Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus, Hypoglycemia

In brief

This is a randomized crossover trial with 1:1 randomization to the admission sequence of using the Control AP system (rMPC - Naïve Model Predictive Control) vs. Experimental AP system (EnMPC - Ensemble Model Predictive Control) over approximately 4 months. Eligible participants will proceed to the Data Collection Phase for approximately 28 days, during which they will participate in regimented exercise activities. If the participant collected adequate data during the Data Collection Phase, they will be randomized and undergo the study admissions in the assigned sequence. Each admission is approximately 36 hours in length and will consist of one afternoon of exercise and one without.

Key facts

Study ID: NCT03859401
Run by: Marc Breton
People needed: 15
Starts: 2019-04-12
Expected to finish: 2020-01-13
Last updated by the study team: 2026-05-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 and ≤65 years
Clinical diagnosis of Type 1 Diabetes for at least one year
Currently using an insulin pump for at least 6 months
Uses insulin parameters such as carbohydrate ratio and correction factors consistently on their insulin pump in order to dose insulin for meals or corrections
Access to internet and willingness to upload data during the study
Willingness to be physically active for at least 30 minutes per day at least 4 times per week
Willingness to perform the required exercise regimen during Data Collection Period
Willingness to not perform regular exercise outside of the study-regimented exercise window
For females, not currently pregnant or breastfeeding. If a female is of child-bearing potential and sexually active, she must agree to use a form of contraception to prevent pregnancy while participating in the study.
An understanding and willingness to follow the protocol and sign 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
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider and documentation of a negative stress test within the year
History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician.
Use of non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) with the exception of participants who have been on a stable dose of Metformin for at least 3 months.
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
Inpatient psychiatric treatment in the past 6 months
Presence of a known adrenal disorder
Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
Uncontrolled thyroid disease
Use of an automated insulin delivery mechanism that is not FDA approved during the data collection phase
Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
Inability to be physically active for at least 30 minutes per day for at least 4 times per week
Current enrollment in another clinical trial, unless approved by the investigators of both studies or if clinical trial is a non-interventional registry trial.

Where it is running

University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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