Exercise Activity-Based Bolus Decisions in Type 1 Diabetes
Type 1 Diabetes Mellitus
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Insulin pump, Continuous Glucose Monitor (CGM), Exercise, Activity on Board, Decision Support System
Eligibility Criteria
Inclusion Criteria:
- Type 1 Diabetes for at least one year
- Using an insulin pump for at least 6 months
- Age 18-65
- Uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections
- Access to internet and willing to upload data during the study
- Willingness to maintain consistent activity regimen for 28 day collection period
- Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all women of child bearing potential. Subjects who become pregnant will be discontinued from the study.
- Demonstration of proper mental status and cognition for the study.
- An understanding of and willingness to follow the protocol and sign the informed consent.
Exclusion Criteria:
- Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
- Pregnancy and intent to become pregnant during trial.
- Use of acetaminophen is not allowed when CGM is in use
- Use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide [GLP]-1 agonists, metformin)
- Currently uses a clearly defined method for insulin bolusing to compensate for significant activity (e.g. marathon runner who uses temporary basal rates routinely and has separate basal profiles to account for exercise)
- Inability to be physically active for more than 30 minutes per day.
- Current enrollment in another intervention clinical trial.
Sites / Locations
- University of Virginia Center for Diabetes Technology
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Activity on Board
Usual Diabetes Care
Blinded CGM data will be collected prior to the Experimental Admission to determine the insulin bolus that will be determined by the activity on board calculator. Subjects will wear a continuous glucose monitor during the study admission.
Subjects will use their usual diabetes care, including basal rate, correction factor and carbohydrate-insulin ratio. Subjects will determine their own insulin usage during the Control Admission. Subjects will wear a continuous glucose monitor during the study admission.