Clinical trial NCT04476472: Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: T1D
Omnipod
Lead sponsor: Insulet Corporation
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, multi-center, prospective clinical study
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
measure: Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
measure: Glycated Hemoglobin (A1C)
timeFrame: 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
measure: Time in Range 70-180 mg/dL
timeFrame: 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:
measure: Glycated Hemoglobin (A1C)
timeFrame: Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
measure: Percent of Time in Range 70-140 mg/dL
timeFrame: 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
measure: Percent of Time > 180 mg/dL
timeFrame: 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
measure: Percent of Time ≥ 250 mg/dL
timeFrame: 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
measure: Percent of Time ≥ 300 mg/dL
timeFrame: 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
measure: Percent of Time < 70 mg/dL
timeFrame: 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
measure: Percent of Time < 54 mg/dL
timeFrame: 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
measure: Mean Glucose
timeFrame: 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
measure: Standard Deviation
timeFrame: 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
measure: Coefficient of Variation
timeFrame: 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
measure: Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
measure: Glucose Management Indicator (GMI)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Total Daily Insulin (TDI) (Units)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Total Daily Insulin (TDI) (Units/kg)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Total Daily Basal Insulin (Units)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Total Daily Basal Insulin (Units/kg)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Total Daily Bolus Insulin (Units)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Total Daily Bolus Insulin (Units/kg)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
measure: Body Mass Index (BMI) (kg/m^2)
timeFrame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Diabetes
state: Georgia
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Saint Louis Park
country: United States
facility: International Diabetes Center
state: Minnesota
city: Syracuse
country: United States
facility: SUNY Syracuse
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Stanford School of Medicine
name: Bruce Buckingham, MD
role: STUDY_CHAIR
affiliation: University of Virginia
name: Sue Brown, MD
role: STUDY_CHAIR
References:
citation: 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.