Diabetes Closed Loop Protocol (DCLP1)

Clinical Study Details

Title

Clinical Acceptance of the Artificial Pancreas: The International Diabetes Closed Loop (iDCL) Trial

Description

We are looking for those 14 and older with type 1 diabetes to take part in testing the inControl closed loop system, developed by TypeZero Technologies, Inc. This system is comprised of a Roche pump, a Dexcom CGM, and an Android phone that houses the inControl closed loop platform. Eligible participants will be randomized to either use the closed-loop system at home or continue with their usual insulin therapy with a study CGM for about 17 weeks. There will be multiple in person clinic visits in addition to phone contacts during the study time period.

Inclusion Criteria

  1. Diagnosed with type 1 diabetes for at least 1 year
  2. Use of an insulin pump for at least 6 months
  3. Age 14 or older
  4. HbA1c level <10.5% at screening
  5. For females, not currently know to be pregnant
  6. For subjects <18 years old, living with one or more parent/legal guardian committed to participating in study training in case of an emergency

Exclusion Criteria

  1. Medical need for chronic acetaminophen
  2. Use of any glucose-lowering agent in the 3 months prior to enrollment
  3. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  4. Use of a closed-loop system within the last month prior to enrollment

More Info

If you're interested in learning more about this study, please reach out to the research coordinator listed on the right. You may also download the consent form, assent form, and any other documents linked on the right.


Study Contact

Liana Hsu

650-725-3939

ljhsu@stanford.edu