Type 1 Diabetes Data Acquisition and Transfer Adherence Study

NCT03228004 | Completed Phase 1

• 1 other identifier: IRB201700818
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Improved glycemic control

  HbA1c

  16 weeks

• Frequency of data upload

  The number of times glucose data is uploaded between clinic visits

  16 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Glooko MeterSync BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anastasia Albanese-O'Neill, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: July 26, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 8, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (1)