Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Continuous Glucose Monitors in the Care of Pregnant and Postpartum Women to Limit Frequency of Staff Exposure and Preserve Staff Personal Protective Equipment

Conditions
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Diabetes Mellitus (DM)

Intervention / Treatment
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* Device: Dexcom G6


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dexcom CGM<br>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 | Device: Dexcom G6<br>* Continuous glucose monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal outcomes | Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c | 1 year | 
| Neonatal outcomes | Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate | 1 year | 
| Maternal outcomes | Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels | 1 year |