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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ronald Jaekle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01074489
First received: February 22, 2010
Last updated: May 25, 2014
Last verified: February 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074489

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

Publications:
Responsible Party: Ronald Jaekle, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01074489     History of Changes
Other Study ID Numbers: GDM Gold 1
Study First Received: February 22, 2010
Last Updated: May 25, 2014
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 September 18, 2014