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

• Sponsor: Mellitus, LLC (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT03865901
• Collaborator: Regulatory and Clinical Research Institute Inc (Other)
• Enrollment: 0
• Locations: 19
• Anticipated Duration (Months): 16.1
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes	Diagnostic Test: Mellitus GCD59 Test

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
• Anticipated Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Non-diabetic pregnant women Non-diabetic women with singleton pregnancy undergoing screening for gestational diabetes who provide plasma samples for testing with the Mellitus GCD59 Test	Diagnostic Test: Mellitus GCD59 Test; An ELISA for screening for the risk of gestational diabetes; Other Names: Mellitus GCD59 ELISA

Outcome Measures

Primary Outcome Measures

1. Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening [The 24-28th gestational week of singleton pregnancy]

   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)

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

Other Outcome Measures

1. 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]

2. Sensitivity and specificity of the GCD59 ELISA across relevant subgroups [The 24-28th gestational week of singleton pregnancy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	UC Irvine Health	Orange	California	United States	92868
3	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
4	Christina Care Health System	Newark	Delaware	United States	19713
5	Johns Hopkins University	Baltimore	Maryland	United States	21287
6	Boston Medical Center	Boston	Massachusetts	United States	02118
7	UMass Medical School/UMass Memorial Health Care	Worcester	Massachusetts	United States	01605
8	Spectrum Hleath	Grand Rapids	Michigan	United States	49503
9	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina	United States	27599
10	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
11	Ohio State University School of Medicine	Columbus	Ohio	United States	43209
12	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	Greenville Health System	Greenville	South Carolina	United States	29605
14	Austin Maternal-Fetal Medicine	Austin	Texas	United States	78758
15	University of Texas Medical Branch	Galveston	Texas	United States	77555
16	Baylor College of Medicine	Houston	Texas	United States	77401
17	University of Texas Health Science Center, San Antonio	San Antonio	Texas	United States	78207
18	University of Utah School of Medicine	Salt Lake City	Utah	United States	84132
19	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Mellitus, LLC
• Regulatory and Clinical Research Institute Inc

Investigators

• Study Chair: Joyce A Lonergan, Mellitus, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mellitus, LLC
• ClinicalTrials.gov Identifier: NCT03865901
• Other Study ID Numbers: CSP-MEL-002
• First Posted: Mar 7, 2019
• Last Update Posted: Sep 17, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Mellitus, LLC: in vitro diagnostic; GDM; gestational diabetes mellitus; screening; pregnancy; prenatal care; women's health
• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus

Study Results

No Results Posted as of Sep 17, 2019