NCT02897557CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Insulet Corporation
- Enrollment
- 59
- Locations
- 4
- Primary Endpoint
- Percentage of time in hypoglycemic range (defined as <70 mg/dL)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Single Cohort in CRC
Experimental
This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting.
Intervention: Insulet Artificial Pancreas (AP) System (Device)
Outcomes
Primary Outcomes
Percentage of time in hypoglycemic range (defined as <70 mg/dL)
Time Frame: 36 hours
Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL)
Time Frame: 36 hours
Secondary Outcomes
- Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL)(36 hours)
- Percentage of time < 50 mg/dL(36 hours)
- Percentage of time >/= 300 mg/dL(36 hours)
- Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL)(36 hours)
- Mean glucose(36 hours)
- Percentage of time < 60 mg/dL(36 hours)
- Percentage of time > 180 mg/dL(36 hours)
- Standard deviation and coefficient of variation of CGM values(36 hours)
Investigators
Study Sites (4)
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