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Completed

NCT Number: NCT01074489

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)

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267-0526, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Blood glucose levels

    Time frame: Over 1 week

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Challenging the Gold Standard: A Pilot Study Comparing CGMS and Capillary Glucose Monitors Versus 3 Hour GTT to Diagnose Gestational Diabetes Mellitus

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2010
Registry last updated
Aug 25, 2015

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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