Pivotal Omnipod Horizon™ Automated Glucose Control System

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196140
• Other study ID #: Horizon™ Pivotal Study
• Status: Completed
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: April 20, 2022

Study information

• Verified date: April 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 (Phase 1 or ST) 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 (Phase 2), 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 (Phase 3).

During the hybrid closed-loop phase, there will be supervised exercise challenges. A subset of subjects will participate in 5-days of supervised Meal and Exercise challenges. A subset of subjects will participate in 3-days of supervised HypoProtect Exercise challenges where comparisons were made between exercising in Automated Mode vs initiating HypoProtect 60 minutes prior to exercise vs initiating HypoProtect 30 minutes prior to exercise.

The hybrid closed-loop phase will begin on Study Day 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 20, 2022
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age at time of consent/assent 6-70 years

2. Subjects aged < 18 years must be living with parent/legal guardian

3. Diagnosed with type 1 diabetes for at least 6 months. 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 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. Must be willing to travel to and participate in meal and exercise challenges during 5-days of the hybrid closed-loop phase

8. Willing to wear the system continuously throughout the study

9. A1C <10% at screening visit

10. Must be willing to use the Dexcom App on the Omnipod Horizon™ Personal Diabetes Manager (PDM) as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase

11. Subjects scoring = 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight

12. Able to read and speak English fluently

13. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged < 18 years per State requirements.

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. Currently diagnosed with anorexia nervosa or bulimia

8. Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis

9. History of adrenal insufficiency

10. 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

11. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement

12. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study

13. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)

14. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12-months.

15. For subjects >50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)

16. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism

17. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)

18. Participation in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System within the preceding 30-days or intends to participate during the study period

19. 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	Northwestern University	Evanston	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	East Coast Institute for Research	Macon	Georgia
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai	New York	New York
United States	Stanford University	Palo Alto	California
United States	International Diabetes Center	Saint Louis Park	Minnesota
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	University of Washington	Seattle	Washington
United States	SUNY Syracuse	Syracuse	New York
United States	Iowa Diabetes	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Insulet Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG)	Measure of device safety	HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge)
Other	Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG)	Number of hypoglycemic events less than 70mg/dL which was confirmed with a blood glucose reading.	HypoProtect compared to Automated Mode (3-day exercise challenge)
Other	Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Other	Minimum Continuous Glucose Monitor Value (Nadir Glucose)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Other	Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Other	Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Other	Carbohydrates Consumed During Exercise (Grams)	Measure of device effectiveness	HypoProtect compared to Automated Mode (3-day exercise challenge)
Other	Mean Glucose	Glucose metric from study continuous glucose monitoring system (CGM)	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Percent of Time in Range 70-180 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Percent of Time > 180 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Percent of Time = 250 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Percent of Time = 300 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Percent of Time < 70 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Percent of Time < 54 mg/dL	Measure of device effectiveness	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Standard Deviation (of Glucose)	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Other	Coefficient of Variation (of Glucose)	Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.	Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
Primary	Incidence Rate of Severe Hypoglycemia (Events Per Person Months)	Measure of serious device-related adverse events	Phase 2 hybrid closed-loop (94 days)
Primary	Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)	Measure of serious device-related adverse events	Phase 2 hybrid closed-loop (94 days)
Primary	Glycated Hemoglobin (A1C)	Measures device effectiveness	6 weeks continuous Phase 2 participation compared to baseline
Primary	Time in Range 70-180 mg/dL	Measures device effectiveness	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Secondary	Percent of Time >180 mg/dL	Glucose metric from study continuous glucose monitoring system (CGM)	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Secondary	Percent of Time <70 mg/dL	Glucose metric from study continuous glucose monitoring system (CGM)	Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Secondary	Glycated Hemoglobin (A1C)	Measures device effectiveness	at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 days)
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Secondary	Percent of Time in Range 70-180 mg/dL	Glucose metric from study continuous glucose monitoring system (CGM)	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Secondary	Standard Deviation (of Glucose)	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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Secondary	Percent Coefficient of Variation (of Glucose)	Glucose metric from study continuous glucose monitoring system (CGM)- measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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	Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days)
Secondary	Percent 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. Percent GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of <7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more).	Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 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 (270 days) compared to baseline