Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

NCT05491954 | Unknown FDA Device

• 1 other identifier: 2021H0009
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Changes in glycemic control over late gestation as measured by A1c

  Assessed by changes in glycemic control over late gestation as measured by HbA1c at the time of enrollment and delivery

  9 months

Secondary Outcomes (1)

• The number of neonatal hypoglycemic episodes

  1 week

Study Arms (4)

Euglycemic

Women who pass a 50g GCT with 1-hour glucose \<135 mg/dL

Device: Dexcom G6

Possible glucose intolerance

Women who fail a 50g GCT (1-hour glucose \>135 mg/dL) and have 0/4 abnormal values on a 100g oral glucose tolerance test (OGTT) by Carpenter-Coustan values

Device: Dexcom G6

Confirmed glucose intolerance

Women who fail a 50g GCT (1-hour glucose \>135 mg/dL) and have 1/4 abnormal values on 100g GTT test by Carpenter-Coustan values

Device: Dexcom G6

Gestational Diabetes Mellitus

Women who fail a 50g GCT (1-hour glucose \>135 mg/dL) and have ≥2/4 abnormal values on 100g GTT test by Carpenter-Coustan values (Table 1), meeting criteria for GDM

Device: Dexcom G6

Interventions

Dexcom G6 DEVICE

Continuous glucose monitoring

Confirmed glucose intolerance; Euglycemic; Gestational Diabetes Mellitus; Possible glucose intolerance

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women ages 18-45 living in central Ohio living with or without gestational diabetes mellitus

You may qualify if:

• Age 18-45 years
• Women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
• Planning to deliver at OSU Wexner Medical Center
• Able to understand the study, and having understood, provide written informed consent in English

You may not qualify if:

• Abnormal early 50g GCT screen, thereby necessitating 100g OGTT at 24-28 weeks
• Known pregestational diabetes (type 1, type 2, MODY)
• g GCT \>200 mg/dl leading to GDM diagnosis without the performance of 3hr 100g GTT
• Abnormal obstetrical ultrasound suspicious for major congenital abnormality
• Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
• Participation in another trial that may influence the primary outcome, without prior approval
• Participation in this trial in a prior pregnancy
• Higher order pregnancy

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Glucose samples will be drawn

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Buschur, MD

  tOSU Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Buschur, MD

CONTACT

614-293-8045; Elizabeth.Buschur@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)