search
Back to results

Type 1 Diabetes Telemedicine

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine Intervention
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 1 focused on measuring Pediatrics

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California-Davis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telemedicine Intervention

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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.

Full Information

First Posted
November 27, 2017
Last Updated
February 19, 2020
Sponsor
University of California, Davis
search

1. Study Identification

Unique Protocol Identification Number
NCT03374462
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Pediatrics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine Intervention
Intervention Description
Home-based telemedicine visits
Primary Outcome Measure Information:
Title
Improvement in A1C Levels
Description
Investigators will compare the mean pre-study and mean post-study A1C levels
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Increased visit frequency
Description
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
Time Frame
24-months
Title
Impact on high-cost health care utilization
Description
Investigators will compare the mean number of ED visits and mean number of diabetes-related hospitalizations for patients in the cohort
Time Frame
24-months
Title
Feasibility of home-based telemedicine
Description
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
Time Frame
12-months
Title
Acceptability of home-based telemedicine
Description
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.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Crossen, MD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Type 1 Diabetes Telemedicine

We'll reach out to this number within 24 hrs