Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

NCT04476472 | Completed Results DMC FDA Device

• 1 other identifier: Horizon™ Preschool Cohort
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

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)

  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 Outcomes (19)

• Glycated Hemoglobin (A1C)

  Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline

• Percent of Time in Range 70-140 mg/dL

  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

  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

  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

  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

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: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

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
• Clinical evidence of 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)
• Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
• 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
• 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

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (10)

Stanford University

Palo Alto, California, 94305, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

International Diabetes Center

Saint Louis Park, Minnesota, 55416, 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

Related Publications (2)

• DeSalvo DJ, Bode BW, Forlenza GP, Laffel LM, Buckingham BA, Criego AB, Schoelwer M, MacLeish SA, Sherr JL, Hansen DW, Ly TT. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod(R) 5 Automated Insulin Delivery System. Diabetes Technol Ther. 2024 Jun;26(6):383-393. doi: 10.1089/dia.2023.0506. Epub 2024 Feb 21.

  PMID: 38277156 DERIVED

• 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.

  PMID: 35678724 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 School of Medicine

  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: single-arm, multi-center, prospective clinical study

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: September 8, 2020
• Primary Completion: January 17, 2022
• Study Completion: October 12, 2022
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)