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Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In my pilot study of home-based video visits, 23% of enrolled patients failed to complete their first video visits, effectively withdrawing from the study before receiving any of the intervention."
  • "Synchronous Telehealth Arm: Participants in the synchronous telehealth arm will receive home-based video visits with a pediatric endocrinologist every month for a duration of six months."
  • "Video visits will be conducted using a HIPAA-compliant video conferencing platform."
  • "A single pediatric endocrinologist will conduct all video visits, eliminating any inter-provider variability in clinical approach."
  • "Each video visit will include discussion of interval health events and patient or family concerns, review of shared glucose data and insulin dose information, and provision of recommendations by the physician."
  • "They will receive usual care at the UCD Pediatric Diabetes Clinic, which typically includes at least quarterly in-person and/or telehealth visits, as well as the option to share data with the diabetes clinic team at any point between visits and contact providers for feedback or assistance as needed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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)

Study sites (1)

CA