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Completed

NCT Number: NCT03228004

Type 1 Diabetes Data Acquisition and Transfer Adherence Study

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Improved glycemic control

    Time frame: 16 weeks

    HbA1c

  2. Frequency of data upload

    Time frame: 16 weeks

    The number of times glucose data is uploaded between clinic visits

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: T1D-DATA

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 24, 2017
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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