Type 1 Diabetes Data Acquisition and Transfer Adherence Study (T1D-DATA)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Glooko MeterSync

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved glycemic control	HbA1c	16 weeks
Frequency of data upload	The number of times glucose data is uploaded between clinic visits	16 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Anastasia Albanese-O'Neill, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: IRB201700818

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No