Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
University of California, Davis
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 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.
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 control. Recruitment: Patients will be recruited either: 1) during regularly scheduled in-person visits to the University of California, Davis (UCD) Pediatric Diabetes Clinic, or 2) via phone for patients receiving telehealth rather than in-person care from a UCD Pediatric Diabetes Clinic provider during the enrollment period. Inclusion criteria will be 1) age 5-18 years, 2) diagnosis of type 1 diabete…
Eligibility
- Age range
- 5–18 years
- Sex
- All
- Healthy volunteers
- No
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 bl…
Interventions
- BehavioralSupplemental video visits
Receiving home-based video visits with a pediatric endocrinologist monthly as a supplement to regular diabetes clinic visits.
- BehavioralStandard of Care
Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
- BehavioralSupplemental remote monitoring
Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.
Location
- University of California-DavisSacramento, California