RECRUITINGINTERVENTIONAL
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
-Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
BEHAVIORAL
Supplemental video visits
Receiving home-based video visits with a pediatric endocrinologist monthly as a supplement to regular diabetes clinic visits.
BEHAVIORAL
Standard of Care
Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
BEHAVIORAL
Supplemental remote monitoring
Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.
Locations (1)
University of California-Davis
Sacramento, California, United States