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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Purpose
The purpose of this research study is to compare 3 methods of measuring blood glucose (blood sugar) levels to see if the finger-stick method or the continuous glucose monitoring system is better than or as good as the 3 hour glucose tolerance test (GTT) for the diagnosis of gestational diabetes.
| Condition |
|---|
|
Diabetes, Gestational |
| Study Type: | Observational |
| Study Design: | 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 |
- Blood glucose levels [ Time Frame: Over 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
The rate of gestational diabetes and fetal macrosomia is increasing. Moreover, it appears that many macrosomic infants are born to non-diabetic mothers. However, this presents the question of whether our current accepted means of diagnosis is reflecting the true prevalence of GDM. The 3-hour GTT measures glycemic control over a limited period of time. A more prolonged period of monitoring makes more physiologic sense, as it would paint a picture of a patient's overall trend before a diagnosis can be confirmed or excluded. Given the ability of the CGMS and capillary glucose monitor to follow glycemic trends over an extended time period, these methods may prove more effective at identifying patients with abnormal glucose tolerance. As these modalities test the patients in their native environments, the effect of dietary changes prior to the testing period may be minimized, potentially providing an more accurate assessment of abnormal glucose utilization. Furthermore, both modalities should be more cost-effective than the 3- hour GTT.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pregnant women between 18 & 50 years old who are having a 3 hour GTT as directed by their doctor
Inclusion Criteria:
- Pregnant patients seen in the Center for Women's Health at University Hospital in Cincinnati, OH between 24-28 weeks gestation
- One hour 50-g 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
Contacts and Locations| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0526 | |
| Principal Investigator: | Ronald Jaekle, MD | University of Cincinnati |
More Information
Publications:
| Responsible Party: | Ronadl Jaekle, MD, University of Cincinanti |
| ClinicalTrials.gov Identifier: | NCT01074489 History of Changes |
| Other Study ID Numbers: | GDM Gold 1 |
| Study First Received: | February 22, 2010 |
| Last Updated: | February 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 19, 2013