Back to resultsRemote Monitoring of CGM Data in Pediatric Patients With Newly Diagnosed Type 1 Diabetes (T1D)
Primary Purpose
Type 1 Diabetes
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integration with Epic
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring pediatrics
Eligibility 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
Sites / Locations
- Lucile Packard Children's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with Type 1 Diabetes
Arm Description
Participants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team.
Outcomes
Primary Outcome Measures
Contacts with the care provider
Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring
Secondary Outcome Measures
Hemoglobin A1c
Prospective chart review for lab values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03968055
Brief Title
Remote Monitoring of CGM Data in Pediatric Patients With Newly Diagnosed Type 1 Diabetes (T1D)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
pediatrics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Type 1 Diabetes
Arm Type
Other
Arm Description
Participants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team.
Intervention Type
Other
Intervention Name(s)
Integration with Epic
Other Intervention Name(s)
GluVue Platform
Intervention Description
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)
Primary Outcome Measure Information:
Title
Contacts with the care provider
Description
Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Prospective chart review for lab values
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Prahalad, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34850024
Citation
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.
Results Reference
derived
Learn more about this trial
Remote Monitoring of CGM Data in Pediatric Patients With Newly Diagnosed Type 1 Diabetes (T1D)
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