Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2) (IDE2)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulet AP (artificial pancreas) System
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 1 Diabetes Mellitus focused on measuring T1D, Omnipod
Eligibility Criteria
Inclusion Criteria:
- Age at time of consent 18.0 to 65.0 years
- Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
- Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening
- Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start
- Willing to use the study CGM device for the duration of the study
- Willing to use the Omnipod® Insulin Management System during the study
- Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol
- Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
- Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
- Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
- Willing and able to sign the Informed Consent Form (ICF)
Exclusion Criteria:
- A1C >10% at the screening visit
- One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
- Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
- One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
- Used non-insulin anti-diabetic medication within last 30 days
- 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)
- Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
- Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
- Currently undergoing systemic treatment with steroids or immunosuppressive medication
- Current illness that would interfere with participation in the study
- Currently participating in another clinical study using an investigational drug or device
- Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.
Sites / Locations
- Stanford University
- Diablo Clinical Research
- University of Colorado Denver
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Meal Performance and/or Exercise
Arm Description
This study is a two-part, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting using the Insulet AP (artificial pancreas) system. Subjects may participate in hybrid closed-loop session Option A - Meal Performance and/or Option B - Exercise, but are not required to participate in both. If participating in both, Option A and Option B must be conducted in separate sessions.
Outcomes
Primary Outcome Measures
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
Secondary Outcome Measures
Mean glucose
Percentage of time < 50 mg/dL
Percentage of time < 60 mg/dL
Percentage of time > 180 mg/dL
Percentage of time ≥ 300 mg/dL
Percentage of time between 70-180 mg/dL
Percentage of time between 70-140 mg/dL
Standard deviation
Coefficient of variation
Meal challenge-12 hour PPG dinner
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner.
Meal challenge-4 hour PPG breakfast
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast.
Meal challenge-4 hour PPG lunch
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch.
Exercise challenge-immediate and delayed glucose response
The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise.
Effect of changing setpoints
Effect of changing setpoints to overall performance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03064906
Brief Title
Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
Acronym
IDE2
Official Title
Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 18, 2017 (Actual)
Primary Completion Date
April 7, 2017 (Actual)
Study Completion Date
April 7, 2017 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
Detailed Description
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
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
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour (Option A - Meal Performance and/or Option B - Exercise), hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting. Subjects may participate in hybrid closed-loop session Option A and/or Option B.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meal Performance and/or Exercise
Arm Type
Other
Arm Description
This study is a two-part, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting using the Insulet AP (artificial pancreas) system.
Subjects may participate in hybrid closed-loop session Option A - Meal Performance and/or Option B - Exercise, but are not required to participate in both. If participating in both, Option A and Option B must be conducted in separate sessions.
Intervention Type
Device
Intervention Name(s)
Insulet AP (artificial pancreas) System
Intervention Description
Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.
Primary Outcome Measure Information:
Title
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Time Frame
54 hours
Title
Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL)
Time Frame
54 hours
Secondary Outcome Measure Information:
Title
Mean glucose
Time Frame
54 hours
Title
Percentage of time < 50 mg/dL
Time Frame
54 hours
Title
Percentage of time < 60 mg/dL
Time Frame
54 hours
Title
Percentage of time > 180 mg/dL
Time Frame
54 hours
Title
Percentage of time ≥ 300 mg/dL
Time Frame
54 hours
Title
Percentage of time between 70-180 mg/dL
Time Frame
54 hours
Title
Percentage of time between 70-140 mg/dL
Time Frame
54 hours
Title
Standard deviation
Time Frame
54 hours
Title
Coefficient of variation
Time Frame
54 hours
Title
Meal challenge-12 hour PPG dinner
Description
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner.
Time Frame
54 hours
Title
Meal challenge-4 hour PPG breakfast
Description
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast.
Time Frame
54 hours
Title
Meal challenge-4 hour PPG lunch
Description
The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch.
Time Frame
54 hour
Title
Exercise challenge-immediate and delayed glucose response
Description
The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise.
Time Frame
54 hour
Title
Effect of changing setpoints
Description
Effect of changing setpoints to overall performance.
Time Frame
54 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at time of consent 18.0 to 65.0 years
Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening
Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start
Willing to use the study CGM device for the duration of the study
Willing to use the Omnipod® Insulin Management System during the study
Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol
Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
Willing and able to sign the Informed Consent Form (ICF)
Exclusion Criteria:
A1C >10% at the screening visit
One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
Used non-insulin anti-diabetic medication within last 30 days
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)
Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
Currently undergoing systemic treatment with steroids or immunosuppressive medication
Current illness that would interfere with participation in the study
Currently participating in another clinical study using an investigational drug or device
Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Buckingham, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
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