NCT04708015

Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa

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
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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, cornstarch/Glycosade use and demographic data directly, if available, from the medical charts and will enter this information into an electronic data capture (EDC) system.

Conditions

• Glycogen Storage Disease Type IA

Interventions

Type	Name	Description
OTHER	No Intervention	A retrospective chart review of medical records

Timeline

• Start date: 2020-11-05
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2021-01-13
• Last updated: 2024-05-29

Locations

2 sites across 2 countries: United States, Netherlands