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

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ClinicalTrials.gov Identifier: NCT03968055
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Priya Prahalad, 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. 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Integration with Epic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1


Intervention Details:
  • 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 Name: GluVue Platform


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 1 year ]
    Prospective chart review for lab values



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968055


Contacts
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Contact: Priya Prahalad, MD, PhD 650-721-1811 prahalad@stanford.edu
Contact: Ma Agnes Ith 50-497-4123 mith@stanford.edu

Locations
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United States, California
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94305
Contact: Priya Prahalad, MD, PhD    650-721-1811    prahalad@stanford.edu   
Sponsors and Collaborators
Stanford University

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Responsible Party: Priya Prahalad, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03968055     History of Changes
Other Study ID Numbers: 48935
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Priya Prahalad, Stanford University:
pediatrics

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases