Insulet Artificial Pancreas Early Feasibility Study
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulet Artificial Pancreas (AP) System
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the study:
- Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
- Diagnosed with type 1 diabetes for at least 1 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 for at least 6 months prior to start of study
- Willing to use the study CGM device for one week prior to study start and for the duration of the study
- Willing to use the OmniPod® Insulin Management System during the study
- Willing to perform all SMBG 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 refrain from use of acetaminophen, pseudoephedrine, 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) and/or has a parent or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
- 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 or more "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 on the abdomen
- Known history of myocardial infarction (MI) or stroke within the past 6 months
- Known history of seizure disorder
- Known history of adrenal insufficiency
- Current renal or hepatic disease
- Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
- Currently undergoing cancer treatment
- Currently undergoing systemic treatment with steroids or immunosuppressive medication
- History of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants
- Current illness that would interfere with participation in the study
- Untreated or inadequately treated mental illness
- Current alcohol abuse per investigator's judgment
- Electrically-powered implants that may be susceptible to RF interference
- Currently participating in another clinical study testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days
- 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
- William Sansum Diabetes Center
- Diablo Clinical Research
- University of Colorado Denver
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Cohort in CRC
Arm Description
This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.
Outcomes
Primary Outcome Measures
Percentage of time in hypoglycemic range (defined as <70 mg/dL)
Percentage of time in severe 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 in the broad euglycemic range (defined as 70-180) mg/dL)
Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)
Standard deviation and coefficient of variation of CGM values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02897557
Brief Title
Insulet Artificial Pancreas Early Feasibility Study
Official Title
A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 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
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Cohort in CRC
Arm Type
Experimental
Arm Description
This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.
Intervention Type
Device
Intervention Name(s)
Insulet Artificial Pancreas (AP) System
Primary Outcome Measure Information:
Title
Percentage of time in hypoglycemic range (defined as <70 mg/dL)
Time Frame
36 hours
Title
Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
Mean glucose
Time Frame
36 hours
Title
Percentage of time < 50 mg/dL
Time Frame
36 hours
Title
Percentage of time < 60 mg/dL
Time Frame
36 hours
Title
Percentage of time > 180 mg/dL
Time Frame
36 hours
Title
Percentage of time >/= 300 mg/dL
Time Frame
36 hours
Title
Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)
Time Frame
36 hours
Title
Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)
Time Frame
36 hours
Title
Standard deviation and coefficient of variation of CGM values
Time Frame
36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the study:
Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
Diagnosed with type 1 diabetes for at least 1 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 for at least 6 months prior to start of study
Willing to use the study CGM device for one week prior to study start and for the duration of the study
Willing to use the OmniPod® Insulin Management System during the study
Willing to perform all SMBG 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 refrain from use of acetaminophen, pseudoephedrine, 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) and/or has a parent or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
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 or more "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 on the abdomen
Known history of myocardial infarction (MI) or stroke within the past 6 months
Known history of seizure disorder
Known history of adrenal insufficiency
Current renal or hepatic disease
Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
Currently undergoing cancer treatment
Currently undergoing systemic treatment with steroids or immunosuppressive medication
History of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants
Current illness that would interfere with participation in the study
Untreated or inadequately treated mental illness
Current alcohol abuse per investigator's judgment
Electrically-powered implants that may be susceptible to RF interference
Currently participating in another clinical study testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days
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
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
William Sansum Diabetes Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
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 Early Feasibility Study
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