The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

Completed · Not applicable

Conditions studied: Type1 Diabetes Mellitus

In brief

The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

Key facts

Study ID

NCT02985866

Run by

University of Virginia

People needed

127

Starts

2017-10-27

Expected to finish

2018-09-04

Last updated by the study team

2022-12-05

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
• Use of an insulin pump for at least 6 months
• Age ≥14 years old
• HbA1c level <10.5% at screening
• For females, not currently known to be pregnant
• Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study
• Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use
• Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service
• Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
• For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency

You may not qualify if…

• Medical need for chronic acetaminophen
• Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
• 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 including any contraindication to the use of any of the study devices per FDA labeling
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Use of a closed-loop system within the last month prior to enrollment
• Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Where it is running

• William Sansum Diabetes Center — 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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