Pivotal Omnipod Horizon™ Automated Glucose Control System

NCT ID: NCT04196140

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-30
• Study Completion Date: 2022-04-20

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Omnipod Horizon™ Automated Glucose Control System

Intervention Type: DEVICE

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Interventions

Omnipod Horizon™ Automated Glucose Control System

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insulet Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Buckingham, MD

Role: STUDY_CHAIR

Stanford University

Sue Brown, MD

Role: STUDY_CHAIR

University of Virginia

Locations

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

Mount Sinai

New York, New York, United States

SUNY Syracuse

Syracuse, New York, United States

University Hospitals Cleveland

Cleveland, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

Hood KK, Polonsky WH, MacLeish SA, Levy CJ, Forlenza GP, Criego AB, Buckingham BA, Bode BW, Hansen DW, Sherr JL, Brown SA, DeSalvo DJ, Mehta SN, Laffel LM, Bhargava A, Huyett LM, Vienneau TE, Ly TT. Psychosocial Outcomes with the Omnipod(R) 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers. Pediatr Diabetes. 2023 Jun 29;2023:8867625. doi: 10.1155/2023/8867625. eCollection 2023.

Reference Type: DERIVED

PMID: 40303234 (View on PubMed)

Criego AB, Carlson AL, Brown SA, Forlenza GP, Bode BW, Levy CJ, Hansen DW, Hirsch IB, 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. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jan;26(1):11-23. doi: 10.1089/dia.2023.0364. Epub 2023 Nov 30.

Reference Type: DERIVED

PMID: 37850941 (View on PubMed)

Hughes MS, Kingman RS, Hsu L, Lal RA, Buckingham BA, Zaharieva DP. Swimming With the Omnipod 5 Automated Insulin Delivery System: Connectivity in the Water. Diabetes Care. 2023 Aug 1;46(8):e148-e150. doi: 10.2337/dc23-0470. No abstract available.

Reference Type: DERIVED

PMID: 37311429 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35853530 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34099518 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Horizon™ Pivotal Study

Identifier Type: -

Identifier Source: org_study_id