Recruiting

Telehealth Intervention

Sponsor:

UCLA

Code:

NCT04428658

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Supplemental video visits

Standard of Care

Supplemental remote monitoring

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT04428658

Start date

Sep 15, 2022

Status verified date

Mar, 2025

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Supplemental video visits

Receiving home-based video visits with a pediatric endocrinologist monthly as a supplement to regular diabetes clinic visits.

Standard of Care

Usual quarterly visits with the UCD Pediatric Diabetes Clinic.

Supplemental remote monitoring

Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.

Primary outcome measure

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

Central Contacts and Locations

Locations

University of California-Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Salvador Lopez, BA

916-734-4476salo@ucdavis.edu

Christine Feller RD CCRP, BS, BA

cfeller@ucdavis.edu

Principal Investigator:

Stephanie Crossen, MD, MPH

More Information

Sponsor

University of California, Davis

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-03-27.