Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

May 21, 2018 updated by: Marc Breton, University of Virginia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Center for Diabetes Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activity on Board
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.
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.
Placebo Comparator: Usual Diabetes Care
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous Glucose Monitor metrics
Time Frame: about 9-12 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

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

Investigators

  • Principal Investigator: Marc D. Breton, Ph.D., University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20319
  • DP3DK106826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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