NCT04428658Recruiting
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 5 Jun 2020
- Start date
- 15 Sept 2022
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- University of California, Davis
- Diseases
- Type 1 diabetes
- NCT number
- NCT04428658
What you commit to
- Study type: Interventional
- Planned participants: 82
- From 15 Sept 2022 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
Who the study is looking for
- 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.
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California - Davis Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.