Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).

Key facts

Study ID

NCT04545567

Run by

University of Virginia

People needed

21

Starts

2020-12-16

Expected to finish

2021-01-21

Last updated by the study team

2022-04-20

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥12.0 and ≤25 years old at time of consent
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Currently using insulin for at least six months
• Currently using insulin pump for at least three months
• Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
• Access to internet and willingness to upload data during the study as needed
• For females, not currently known to be pregnant or breastfeeding
• 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 females of childbearing 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.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• Willingness to use the UVa artificial pancreas system throughout study sessions.
• Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
• Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission
• Willingness to reschedule Study Dinner Sessions if placed on oral steroids
• An understanding and willingness to follow the protocol and signed informed consent

You may not qualify if…

• History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• Pregnancy or intent to become pregnant during the trial
• Currently being treated for a seizure disorder
• Planned surgery during study duration
• Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
• Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team

Where it is running

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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