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)
1 other identifier
observational
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 25, 2015
August 1, 2015
4.8 years
February 22, 2010
August 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood glucose levels
Over 1 week
Eligibility Criteria
Pregnant women between 18 \& 50 years old who are having a 3 hour GTT as directed by their doctor
You may qualify if:
- 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.
You may not qualify if:
- Patients with known diabetes mellitus
- Patients receiving steroids or oral terbutaline therapy
- Patients entering prenatal care later than 20 weeks gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45267-0526, United States
Related Publications (3)
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.
PMID: 1992702BACKGROUNDMelki 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.
PMID: 16735960BACKGROUNDRivers 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.
PMID: 16849704BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Jaekle, MD
University of Cincinnati
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 24, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 25, 2015
Record last verified: 2015-08