Gestational Diabetes
Conditions
Keywords
in vitro diagnostic, GDM, gestational diabetes mellitus, screening, pregnancy, prenatal care, women's health
Brief summary
Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)
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.
Interventions
DIAGNOSTIC_TESTMellitus GCD59 Test
An ELISA for screening for the risk of gestational diabetes
Sponsors
Regulatory and Clinical Research Institute Inc
Mellitus, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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
| 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 |
Countries
United States
Outcome results
None listed