NCT04708015

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

January 11, 2021

Last Update Submit

May 24, 2024

Conditions

Glycogen Storage Disease Type IA

Keywords

Dexcom G6 iCGMglucose metabolism disorderCGMContinuous Glucose Monitoring

Outcome Measures

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

    7 days

Secondary Outcomes (2)

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

    7 days

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

    7 days

Interventions

No InterventionOTHER

A retrospective chart review of medical records

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Health - McGovern Medical School

Houston, Texas, 77030, United States

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Hepatorenal form of glycogen storage diseaseGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Director

    Ultragenyx Pharmaceutical Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

November 5, 2020

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

NL(1)US(1)