NCT03394352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

January 3, 2018

Last Update Submit

May 21, 2018

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusInsulin pumpContinuous Glucose Monitor (CGM)ExerciseActivity on BoardDecision Support System

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Activity on Board

EXPERIMENTAL

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

Usual Diabetes Care

PLACEBO COMPARATOR

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

Interventions

Activity on BoardOTHER

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.

Activity on Board
Usual Diabetes CareOTHER

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.

Usual Diabetes Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Marc D. Breton, Ph.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

January 17, 2018

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

US(1)