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)

Study Description

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Brief Summary:

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 or disease
Diabetes, Gestational

Detailed Description:

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.

Study Design

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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

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pregnant women between 18 & 50 years old who are having a 3 hour GTT as directed by their doctor

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0526

Sponsors and Collaborators

University of Cincinnati

Investigators

Principal Investigator:	Ronald Jaekle, MD	University of Cincinnati

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Harlass FE, Brady K, Read JA. Reproducibility of the oral glucose tolerance test in pregnancy. Am J Obstet Gynecol. 1991 Feb;164(2):564-8.

Melki V, Ayon F, Fernandez M, Hanaire-Broutin H. Value and limitations of the Continuous Glucose Monitoring System in the management of type 1 diabetes. Diabetes Metab. 2006 Apr;32(2):123-9. Review.

Rivers SM, Kane MP, Bakst G, Busch RS, Hamilton RA. Precision and accuracy of two blood glucose meters: FreeStyle Flash versus One Touch Ultra. Am J Health Syst Pharm. 2006 Aug 1;63(15):1411-6.

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
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