International Diabetes Closed Loop Trial: Could it Support FDA Approval?
Twitter Summary: NIH funds #IDCL study testing #closed-loop artificial pancreas system for six months at a time
Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page.
Trial Name: International Diabetes Closed Loop Trial (IDCL)
Diabetes Type: Type 1 Diabetes
What it's testing: This trial will assess the safety and efficacy of TypeZero’s inControl artificial pancreas system vs. a standard insulin pump + CGM (open loop). The inControl system is the commercial version of the UVA DiAs automated insulin delivery system, which Adam and Kelly took for a 24/7 test drive last year – it consists of a smartphone running the inControl artificial pancreas algorithm, a Dexcom CGM, and an insulin pump (it’s not known yet which insulin pump the TypeZero system will use). Participants will be randomized between the two groups: 160 participants will be in the inControlAP group and 80 participants in the sensor-augmented pump therapy group.
What the trial is measuring: Reduction in average blood sugar level and reduction of risk of hypoglycemic events.
Why is this new/important: This long-term study was designed with input from the FDA, and data from the first six months of this artificial pancreas trial could be used to submit the system for approval. The DiAs system was originally developed in an academic research setting, which was not sufficient for a commercial product. Startup TypeZero has licensed the technology, converted it into a consumer-ready product, and will help take the system through approval and to market (either alone or in tandem with partners). The company is still deciding who will submit the FDA application, and whether the control algorithm will be embedded into an insulin pump or remain on a smartphone.
Trial Length: Each person will stay in the IDCL trial for six months, and the entire study is planned to last 2.5 years.
Trial Location: The trial sites are: University of Virginia; Harvard University; Mount Sinai School of Medicine; the Mayo Clinic; Stanford University; the University of Colorado; the University of Padua, Italy; Regional University Hospital Center of Montpellier, France; the Academic Medical Center, Amsterdam; William Sansum Diabetes Center, Santa Barbara; with coordination by the JAEB Center for Health Research in Florida.
Do you qualify?
The trial is for adults with type 1 diabetes. Its webpage is not yet posted on clinicaltrials.gov, but interested individuals should contact artificialpancreas@virginia.edu for more information on inclusion and exclusion criteria. Additionally, people can write to this address to express interest in the study and give permission to the study's project coordinators to contact them when the IDCL protocol begins.
Thank you to all patients for continuing work on research front - we know not everybody can participate in trials, but this is a big one and we salute all of you who can try to be involved!
-CA/AB
