Study Stopped
Further product development is needed prior to clinical study testing
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
1 other identifier
observational
N/A
1 country
19
Brief Summary
Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2019
19 active sites
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
First Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 17, 2019
September 1, 2019
1 year
March 5, 2019
September 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 Outcomes (2)
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
Study Arms (1)
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
Interventions
An ELISA for screening for the risk of gestational diabetes
Eligibility Criteria
Nondiabetic women with a singleton pregnancy recommended for routine GDM screening between 24-28 weeks gestation
You may qualify if:
- Women 18 years of age or older at enrollment
- Has an established viable singleton pregnancy
- Is recommended for routine GDM screening between 24-28 weeks gestation
- Has confirmed gestational age of 24-28 weeks at the Screening Visit
- Is willing and able to provide documentation of informed consent
You may not qualify if:
- Has diabetes before pregnancy or has already been diagnosed with GDM
- Has contraindications for drinking oral glucose solution up to 100 g of sugar
- Is taking metformin for any reason
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mellitus, LLClead
- Regulatory and Clinical Research Institute Inccollaborator
Study Sites (19)
University of Alabama
Birmingham, Alabama, 35294, United States
UC Irvine Health
Orange, California, 92868, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Christina Care Health System
Newark, Delaware, 19713, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
UMass Medical School/UMass Memorial Health Care
Worcester, Massachusetts, 01605, United States
Spectrum Hleath
Grand Rapids, Michigan, 49503, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University School of Medicine
Columbus, Ohio, 43209, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
Austin Maternal-Fetal Medicine
Austin, Texas, 78758, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Baylor College of Medicine
Houston, Texas, 77401, United States
University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78207, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joyce A Lonergan
Mellitus, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 7, 2019
Study Start
May 1, 2019
Primary Completion
May 1, 2020
Study Completion
September 1, 2020
Last Updated
September 17, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share