Prepivotal Omnipod Horizon™ Automated Glucose Control System
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnipod Horizon™ Automated Glucose Control System
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring T1D, Omnipod
Eligibility Criteria
Inclusion Criteria:
- Age at time of consent/assent 6-70 years
- Subjects aged < 18 years must be living with parent/legal guardian
- Diagnosed with type 1 diabetes for at least 6 months. 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 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
- Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase
- Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria
- Willing to wear the system continuously throughout the study
- A1C <10% at screening visit
- 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
- 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
- Able to read and speak English fluently
- Subject must be in an AT&T covered area
- 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:
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months
- History of DKA (as defined in Section 11.3.4) 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
- Currently diagnosed with anorexia nervosa or bulimia
- 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)
- 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.
- 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)
- Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
- 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)
- Participation in another clinical study using an investigational drug or device within the preceding 30-days or intends to participate during the 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.
Sites / Locations
- Stanford University
- University of Colorado Denver
- Atlanta Diabetes
- International Diabetes Center
- Mount Sinai
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Outcomes
Primary Outcome Measures
Proportion of subjects with severe hypoglycemia
Measure of serious device-related adverse events
Proportion of subjects with diabetic ketoacidosis (DKA)
Measure of serious device-related adverse events
Target blood glucose (BG) challenge days (approximately hybrid closed-loop days 1-9)
Percentage of time in range 70-180 mg/dL
Non-challenge days (approximately hybrid closed-loop days 10-14)
Percentage of time in range 70-180 mg/dL
Overall (hybrid closed-loop days 1-14)
Percentage of time in range 70-180 mg/dL
Secondary Outcome Measures
Mean glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Time in range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time in range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
% of time >180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
% of time ≥250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
% of time ≥300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
% of time <70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
% of time <54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Standard deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Coefficient of variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Glucose management Indicator (GMI) based on overall mean glucose
Measurement of glucose management using overall glucose averages
Percentage of time in hybrid closed-loop as proportion of overall device usage time
Measure of system usage
Total daily insulin (TDI) (units, units/kg)
Measure of insulin requirements
Total daily basal insulin (units, units/kg)
Measure of insulin requirements
Total daily bolus insulin (units, units/kg)
Measure of insulin requirements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04176731
Brief Title
Prepivotal Omnipod Horizon™ Automated Glucose Control System
Official Title
Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insulet Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
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 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting.
The hybrid closed-loop phase will begin on Study Day 1.
During the hybrid closed-loop phase, subjects will be divided into two groups. The first group of subjects will commence the hybrid closed-loop phase in the hotel/rental house setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining 12 days. After all subjects from the first group have completed the 2-day hotel/rental house phase, the second group of subjects may commence the hybrid closed-loop phase in an outpatient setting for 14-days.
During the hybrid closed-loop phase, all subjects will participate in specific target blood glucose (BG) challenges.
After each subject in the prepivotal study has successfully completed 14-days of hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
T1D, Omnipod
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-arm, multi-center, prospective clinical study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Intervention Type
Device
Intervention Name(s)
Omnipod Horizon™ Automated Glucose Control System
Intervention Description
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Primary Outcome Measure Information:
Title
Proportion of subjects with severe hypoglycemia
Description
Measure of serious device-related adverse events
Time Frame
hybrid closed-loop (14 days)
Title
Proportion of subjects with diabetic ketoacidosis (DKA)
Description
Measure of serious device-related adverse events
Time Frame
hybrid closed-loop (14 days)
Title
Target blood glucose (BG) challenge days (approximately hybrid closed-loop days 1-9)
Description
Percentage of time in range 70-180 mg/dL
Time Frame
hybrid closed-loop (9 days) compared to standard therapy (14 days)
Title
Non-challenge days (approximately hybrid closed-loop days 10-14)
Description
Percentage of time in range 70-180 mg/dL
Time Frame
hybrid closed-loop (5 days) compared to standard therapy (14 days)
Title
Overall (hybrid closed-loop days 1-14)
Description
Percentage of time in range 70-180 mg/dL
Time Frame
hybrid closed-loop (14 days) compared to standard therapy (14 days)
Secondary Outcome Measure Information:
Title
Mean glucose
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
Time in range 70-180 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
Time in range 70-140 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
% of time >180 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
% of time ≥250 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
% of time ≥300 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
% of time <70 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
% of time <54 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
Standard deviation
Description
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
Coefficient of variation
Description
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
Title
Glucose management Indicator (GMI) based on overall mean glucose
Description
Measurement of glucose management using overall glucose averages
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Title
Percentage of time in hybrid closed-loop as proportion of overall device usage time
Description
Measure of system usage
Time Frame
hybrid closed-loop (14 days)
Title
Total daily insulin (TDI) (units, units/kg)
Description
Measure of insulin requirements
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Title
Total daily basal insulin (units, units/kg)
Description
Measure of insulin requirements
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days)
Title
Total daily bolus insulin (units, units/kg)
Description
Measure of insulin requirements
Time Frame
hybrid closed-loop (14 days) compared to the standard therapy (14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at time of consent/assent 6-70 years
Subjects aged < 18 years must be living with parent/legal guardian
Diagnosed with type 1 diabetes for at least 6 months. 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 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
Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase
Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria
Willing to wear the system continuously throughout the study
A1C <10% at screening visit
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
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
Able to read and speak English fluently
Subject must be in an AT&T covered area
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:
A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months
History of DKA (as defined in Section 11.3.4) 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
Currently diagnosed with anorexia nervosa or bulimia
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)
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.
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)
Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
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)
Participation in another clinical study using an investigational drug or device within the preceding 30-days or intends to participate during the 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Buckingham, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Atlanta Diabetes
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
International Diabetes Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prepivotal Omnipod Horizon™ Automated Glucose Control System
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