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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Integration with Epic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Type 1 Diabetes<br>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<br>* 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)<br>* Other names: GluVue Platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics