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Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes

RecruitingNAAges 5 Years - 18 YearsAllUniversity of California, Davis
NCT04428658 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will test the hypothesis that supplemental synchronous video visits and supplemental asynchronous remote monitoring can each significantly improve glycemic control for pediatric patients with uncontrolled type 1 diabetes over a 6 month period, and will compare health outcomes and patient-centered outcomes between these two intervention arms and a control arm receiving usual care.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. age 5-18 years 2. diagnosis of type 1 diabetes with a duration of \>12 months 3. suboptimal glycemic control at time of enrollment, defined as a hemoglobin A1c (HbA1c) level \> 8% (64 mmol/mol) or a 14-day glucose management index (GMI) of \>8% from continuous glucose monitoring (CGM) data or 14-day average blood glucose of \>200 mg/dl in the preceding month 4. intention to receive diabetes care at the UCD Pediatric Diabetes Clinic during the following year 5. access to the internet via a device with video and audio capability 6. ability to connect the patient's home blood glucose meter or CGM device - as well as insulin pump, if applicable - to an internet-capable device via Bluetooth or physical cable. Exclusion Criteria: -Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
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What it tests

  • Supplemental video visits
  • Standard of Care
  • Supplemental remote monitoring
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Where

1 site
University of California-Davis
Sacramento, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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