Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394352
• Other study ID #: 20319
• Secondary ID: DP3DK106826
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: May 11, 2018

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Activity on Board
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.
• Usual Diabetes Care
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.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Glucose Monitor metrics	Record CGM metrics with the primary outcome analysis of percentage time <70 mg/dL by CGM following exercise comparing the experimental to control admission	about 9-12 hours