Diabetes Mellitus (DM)
Conditions
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.
Interventions
DEVICEDexcom G6
Continuous glucose monitor
Sponsors
DexCom, Inc.
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal outcomes | 1 year | Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c |
| Neonatal outcomes | 1 year | Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate |
Countries
United States
Contacts
Primary ContactElizabeth Buschur, MD
Outcome results
None listed