Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708015
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2021-01-11
Brief Title:
Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa
Sponsor:
Ultragenyx Pharmaceutical Inc
Organization:
Ultragenyx Pharmaceutical Inc
Study Overview
Official Title:
A Retrospective Observational Clinical Study on the Use of Continuous Glucose Monitoring for Glycemic Control in Adult and Pediatric Patients With Glycogen Storage Disease Type Ia GSDIa
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 organization CRO to review prior to sending to the Sponsor for analysis of glycemic control The CRO will ensure data shared with the Sponsor is de-identified and transferred over a secure file transfer platform Further Remote Site Specialists RSSs from the CRO will work with the healthcare providers HCPs from participating sites to obtain additional patient data including medical history prescribed diet cornstarchGlycosade use and demographic data directly if available from the medical charts and will enter this information into an electronic data capture EDC system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None