Status:
RECRUITING
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Lead Sponsor:
University of California, Davis
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
Design: Randomized, controlled trial of two different telehealth modalities as supplements to usual diabetes care over a six-month period for pediatric patients with T1D and suboptimal glycemic contro...
Eligibility Criteria
Inclusion
- age 5-18 years
- diagnosis of type 1 diabetes with a duration of \>12 months
- 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
- intention to receive diabetes care at the UCD Pediatric Diabetes Clinic during the following year
- access to the internet via a device with video and audio capability
- 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
- Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04428658
Start Date
September 15 2022
End Date
July 1 2025
Last Update
March 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California-Davis
Sacramento, California, United States, 95817