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

NCT04428658 | Recruiting

• 1 other identifier: 1616262
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Mean change in Hemoglobin A1C from enrollment to study completion

  6 months - baseline to study completion

Secondary Outcomes (2)

• Healthcare utilization

  6 months prior to study; 6 months during study

• Patient-reported outcomes

  6 months - baseline and study completion

Study Arms (3)

Supplemental video visits

EXPERIMENTAL

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.

Behavioral: Supplemental video visits; Behavioral: Standard of Care

Standard of Care

ACTIVE COMPARATOR

The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic.

Behavioral: Standard of Care

Supplemental remote monitoring

EXPERIMENTAL

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.

Behavioral: Standard of Care; Behavioral: Supplemental remote monitoring

Interventions

Supplemental video visits BEHAVIORAL

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

Supplemental video visits

Standard of Care BEHAVIORAL

Usual quarterly visits with the UCD Pediatric Diabetes Clinic.

Standard of Care; Supplemental remote monitoring; Supplemental video visits

Supplemental remote monitoring BEHAVIORAL

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

Supplemental remote monitoring

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: September 15, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)