Type 1 Diabetes Data Acquisition and Transfer Adherence Study

Type 1 Diabetes Mellitus Clinical Trial

— T1D-DATA  

Official title:

Type 1 Diabetes Data Acquisition and Transfer Adherence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228004
• Other study ID #: IRB201700818
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2017
• Est. completion date: April 8, 2019

Study information

• Verified date: April 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 8, 2019
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Glooko MeterSync
The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved glycemic control	HbA1c	16 weeks
Primary	Frequency of data upload	The number of times glucose data is uploaded between clinic visits	16 weeks