Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

A Pilot Study of Activity-Based Bolus Decisions in Type 1 Diabetes

Sponsors

Lead Sponsor: University of Virginia

Collaborator: DexCom, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source University of Virginia
Brief Summary

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.

Detailed Description

Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. The aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.

Overall Status Completed
Start Date January 17, 2018
Completion Date May 11, 2018
Primary Completion Date May 11, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Continuous Glucose Monitor metrics about 9-12 hours
Enrollment 15
Condition
Intervention

Intervention Type: Other

Intervention Name: Activity on Board

Description: During the collection phase, the study team will collect information on glucose values, activity measures and insulin settings. This information will be used to determine the meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the data collection phase and study admission.

Arm Group Label: Activity on Board

Intervention Type: Other

Intervention Name: Usual Diabetes Care

Description: Subjects will perform their usual diabetes care including basal rate, meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the study admission.

Arm Group Label: Usual Diabetes Care

Eligibility

Criteria:

Inclusion Criteria:

1. Type 1 Diabetes for at least one year

2. Using an insulin pump for at least 6 months

3. Age 18-65

4. Uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections

5. Access to internet and willing to upload data during the study

6. Willingness to maintain consistent activity regimen for 28 day collection period

7. 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.

8. Demonstration of proper mental status and cognition for the study.

9. An understanding of and willingness to follow the protocol and sign the informed consent.

Exclusion Criteria:

1. Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.

2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.

3. Pregnancy and intent to become pregnant during trial.

4. Use of acetaminophen is not allowed when CGM is in use

5. Use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide [GLP]-1 agonists, metformin)

6. 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)

7. Inability to be physically active for more than 30 minutes per day.

8. Current enrollment in another intervention clinical trial.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Marc D. Breton, Ph.D. Principal Investigator University of Virginia
Location
Facility: University of Virginia Center for Diabetes Technology
Location Countries

United States

Verification Date

May 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Virginia

Investigator Full Name: Marc Breton

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Activity on Board

Type: Experimental

Description: 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.

Label: Usual Diabetes Care

Type: Placebo Comparator

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov