Challenging the Gold Standard: Pilot Study Comparing Continuous Glucose Monitoring System (CGMS), Capillary Glucose Monitors and 3 Hour Glucose Tolerance Test (GTT) to Diagnose Gestational Diabetes Mellitus (GDM)
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ClinicalTrials.gov Identifier: NCT01074489 |
Recruitment Status
:
Completed
First Posted
: February 24, 2010
Last Update Posted
: August 25, 2015
|
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Condition or disease |
---|
Diabetes, Gestational |
Study Type : | Observational |
Actual Enrollment : | 7 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Challenging the Gold Standard: A Pilot Study Comparing CGMS and Capillary Glucose Monitors Versus 3 Hour GTT to Diagnose Gestational Diabetes Mellitus |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

- Blood glucose levels [ Time Frame: Over 1 week ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Pregnant patients seen in the Center for Women's Health at University Hospital in Cincinnati, Ohio between 24-28 weeks gestation
- One hour 50-g Glucose Challenge Test (GCT) value greater than 130 mg/dL.
Exclusion Criteria:
- Patients with known diabetes mellitus
- Patients receiving steroids or oral terbutaline therapy
- Patients entering prenatal care later than 20 weeks gestation

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): NCT01074489
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0526 |
Principal Investigator: | Ronald Jaekle, MD | University of Cincinnati |
Publications:
Responsible Party: | Ronald Jaekle, Professor, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT01074489 History of Changes |
Other Study ID Numbers: |
GDM Gold 1 |
First Posted: | February 24, 2010 Key Record Dates |
Last Update Posted: | August 25, 2015 |
Last Verified: | August 2015 |
Keywords provided by Ronald Jaekle, University of Cincinnati:
GDM Gestational Diabetes GTT CGMS |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |