Continuous Glucose Monitoring for Women With Diabetes Mellitus in the Intrapartum and Postpartum Inpatient Care

NCT05492890 | Unknown FDA Device

• 1 other identifier: 2020H0498
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Maternal outcome

  Assessed by analyzing the number of hypoglycemic and hyperglycemic episodes prior to and post-delivery as determined by glucose measurements

  9 months

Secondary Outcomes (1)

• Neonatal outcomes

  10 days

Study Arms (2)

Dexcom CGM

Continuous glucose monitoring

Device: Dexcom G6

Point of care testing

Finger poke glucose measure

Interventions

Dexcom G6 DEVICE

Continuous glucose monitoring

Dexcom CGM

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant woman
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women ages 18-45 who are pregnant

You may qualify if:

• Age 18-50 years
• Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
• Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
• 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:

• Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
• 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
• History of severe skin allergy to adhesive products or CGM within the previous 3 months

Sponsors & Collaborators

• Ohio State University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Point of care blood glucose samples will be collected

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: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share