Type 1 Diabetes Telemedicine | NCT03374462

Studies
Type 1 Diabetes Telemedicine

NCT03374462

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Feb 21, 2020Actual

Enrollment

59Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2017Actual

Primary Completion Date

Apr 1, 2019Actual

Completion Date

Oct 31, 2019Actual

First Submitted Date

Nov 27, 2017

First Submission Date that Met QC Criteria

Dec 11, 2017

First Posted Date

Dec 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Telemedicine Intervention	Behavioral	Home-based telemedicine visits	Telemedicine Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in A1C Levels	Investigators will compare the mean pre-study and mean post-study A1C levels	12-months

Secondary Outcomes

Measure	Description	Time Frame
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
Impact on high-cost health care utilization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephanie Crossen, MD, MPH	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California-Davis		Sacramento	California	95817	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided