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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04708015
Other study ID # DTX401-CL001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 5, 2020
Est. completion date March 4, 2022

Study information

Verified date May 2024
Source Ultragenyx Pharmaceutical Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to assess the percentage of time patients were in normal glucose control.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 4, 2022
Est. primary completion date March 4, 2022
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Intervention

Other:
No Intervention
A retrospective chart review of medical records

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen
United States UT Health - McGovern Medical School Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Ultragenyx Pharmaceutical Inc

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of time spent in normal glucose control (defined as glucose levels between 70 mg/dL - 120 mg/dL) over a seven-day period 7 days
Secondary Total number of low glycemic events (< 70 mg/dL) over a seven-day period 7 days
Secondary Percentage of time where low glucose values were (< 70mg/dL) over a seven-day period 7 days
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Completed NCT04311307 - Endogenous Glucose Production in Patients With Glycogen Storage Disease Type Ia Phase 1/Phase 2