Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening

Gestational Diabetes Clinical Trial

Official title:

Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03865901
• Other study ID #: CSP-MEL-002
• Status: Withdrawn
• Start date: May 2019
• Est. completion date: September 2020

Study information

• Verified date: September 2019
• Source: Mellitus, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)

Description:

Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value (NPV) and positive predictive value (PPV) to identify pregnant women at risk for GDM. Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women 18 years of age or older at enrollment

2. Has an established viable singleton pregnancy

3. Is recommended for routine GDM screening between 24-28 weeks gestation

4. Has confirmed gestational age of 24-28 weeks at the Screening Visit

5. Is willing and able to provide documentation of informed consent

Exclusion Criteria:

1. Has diabetes before pregnancy or has already been diagnosed with GDM

2. Has contraindications for drinking oral glucose solution up to 100 g of sugar

3. Is taking metformin for any reason

4. Has any concomitant illness, disease or condition that, in the clinical judgment of the investigator, is likely to prevent the subject from complying with any aspect of the protocol, or that may put the subject at unacceptable risk

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• Mellitus GCD59 Test
An ELISA for screening for the risk of gestational diabetes

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Austin Maternal-Fetal Medicine	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Ohio State University School of Medicine	Columbus	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Spectrum Hleath	Grand Rapids	Michigan
United States	Greenville Health System	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Christina Care Health System	Newark	Delaware
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	UC Irvine Health	Orange	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	University of Texas Health Science Center, San Antonio	San Antonio	Texas
United States	UMass Medical School/UMass Memorial Health Care	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mellitus, LLC	Regulatory and Clinical Research Institute Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Negative predictive value (NPV) and positive predictive value (PPV) of the GCD59 ELISA for a range of gestational diabetes mellitus (GDM) prevalence values likely to be encountered in clinical practice in the United States		The 24-28th gestational week of singleton pregnancy
Other	Sensitivity and specificity of the GCD59 ELISA across relevant subgroups		The 24-28th gestational week of singleton pregnancy
Primary	Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening	NPV and PPV will be based on two or more abnormal oral glucose tolerance test (OGTT) results (abnormal for OGTT as defined by Carpenter and Coustan diagnostic criteria)	The 24-28th gestational week of singleton pregnancy
Secondary	Sensitivity and specificity of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening, using two or more abnormal OGTT results (abnormal for OGTT as defined by Carpenter and Coustan diagnostic criteria)		The 24-28th gestational week of singleton pregnancy
Secondary	NPV, PPV, sensitivity and specificity of the GCD59 ELISA for the risk of GDM using one or more abnormal OGTT results		The 24-28th gestational week of singleton pregnancy
Secondary	Sensitivity and specificity of the GCD59 ELISA to that of glucose load test (GLT) using two or more abnormal oral glucose tolerance test (OGTT) results		The 24-28th gestational week of singleton pregnancy