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NCT03968055 Clinical Trial

Remote Monitoring of CGM Data in Pediatric Patients With Newly Diagnosed Type 1 Diabetes (T1D)

Type 1 Diabetes Clinical Trial

Official title:
The Use of Continuous Glucose Monitor Technology and Remote Monitoring to Change Clinical Outcomes Following New Diagnosis of Type 1 Diabetes in the Pediatric Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03968055
Other study ID # 48935
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 25, 2019
Est. completion date June 1, 2024

Study information
Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data.

Description:

Based on alerts from GluVue, care team members will proactively reach out to patients and their families for more frequent dose adjustments. We will assess if remote monitoring facilitates contact between the care team and patients and improves glycemic control.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 21 Years
Eligibility Inclusion Criteria: - All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic - Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic - Individuals who agree to CGM data integration into the electronic medical record (EMR) for remote monitoring - Age: birth to < 21 years of age Exclusion Criteria: - Diabetes diagnosis other than T1D - Diagnosis of diabetes > 1 month prior to initial visit - Individuals with the intention of obtaining diabetes care at another clinic - Individuals who do not consent to CGM use, CGM data integration, or remote monitoring - Individuals > 21 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Integration with Epic
Participants will have CGM data connected to our medical record through an already established pathway (Dexcom app on iOS device to Apple HealthKit to Epic MyChart to Epic)

Locations
Country Name City State
United States Lucile Packard Children's Hospital Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Contacts with the care provider Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring 1 year
Secondary Hemoglobin A1c Prospective chart review for lab values 1 year
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