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

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

Detailed Description
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Diagnostic Test: Mellitus GCD59 Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-diabetic pregnant women<br>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<br>* An ELISA for screening for the risk of gestational diabetes<br>* Other names: Mellitus GCD59 ELISA;|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in vitro diagnostic, GDM, gestational diabetes mellitus, screening, pregnancy, prenatal care, women's health