The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus
In brief
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.
Key facts
- Study ID
- NCT03591354
- Run by
- University of Virginia
- People needed
- 164
- Starts
- 2019-01-17
- Expected to finish
- 2020-03-09
- Last updated by the study team
- 2022-08-31
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Successful completion of the original 6-month RCT within the prior 14 days
- For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
- Willingness to not use a personal CGM for the duration of the study
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
You may not qualify if…
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Dexcom, Inc., or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Where it is running
- Sansum Diabetes Research Institute — Santa Barbara, California, United States
- Stanford University — Stanford, California, United States
- Barbara Davis Center, University of Colorado — Aurora, Colorado, United States
- Harvard University (Joslin Diabetes Center) — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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