Type 1 Diabetes Data Acquisition and Transfer Adherence Study

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT03228004
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Study Start: 2017-07-26
• Primary Completion: 2018-04-24
• Status Verified: 2019-04
• Study Completion: 2019-04-08
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improved glycemic control	16 weeks	HbA1c
Frequency of data upload	16 weeks	The number of times glucose data is uploaded between clinic visits

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States