NCT04428658 Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
| NCT ID | NCT04428658 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2022-09-15 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Frequently Asked Questions
Who can join the NCT04428658 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04428658 currently recruiting?
Yes, NCT04428658 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, Davis to inquire about joining.
Where is the NCT04428658 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT04428658 clinical trial?
NCT04428658 is sponsored by University of California, Davis. The trial plans to enroll 82 participants.
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