Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort

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: Completed
• 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, 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • International Diabetes Center
  • New York
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age at time of consent 2.0-5.9 years
2. Living with parent/legal guardian
3. Diagnosed with type 1 diabetes. 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 and/or parent/guardian/caregiver 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. Willing to wear the system continuously throughout the study
8. 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%
9. A1C <10% at screening visit
10. 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
11. Subject and/or parent/guardian is able to read and speak English fluently
12. Has a parent/legal guardian willing and able to sign the ICF.

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. Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
8. History of adrenal insufficiency
9. 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
10. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
11. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
12. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
13. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
14. 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
15. 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)	Number of severe hypoglycemia events reported in "events per person months" units.	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)	Number of DKA events reported in "events per person months" units.	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Glycated Hemoglobin (A1C)	Measures device effectiveness	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
Time in Range 70-180 mg/dL	Measures device effectiveness	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated Hemoglobin (A1C)	Measures device effectiveness	Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
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 (450 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 (450 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 (450 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 (450 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 (450 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 (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Mean Glucose	Glucose metric from study continuous glucose monitoring system (CGM)	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
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 (450 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 (450 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 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).	Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
Glucose Management Indicator (GMI)	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.	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 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 (450 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 (450 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 (450 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 (450 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 (450 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 (450 days) compared to the Phase 1 standard therapy (14 days)
Body Mass Index (BMI) (kg/m^2)	Measure of change in weight	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT; Omnipod 5 in Preschoolers Study Group:; Sherr JL, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode BW, Busby A, Forlenza GP, Wadwa RP, Slover R, Cobry E, Messer L, Laffel LM, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown SA, Krauthause K, Emory E, Oliveri M, Buckingham BA, Ekhlaspour L, Kingman R, Criego AB, Schwartz BL, Gandrud LM, Grieme A, Hyatt J, DeSalvo DJ, McKay S, DeLaO K, Villegas C, MacLeish SA, Wood JR, Kaminski BA, Casey T, Campbell W, Behm K, Adams R, Hansen DW, Stone SL, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly TT, Dumais B, Vienneau T, Huyett LM, Lee JB, O'Connor J, Benjamin E. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care. 2022 Aug 1;45(8):1907-1910. doi: 10.2337/dc21-2359.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

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™ Preschool Cohort

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