Type 1 Diabetes Telemedicine

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Telemedicine Intervention

• Registration Number: NCT03374462
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-15
• Primary Completion: 2019-04-01
• Study Completion: 2019-10-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• 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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedicine Intervention	Telemedicine Intervention	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).

Primary Outcome Measures

Name	Time	Method
Improvement in A1C Levels	12-months	Investigators will compare the mean pre-study and mean post-study A1C levels

Secondary Outcome Measures

Name	Time	Method
Increased visit frequency	24-months	Investigators will evaluate if offering telemedicine visits leads to increased visit frequency for these patients during the 12-month study period, when compared to the previous 12-months
Impact on high-cost health care utilization	24-months	Investigators will compare the mean number of ED visits and mean number of diabetes-related hospitalizations for patients in the cohort
Acceptability of home-based telemedicine	12-months	Investigators will evaluate the acceptability of home-based telemedicine for the patient population by the percent of those completing the study who express satisfaction with the telemedicine experience.
Feasibility of home-based telemedicine	12-months	Investigators will evaluate the feasibility of home-based telemedicine for the patient population by the percent of eligible patients who enroll in the study and the percent of enrolled patients who complete the study

Trial Locations

Locations (1)

University of California-Davis; 🇺🇸 Sacramento, California, United States