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Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activity on Board
Usual Diabetes Care
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Activity on Board

Usual Diabetes Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 3, 2018
Last Updated
May 21, 2018
Sponsor
University of Virginia
Collaborators
DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03394352
Brief Title
Exercise Activity-Based Bolus Decisions in Type 1 Diabetes
Official Title
A Pilot Study of Activity-Based Bolus Decisions in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Insulin pump, Continuous Glucose Monitor (CGM), Exercise, Activity on Board, Decision Support System

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activity on Board
Arm Type
Experimental
Arm 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.
Arm Title
Usual Diabetes Care
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Activity on Board
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Usual Diabetes Care
Intervention 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.
Primary Outcome Measure Information:
Title
Continuous Glucose Monitor metrics
Description
Record CGM metrics with the primary outcome analysis of percentage time <70 mg/dL by CGM following exercise comparing the experimental to control admission
Time Frame
about 9-12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc D. Breton, Ph.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

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