NCT04428658 · University of California, Davis
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
What this study is about
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 treatment group$1 and a control treatment group$1 receiving usual care.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- -Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
Where
- Sacramento, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2025 · Source of record for eligibility and locations