Clinical trial NCT03374462: Type 1 Diabetes Telemedicine
Official title: Use of Home-Based Telemedicine to Improve Healthcare Utilization and Outcomes in Pediatric Patients With Poorly Controlled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Pediatrics
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 59
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in A1C Levels
timeFrame: 12-months
Secondary outcomes:
measure: Increased visit frequency
timeFrame: 24-months
measure: Impact on high-cost health care utilization
timeFrame: 24-months
measure: Feasibility of home-based telemedicine
timeFrame: 12-months
measure: Acceptability of home-based telemedicine
timeFrame: 12-months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Stephanie Crossen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: