Pivotal Omnipod Horizon™ Automated Glucose Control System

NCT04196140 | Completed Results DMC FDA Device

• 1 other identifier: Horizon™ Pivotal Study
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 16

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

T1D; Omnipod

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• Percent of Time >180 mg/dL

  Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

• Percent of Time <70 mg/dL

  Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

• 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)

• 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

• 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

Other Outcomes (16)

• Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG)

  HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge)

• Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG)

  HypoProtect compared to Automated Mode (3-day exercise challenge)

• Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value)

  HypoProtect compared to Automated Mode (3-day exercise challenge)

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: Omnipod Horizon™ Automated Glucose Control System

Interventions

Omnipod Horizon™ Automated Glucose Control System DEVICE

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

Treatment

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of consent/assent 6-70 years
• Subjects aged \< 18 years must be living with parent/legal guardian
• Diagnosed with type 1 diabetes for at least 6 months. 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 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
• Must be willing to travel to and participate in meal and exercise challenges during 5-days of the hybrid closed-loop phase
• Willing to wear the system continuously throughout the study
• A1C \<10% at screening visit
• 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
• 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
• Able to read and speak English fluently
• 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.

You may not qualify if:

• 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
• Currently diagnosed with anorexia nervosa or bulimia
• 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)
• 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.
• 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)

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (16)

Stanford University

Palo Alto, California, 94305, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

East Coast Institute for Research

Macon, Georgia, 31210, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Iowa Diabetes

West Des Moines, Iowa, 50265, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

SUNY Syracuse

Syracuse, New York, 13244, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (5)

• 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.

  PMID: 40303234 DERIVED

• 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.

  PMID: 37850941 DERIVED

• 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.

  PMID: 37311429 DERIVED

• 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.

  PMID: 35853530 DERIVED

• 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.

  PMID: 34099518 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Trang Ly
• Organization: Insulet Corporation

tly@insulet.com

9786007628

Study Officials

• Bruce Buckingham, MD

  Stanford University

  STUDY CHAIR

• Sue Brown, MD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, multi-center, prospective clinical study.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 12, 2019
• Study Start: December 30, 2019
• Primary Completion: July 10, 2020
• Study Completion: April 20, 2022
• Last Updated: April 3, 2025
• Results First Posted: May 14, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)