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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Marc Breton
Study ID
NCT03859401
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • EnMPC (Ensemble Model Predictive Control) AP Controller — DEVICE
    This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
  • rMPC (Naïve Model Predictive Control) AP Controller — DEVICE
    This AP controller does not have the ability to anticipate exercise activity.

Study Details

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 Dates

Start date
Apr 12, 2019
Status verified
Apr 2026
Primary completion
Jan 13, 2020
Completion
Jan 13, 2020

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Control - Experimental Admissions
    Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Control-Experimental Arm will undergo the Control Admission first, utilizing an artificial pancreas (AP) controller that does not anticipate exercise (rMPC - naïve model predictive control), followed by the Experimental Admission, which will utilize an AP controller that has the ability to anticipate exercise (EnMPC - ensemble model predictive control). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
  • Experimental: Experimental - Control Admissions
    Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Experimental-Control Arm will undergo the Experimental Admission first, utilizing an artificial pancreas (AP) controller that has the ability to anticipate exercise (EnMPC), followed by the Control Admission, which will utilize an AP controller that does not have the ability to anticipate exercise (rMPC). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.

Primary Outcome Measure

Number of Hypoglycemic Occurrences in Relation to Exercise Activity [ Time Frame: 2 Hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Charlottesville, VA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Virginia· Charlottesville, VA

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