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Clinical Trials/NCT03228004
NCT03228004
Completed
Phase 1

Type 1 Diabetes Data Acquisition and Transfer Adherence Study

University of Florida1 site in 1 country53 target enrollmentJuly 26, 2017

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
University of Florida
Enrollment
53
Locations
1
Primary Endpoint
Improved glycemic control
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.

Registry
clinicaltrials.gov
Start Date
July 26, 2017
End Date
April 8, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis with T1D at least 6 months before consent is obtained
  • Aged ≥ 2 years and ≤17 years at time of enrollment
  • Must have access to a smartphone, tablet or computer at home with wireless connectivity
  • Last HbA1c of ≥7.6% and ≤11%
  • Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen
  • Ability to read and speak English
  • Patient at UF Health Pediatric Diabetes Clinic

Exclusion Criteria

  • Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up
  • Inability to read and speak English
  • Not using insulin therapy
  • Lack of access to mobile device or computer with wireless internet connectivity
  • Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload

Outcomes

Primary Outcomes

Improved glycemic control

Time Frame: 16 weeks

HbA1c

Frequency of data upload

Time Frame: 16 weeks

The number of times glucose data is uploaded between clinic visits

Study Sites (1)

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