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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04428658
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Supplemental video visits — BEHAVIORAL
    Receiving home-based video visits with a pediatric endocrinologist monthly as a supplement to regular diabetes clinic visits.
  • Standard of Care — BEHAVIORAL
    Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
  • Supplemental remote monitoring — BEHAVIORAL
    Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.

Study Details

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.

Key Dates

Start date
Sep 15, 2022
Status verified
Mar 2025
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Supplemental video visits
    Participants in this intervention arm will receive home-based video visits with a pediatric endocrinologist every month for the duration of 6 months in addition to usual care.
  • Active Comparator: Standard of Care
    The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic.
  • Experimental: Supplemental remote monitoring
    Participants in this intervention arm will receive remote glucose monitoring with monthly asynchronous outreach from a pediatric endocrinologist for a duration of six months in addition to usual care.

Primary Outcome Measure

Glycemic control [ Time Frame: 6 months - baseline to study completion ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California-DavisSacramentoCalifornia95817
Salvador Lopez, BA
[email protected]
916-734-4476
Christine Feller RD CCRP, BS, BA
[email protected]
Stephanie Crossen, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California-Davis· Sacramento, CA

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