Type 1 Diabetes Telemedicine

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Use of Home-Based Telemedicine to Improve Healthcare Utilization and Outcomes in Pediatric Patients With Poorly Controlled Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374462
• Other study ID #: 1125857
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 31, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Exclusion Criteria:

• Patients and parents whose primary language is not English

• Patients who have Western Health Advantage health insurance

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Telemedicine Intervention
Home-based telemedicine visits

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in A1C Levels	Investigators will compare the mean pre-study and mean post-study A1C levels	12-months
Secondary	Increased visit frequency	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	24-months
Secondary	Impact on high-cost health care utilization	Investigators will compare the mean number of ED visits and mean number of diabetes-related hospitalizations for patients in the cohort	24-months
Secondary	Feasibility of home-based telemedicine	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	12-months
Secondary	Acceptability of home-based telemedicine	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.	12-months