Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT05478070

Conditions

Diabetes Mellitus (DM)

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Dexcom G6

Study Details

Brief summary:

Diabetes mellitus (DM) affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Current obstetric practice is complicated by the emergence of the SARS-COV-2 pandemic, resulting in morbidity and mortality secondary to complications of COVID-19. Care coordination among the teams caring for women admitted for antepartum, intrapartum, and postpartum care with suspected or confirmed COVID-19 is required to conserve PPE and minimize staff exposure. The investigators propose a pilot proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations, as a proof of concept in the efforts to reduce the number of point of care glucose tests needed, reduce staff exposure, and conserve PPE use.

Conditions

Diabetes Mellitus (DM)

Study ID

NCT05478070

Start date

May 15, 2022

Status verified date

Jul, 2022

Completion date

May, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women aged 18-50 years with a viable singleton or twin intrauterine pregnancy between 8 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
  • Diagnosis of pre-gestational or gestational diabetes mellitus A2, admitted to the hospital for labor or other antepartum admissions (besides DKA or glucoregulation)
  • Able to understand the study, and having understood, provide written informed consent in English
  • Infants who survive to hospital discharge who are born to women enrolled in the study

Exclusion Criteria:

  • Participation in another trial that may influence the primary outcome, without prior approval
  • Higher order pregnancy
  • History of severe skin allergy to adhesive products or CGM
  • DKA, admission for glucoregulation
  • COVID-19 PUI or confirmed positive

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Dexcom CGM

Proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations

Interventions

Dexcom G6

Continuous glucose monitor

Primary outcome measure

  • Maternal outcomes [ Time Frame: 1 year ]
  • Neonatal outcomes [ Time Frame: 1 year ]
  • Maternal outcomes [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

More Information

Sponsor

Ohio State University

Last update posted

Jul 28, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2022-07-28.