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

April 19, 2024 updated by: Priya Prahalad, Stanford University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Lucile Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with Type 1 Diabetes
Participants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team.
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)
Other Names:
  • GluVue Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contacts with the care provider
Time Frame: 1 year
Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 1 year
Prospective chart review for lab values
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Priya Prahalad, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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