Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476472
• Other study ID #: Horizon™ Preschool Cohort
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: October 12, 2022

Study information

• Verified date: January 2024
• Source: Insulet Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 12, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Atlanta Diabetes	Atlanta	Georgia
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	University of Colorado Denver	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	International Diabetes Center	Saint Louis Park	Minnesota
United States	SUNY Syracuse	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Insulet Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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	Glycated Hemoglobin (A1C)	Measures device effectiveness	Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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