Gestational DiabetesNCT03865901
Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening
An observational study of Gestational Diabetes, run by Mellitus, LLC at 19 sites in United States.
Trial summary
Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Mellitus GCD59 Test
- How many people
- 0 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2019to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Nondiabetic women with a singleton pregnancy recommended for routine GDM screening between 24-28 weeks gestation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Austin Maternal-Fetal Medicine
Austin, Texas, 78758
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 35294
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
MetroHealth Medical Center
Cleveland, Ohio, 44109
Ohio State University School of Medicine
Columbus, Ohio, 43209
University of Texas Medical Branch
Galveston, Texas, 77555
Spectrum Hleath
Grand Rapids, Michigan, 49503
Greenville Health System
Greenville, South Carolina, 29605
Baylor College of Medicine
Houston, Texas, 77401
Christina Care Health System
Newark, Delaware, 19713
Eastern Virginia Medical School
Norfolk, Virginia, 23507
UC Irvine Health
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah School of Medicine
Salt Lake City, Utah, 84132
University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78207
UMass Medical School/UMass Memorial Health Care
Worcester, Massachusetts, 01605
About this study
Official title: 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)
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Mellitus GCD59 Test
- Keywords
- in vitro diagnostic, GDM, gestational diabetes mellitus, screening, pregnancy, prenatal care, women's health
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mellitus GCD59 TestDiagnostic test
Also called Mellitus GCD59 ELISA
An ELISA for screening for the risk of gestational diabetes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Mellitus GCD59 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: The 24-28th gestational week of singleton pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Further product development is needed prior to clinical study testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mellitus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Responsible party
- Sponsor
- Investigators
- Joyce A Lonergan, Study chair, Mellitus, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865901
- Sponsor's protocol ID
- CSP-MEL-002
- Status last verified
- Sep 2019
- First submitted
- 5 Mar 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
- ClinicalTrials.gov ID
- NCT03865901
- Acronym / sponsor ID
- CSP-MEL-002
- Conditions
- Gestational Diabetes
- Keywords
- in vitro diagnostic, GDM, gestational diabetes mellitus, screening, pregnancy, prenatal care, women's health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Further product development is needed prior to clinical study testing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mellitus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Study start
- May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic pregnant women | – | Diagnostic Test: Mellitus GCD59 TestNon-diabetic women with singleton pregnancy undergoing screening for gestational diabetes who provide plasma samples for testing with the Mellitus GCD59 Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nondiabetic women with a singleton pregnancy recommended for routine GDM screening between 24-28 weeks gestation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mellitus GCD59 TestAlso: Mellitus GCD59 ELISAAn ELISA for screening for the risk of gestational diabetes | Diagnostic test | Non-diabetic pregnant women |
Primary outcome
Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening
Time frame: 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)
3 secondary outcomes
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)
Time frame: 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
Time frame: 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
Time frame: The 24-28th gestational week of singleton pregnancy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce A Lonergan study chair
Mellitus, LLC
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Mellitus, LLC at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening (time frame: The 24-28th gestational week of singleton pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.