completion: 2020-07-10
• Study Completion: 2022-04-20
• Results First Submitted: 2023-10-31
• Results First Submitted QC: 2024-04-23
• Results First Posted: 2024-05-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Age at time of consent/assent 6-70 years
2. Subjects aged < 18 years must be living with parent/legal guardian
3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
4. Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
5. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
6. Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
7. Must be willing to travel to and participate in meal and exercise challenges during 5-days of the hybrid closed-loop phase
8. Willing to wear the system continuously throughout the study
9. A1C <10% at screening visit
10. Must be willing to use the Dexcom App on the Omnipod Horizon™ Personal Diabetes Manager (PDM) as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
11. 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
12. Able to read and speak English fluently
13. 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

1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
2. History of severe hypoglycemia in the past 6 months
3. History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
4. Diagnosed with sickle cell disease
5. Diagnosed with hemophilia or any other bleeding disorders
6. Plans to receive blood transfusion over the course of the study
7. Currently diagnosed with anorexia nervosa or bulimia
8. Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
9. History of adrenal insufficiency
10. 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
11. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
12. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
13. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
14. 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.
15. 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)
16. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
17. 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)
18. Participation in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System within the preceding 30-days or intends to participate during the study period
19. 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

Primary Outcome Measures

Name	Time	Method
Time in Range 70-180 mg/dL	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)	Measures device effectiveness
Glycated Hemoglobin (A1C)	6 weeks continuous Phase 2 participation compared to baseline	Measures device effectiveness
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)	Phase 2 hybrid closed-loop (94 days)	Measure of serious device-related adverse events
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)	Phase 2 hybrid closed-loop (94 days)	Measure of serious device-related adverse events

Secondary Outcome Measures

Name	Time	Method
Total Daily Insulin (TDI) (Units/kg)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Glycated Hemoglobin (A1C)	at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 days)	Measures device effectiveness
Percent of Time in Range 70-180 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 in Range 70-140 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 days)	Measure of system usage
Percent of Time >180 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 Bolus Insulin (Units/kg)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 days) compared to baseline	Measure of change in weight
Percent of Time <70 mg/dL	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)	Glucose metric from study continuous glucose monitoring system (CGM)
Total Daily Bolus Insulin (Units)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 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 ≥ 300 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 < 54 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 Coefficient of Variation (of Glucose)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Percent Glucose Management Indicator (% GMI)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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. Percent GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of \<7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more).
Total Daily Basal Insulin (Units/kg)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements
Percent of Time ≥ 250 mg/dL	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 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 (of Glucose)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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)
Total Daily Insulin (TDI) (Units)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 days) compared to the Phase 1 standard therapy (14 days)	Measure of insulin requirements

Trial Locations

Locations (16)

Stanford University; 🇺🇸 Palo Alto, California, United States

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Atlanta Diabetes; 🇺🇸 Atlanta, Georgia, United States

East Coast Institute for Research; 🇺🇸 Macon, Georgia, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Iowa Diabetes; 🇺🇸 West Des Moines, Iowa, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

International Diabetes Center; 🇺🇸 Saint Louis Park, Minnesota, United States

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