Remote Monitoring of CGM Data in Pediatric Patients With Newly Diagnosed Type 1 Diabetes (T1D)
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2019
CompletedFirst Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
ExpectedMay 8, 2026
May 1, 2026
6.8 years
May 28, 2019
May 5, 2026
Conditions
Keywords
Outcome Measures
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
1 year
Secondary Outcomes (1)
Hemoglobin A1c
1 year
Study Arms (1)
Patients with Type 1 Diabetes
OTHERParticipants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucile Packard Children's Hospital
Palo Alto, California, 94305, United States
Related Publications (1)
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.
PMID: 34850024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Priya Prahalad, MD, PhD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
May 28, 2019
First Posted
May 30, 2019
Study Start
March 25, 2019
Primary Completion
December 30, 2025
Study Completion (Estimated)
December 30, 2028
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share