Type 1 Diabetes Data Acquisition and Transfer Adherence Study (T1D-DATA)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glooko MeterSync
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.
Outcomes
Primary Outcome Measures
Improved glycemic control
HbA1c
Frequency of data upload
The number of times glucose data is uploaded between clinic visits
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03228004
Brief Title
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
Acronym
T1D-DATA
Official Title
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.
Intervention Type
Behavioral
Intervention Name(s)
Glooko MeterSync
Intervention Description
The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.
Primary Outcome Measure Information:
Title
Improved glycemic control
Description
HbA1c
Time Frame
16 weeks
Title
Frequency of data upload
Description
The number of times glucose data is uploaded between clinic visits
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Albanese-O'Neill, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
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