Pivotal Omnipod Horizon™ Automated Glucose Control System

Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Omnipod Horizon™ Automated Glucose Control System

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, 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.

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

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • International Diabetes Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
    • Syracuse, New York, United States, 13244
      • SUNY Syracuse
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)
Incidence rate of diabetic ketoacidosis (DKA) (events per person months)	Measure of serious device-related adverse events	Phase 2 hybrid closed-loop (94 days)
Glycated hemoglobin (A1C)	Measures device effectiveness	6 weeks continuous Phase 2 participation compared to baseline
Time in range 70-180 mg/dL	Measures device effectiveness	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percent of time >180 mg/dL	Glucose metric from study continuous glucose monitoring system (CGM)	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
percent of time <70 mg/dL	Glucose metric from study continuous glucose monitoring system (CGM)	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Glycated hemoglobin (A1C)	Measures device effectiveness	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)
Mean glucose	Glucose metric from study continuous glucose monitoring system (CGM)	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
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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 days) compared to baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of hypoglycemia (<70 mg/dL confirmed by BG)	Measure of device safety	HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge)
Average number of hypoglycemic events (<70 mg/dL confirmed by BG)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Area under the curve (AUC) less than 70 mg/dL (based on CGM value)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Minimum continuous glucose monitor value (nadir glucose)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Area under the curve (AUC) greater than 180 mg/dL (based on CGM value)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Mean absolute decrease in glucose (based on CGM value, from start of exercise to nadir glucose)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Carbohydrates consumed during exercise (grams)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Mean glucose	Glucose metric from study continuous glucose monitoring system (CGM)	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
percent of time in range 70-180 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
percent of time > 180 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
percent of time ≥ 250 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
percent of time ≥ 300 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
percent of time < 70 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
percent of time < 54 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Standard deviations	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Coefficient of variation	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise

Collaborators and Investigators

• Sponsor: Insulet Corporation
• Investigators: Study Chair: Sue Brown, MD, University of Virginia; Study Chair: Bruce Buckingham, MD, Stanford University

Publications and helpful links

General Publications

• Polonsky WH, Hood KK, Levy CJ, MacLeish SA, Hirsch IB, Brown SA, Bode BW, Carlson AL, Shah VN, Weinstock RS, Bhargava A, Jones TC, Aleppo G, Mehta SN, Laffel LM, Forlenza GP, Sherr JL, Huyett LM, Vienneau TE, Ly TT; Omnipod 5 Research Group. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod(R) 5 System. Diabetes Res Clin Pract. 2022 Aug;190:109998. doi: 10.1016/j.diabres.2022.109998. Epub 2022 Jul 16.
• Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT; Omnipod 5 Research Group. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1630-1640. doi: 10.2337/dc21-0172. Epub 2021 Jun 7.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Actual): September 22, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: T1D; Omnipod
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Horizon™ Pivotal Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes