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Completed

NCT Number: NCT04708015

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

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

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen, Groningen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

A retrospective chart review of medical records

Primary outcomes

  1. Percentage of time spent in normal glucose control (defined as glucose levels between 70 mg/dL - 120 mg/dL) over a seven-day period

    Time frame: 7 days

Secondary outcomes

  1. Total number of low glycemic events (< 70 mg/dL) over a seven-day period

    Time frame: 7 days

  2. Percentage of time where low glucose values were (< 70mg/dL) over a seven-day period

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Ultragenyx Pharmaceutical Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2021
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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