Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03064906
- Run by
- Insulet Corporation
- People needed
- 24
- Starts
- 2017-03-18
- Expected to finish
- 2017-04-07
- Last updated by the study team
- 2018-06-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Stanford University — Palo Alto, California, United States
- Diablo Clinical Research — Walnut Creek, California, United States
- University of Colorado Denver — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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