Status:
COMPLETED
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
Lead Sponsor:
Marc Breton
Conditions:
Type 1 Diabetes Mellitus
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 - Ensembl...
Detailed Description
Exercise remains a challenge to AP systems; more specifically, by the time exercise is detected it is often too late to avoid hypoglycemia without the ingestion of rapid carbohydrates or the use of re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03859401
Start Date
April 12 2019
End Date
January 13 2020
Last Update
January 18 2020
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908