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)
August 21, 2015 updated by: Ronald Jaekle, University of Cincinnati
Challenging the Gold Standard: A Pilot Study Comparing CGMS and Capillary Glucose Monitors Versus 3 Hour GTT to Diagnose Gestational Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45267-0526
- University of Cincinnati
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood glucose levels
Time Frame: Over 1 week
|
Over 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Jaekle, MD, University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/s0002-9378(11)80021-9.
- 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. doi: 10.1016/s1262-3636(07)70258-6.
- 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. doi: 10.2146/ajhp050473.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 22, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (Estimate)
February 24, 2010
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 21, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GDM Gold 1
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