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

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ClinicalTrials.gov Identifier: NCT04708015
Recruitment Status : Enrolling by invitation
First Posted : January 13, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Ultragenyx Pharmaceutical Inc

Study Description
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Brief Summary:
The primary objective of this study is to assess the percentage of time patients were in normal glucose control.

Condition or disease Intervention/treatment
Glycogen Storage Disease Type IA Other: No Intervention

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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)
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No Intervention
    A retrospective chart review of medical records

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients eight years of age and older with GSDIa, who have used the Dexcom G6 iCGM for glycemic control, and with at least one month of CGM data available on the Dexcom Clarity cloud.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708015


Locations
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United States, Texas
UT Health - McGovern Medical School
Houston, Texas, United States, 77030
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
Ultragenyx Pharmaceutical Inc
Investigators
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Study Director: Medical Director Ultragenyx Pharmaceutical Inc
More Information
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Responsible Party: Ultragenyx Pharmaceutical Inc
ClinicalTrials.gov Identifier: NCT04708015    
Other Study ID Numbers: DTX401-CL001
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Keywords provided by Ultragenyx Pharmaceutical Inc:
Dexcom G6 iCGM
glucose metabolism disorder
CGM
Continuous Glucose Monitoring
Additional relevant MeSH terms:
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Glycogen Storage Disease
Glycogen Storage Disease Type I
Metabolic Diseases
 Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn