Improving diabetes control in kids using telehealth
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
This study is testing if using video calls and remote monitoring can help kids with type 1 diabetes manage their blood sugar better than just regular check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04428658 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests whether supplemental synchronous video visits and asynchronous remote monitoring can improve glycemic control in pediatric patients with type 1 diabetes over six months. The study compares health outcomes and patient-centered outcomes among two intervention groups and a control group receiving standard care. Participants will be recruited from the University of California, Davis Pediatric Diabetes Clinic, either during in-person visits or via phone for those receiving telehealth. Eligible patients are aged 5-18 years with suboptimal glycemic control and must have access to the internet and compatible devices.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 years with type 1 diabetes and suboptimal glycemic control.
Not a fit: Patients living outside California will not benefit due to licensing restrictions on telehealth services.
Why it matters
Potential benefit: If successful, this approach could lead to better glycemic control and improved health outcomes for children with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with telehealth interventions for diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Sacramento, California
- University of California-Davis — Sacramento, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.