Type 1 Diabetes Telemedicine

NCT03374462 | Completed

• 1 other identifier: 1125857
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

At the conclusion of this project, investigators will have assessed the effectiveness of home-based telemedicine for improving multiple important clinical and patient-centered outcomes in a high-risk pediatric cohort with T1D. Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic. Specifically: A) Patients and families choose to participate in telemedicine visits as a supplement to in-person care; B) Patients and families can utilize secure, internet-based platforms to upload and share glucose meter data and to establish an audio-video connection with a diabetes specialist in their home settings; C) Patients and families are satisfied with the experience of home-based telemedicine and would choose to receive future diabetes care via this modality. Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete more frequent visits with a diabetes specialist than they previously completed via office visits alone. Aim 3. To test the hypothesis that increased contact with a diabetes specialist via home-based telemedicine will lead to significant improvement in glycemic control for these patients. Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based telemedicine on high-cost health care utilization - specifically emergency department (ED) visits and diabetes-related hospitalizations.

Conditions

Diabetes Mellitus, Type 1

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

• Improvement in A1C Levels

  Investigators will compare the mean pre-study and mean post-study A1C levels

  12-months

Secondary Outcomes (4)

• Increased visit frequency

  24-months

• Impact on high-cost health care utilization

  24-months

• Feasibility of home-based telemedicine

  12-months

• Acceptability of home-based telemedicine

  12-months

Study Arms (1)

Telemedicine Intervention

EXPERIMENTAL

All participants will receive the study intervention, which consists of home-based telemedicine visits with a diabetes specialist, at a frequency determined by the patient's degree of glycemic control (every 4, 6, or 8 weeks).

Behavioral: Telemedicine Intervention

Interventions

Telemedicine Intervention BEHAVIORAL

Home-based telemedicine visits

Telemedicine Intervention

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 1-17 years
• known diagnosis of T1D
• \>1 prior visit to the UC Davis Pediatric Endocrinology clinic (to avoid enrolling newly diagnosed patients)
• suboptimal glycemic control, defined as most recent hemoglobin A1C level of \>8%
• access to the internet via a device with video and audio capability (e.g. computer, tablet, mobile phone)
• ability to connect their home glucose meter to an internet-capable device via Bluetooth or physical cable for the purpose of data uploading.

You may not qualify if:

• Patients and parents whose primary language is not English
• Patients who have Western Health Advantage health insurance

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephanie Crossen, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 15, 2017
• Study Start: November 27, 2017
• Primary Completion: April 1, 2019
• Study Completion: October 31, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)