International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

Key facts

Study ID

NCT02844517

Run by

University of Virginia

People needed

43

Starts

2016-11-01

Expected to finish

2017-10-01

Last updated by the study team

2018-05-07

Who can join

Age: 14 and older, up to 74. 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 with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
• Age 14.0 to <75.0 years
• HbA1c level <10.5% at screening
• 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 serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night
• Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
• 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)
• Total daily insulin dose (TDD) less than 100 U/day

You may not qualify if…

• More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
• More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment
• Medical need for chronic acetaminophen
• Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
• 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 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
• Mt. Sinai — New York, New York, United States
• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States
• University of Montpellier — Montpellier, France
• University of Padova — Padova, Italy
• Academic Medical Center — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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