Clinical Trial Details

NCT ID: NCT03216460
Date Last Changed: July 24, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Insulet automated glucose control system for the treatment of Type1 Diabetes Mellitus

Research Study Title

Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3

Purpose

Subjects will undergo a 7±1 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 CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

To Learn more

Recruitment Details

Gender
All
Age
6 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Insulet Corporation
Duration
3 Months
Facility Type
N/A
Compensation

Eligibility

All ages 6 Years to 65 Years

Inclusion Criteria:

  1. Age at time of consent ≥ 6 years and < 65 years

  2. Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.

  3. A1C < 10% at screening

  4. Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 6 months prior to study start

  5. Willing to use the study CGM device for the duration of the study

  6. Willing to use the Omnipod® Insulin Management System during the study

  7. Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol

  8. Using carbohydrate counting for determination of meal boluses

  9. Willing to participate in exercise for at least 30 minutes per day

  10. Willing to refrain from use of acetaminophen and supplemental vitamin C ( > 2000 mg/daily) for the entire duration of participation in the study

  11. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged ≥ 8 years.

Exclusion Criteria:

  1. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months

  2. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months

  3. Planning to start a non-insulin anti-diabetic medication during the study. If on non- insulin medication, dose must be stable in the previous 30 days.

  4. Using a basal insulin with a usual duration of insulin action > 36 hours

  5. 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)

  6. 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

  7. Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke.

  8. Known history of seizure disorder

  9. Known history of adrenal insufficiency

  10. Current renal or hepatic disease

  11. Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)

Site Locations (2)

Country State City Zip Facility and Contact
United States California Palo Alto 94305 Stanford University
Bruce Buckingham, MD
bbendo@stanford.edu
United States Colorado Denver 80045 University of Colorado Denver
Gregory Forlenza, MD
gregory.forlenza@ucdenver.edu

Contact

Trang Ly, MBBS
(978) 600-7229
E-mail:

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