Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

The purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in Type 1 Diabetes.

Key facts

Study ID

NCT03394352

Run by

University of Virginia

People needed

15

Starts

2018-01-17

Expected to finish

2018-05-11

Last updated by the study team

2018-05-23

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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