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

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Other: Integration with Epic

• Registration Number: NCT03968055
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patients with Type 1 Diabetes	Integration with Epic	Participants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team.

Primary Outcome Measures

Name	Time	Method
Contacts with the care provider	1 year	Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	1 year	Prospective chart review for lab values

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States