Treatment for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University Medical Center, Columbus, OH
Diabetes Mellitus
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Maternal outcomes
Neonatal outcomes

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

40 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: The Ohio State University Medical Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2006First Recorded Clinical Trial
5 TrialsResearching Diabetes Mellitus
127 CompletedClinical Trials

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
692 Previous Clinical Trials
375,550 Total Patients Enrolled
18 Trials studying Diabetes Mellitus
2,196 Patients Enrolled for Diabetes Mellitus
DexCom, Inc.Industry Sponsor
121 Previous Clinical Trials
13,075 Total Patients Enrolled
80 Trials studying Diabetes Mellitus
9,467 Patients Enrolled for Diabetes Mellitus
Elizabeth Buschur, MDPrincipal InvestigatorOhio State University
2 Previous Clinical Trials
112 Total Patients Enrolled
1 Trials studying Diabetes Mellitus
40 Patients Enrolled for Diabetes Mellitus

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a woman 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.
You are able to understand the study and provide written informed consent in English.
Infants who survive to hospital discharge who are born to women enrolled in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.