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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California-Davis
RECRUITING
Sacramento
Time Frame
Start Date: 2022-09-15
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 82
Treatments
Experimental: Supplemental video visits
Participants in this intervention arm will receive home-based video visits with a pediatric endocrinologist every month for the duration of 6 months in addition to usual care.
Active_comparator: Standard of Care
The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic.
Experimental: Supplemental remote monitoring
Participants in this intervention arm will receive remote glucose monitoring with monthly asynchronous outreach from a pediatric endocrinologist for a duration of six months in addition to usual care.
Related Therapeutic Areas
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov