Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Insulet Corporation80 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Omnipod Horizon™ Automated Glucose Control SystemDEVICE

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (10)

Stanford University

Palo Alto, California, United States

University of Colorado Denver

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Incidence Rate of Severe Hypoglycemia (Events Per Person Months)

Number of severe hypoglycemia events reported in "events per person months" units.

Time frame: 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.

Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)

Glycated Hemoglobin (A1C)

Measures device effectiveness

Time frame: 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

Time frame: 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

Glycated Hemoglobin (A1C)

Measures device effectiveness

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Atlanta, Georgia, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

International Diabetes Center

Saint Louis Park, Minnesota, 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline