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



Status:Not yet recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:June 2019
End Date:June 2020
Contact:Laura MacLean
Email:lmaclean@mellitusllc.com
Phone:781-223-1972

Use our guide to learn which trials are right for you!

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)

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.

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
We found this trial at
13
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
Austin, Texas 78758
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials