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Active, not recruitingNCT03968055Updated May 8, 2026

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

An interventional study of Integration with Epic in Type 1 Diabetes, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to participants aged 6 Months to 21 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
6 Months to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • pediatrics
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • OtherIntegration 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)

    Also known as: GluVue Platform

06

What researchers measure

Primary outcomes

  1. Contacts with the care provider

    Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring

    Time frame: 1 year

Secondary outcomes

  1. Hemoglobin A1c

    Prospective chart review for lab values

    Time frame: 1 year

07

Study locations

1 site
  • Lucile Packard Children's Hospital
    Palo Alto, California 94305, United States
08

References and documents

Publications

  • Prahalad P, Ding VY, Zaharieva DP, Addala A, Johari R, Scheinker D, Desai M, Hood K, Maahs DM. Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Type 1 Diabetes: the Pilot 4T Study. J Clin Endocrinol Metab. 2022 Mar 24;107(4):998-1008. doi: 10.1210/clinem/dgab859. PubMed 34850024 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03968055
Lead sponsor
Stanford University
Responsible party
Priya Prahalad (Clinical Assistant Professor, Stanford University) — Principal investigator
First posted
May 30, 2019
Start date
Mar 25, 2019
Primary completion
Dec 30, 2025
Completion
Dec 30, 2028 (estimated)
Last update
May 8, 2026

Study contacts

Priya Prahalad, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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