Status:
COMPLETED
Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa
Lead Sponsor:
Ultragenyx Pharmaceutical Inc
Conditions:
Glycogen Storage Disease Type IA
Eligibility:
All Genders
8+ years
Brief Summary
The primary objective of this study is to assess the percentage of time patients were in normal glucose control.
Detailed Description
Retrospective Dexcom G6 iCGM data stored in the Clarity cloud from eligible patients will be accessed and downloaded, stripped of patient-identifying information and provided to the contract research ...
Eligibility Criteria
Inclusion
- Diagnosis of GSDIa confirmed by either liver biopsy or molecular testing.
- Currently using the Dexcom G6 iCGM for glycemic control and with approximately one (1) month of CGM data available on the Dexcom Clarity cloud and have authorized sharing of data with thereferral center through the Dexcom Clarity app.
Exclusion
- Presence or history of any disease, condition or chronic medication that, in the Investigator's opinion, would significantly affect interpretation of study results.
- Use of any investigational product or investigational medical device within 30 calendar days preceding screening or before completion of all scheduled study assessments during study enrollment.
Key Trial Info
Start Date :
November 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 4 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04708015
Start Date
November 5 2020
End Date
March 4 2022
Last Update
May 29 2024
Active Locations (2)
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1
UT Health - McGovern Medical School
Houston, Texas, United States, 77030
2
University Medical Center Groningen
Groningen, Netherlands, 9700 RB