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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Gestational Diabetes
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • Orange, California, United States, 92868
      • UC Irvine Health
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christina Care Health System
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Worcester, Massachusetts, United States, 01605
      • UMass Medical School/UMass Memorial Health Care
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Hleath
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43209
      • Ohio State University School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Texas
    • Austin, Texas, United States, 78758
      • Austin Maternal-Fetal Medicine
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77401
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78207
      • University of Texas Health Science Center, San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah School of Medicine
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Nondiabetic women with a singleton pregnancy recommended for routine GDM screening between 24-28 weeks gestation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
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

Outcome Measure	Time Frame
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
Sensitivity and specificity of the GCD59 ELISA across relevant subgroups	The 24-28th gestational week of singleton pregnancy

Collaborators and Investigators

• Sponsor: Mellitus, LLC
• Collaborators: Regulatory and Clinical Research Institute Inc
• Investigators: Study Chair: Joyce A Lonergan, Mellitus, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pregnancy; screening; GDM; women's health; gestational diabetes mellitus; prenatal care; in vitro diagnostic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: CSP-MEL-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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