real time continuous glucose monitor for Gestational Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gestational Diabetesreal time continuous glucose monitor - Device
Eligibility
18 - 45
Female
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Study Summary

This trial will test whether using a continuous glucose monitoring system (CGMS) can help improve glycemic control and reduce risks of adverse pregnancy outcomes in gestational diabetes mellitus (GDM) patients, compared to traditional self-monitored blood glucose (SMBG) use.

Eligible Conditions
  • Gestational Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: at time of delivery

at time of delivery
Large-for -gestational age newborns
Neonatal hypoglycemia
immediately after delivery
CGM-satisfaction (CGM SAT) survey
Perceived benefit questionnaire (GMS)
Week 38
HbA1c
percent weight gain during pregnancy
up to 32 weeks
Average percent time in glucose range
time spent in hyperglycemia (time above range)
time spent in hypoglycemia (time below range)

Trial Safety

Trial Design

2 Treatment Groups

SMBG with blinded CGM
1 of 2
Real-time (rt) CGMS with SMBG
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: real time continuous glucose monitor · No Placebo Group · N/A

Real-time (rt) CGMS with SMBG
Device
Experimental Group · 1 Intervention: real time continuous glucose monitor · Intervention Types: Device
SMBG with blinded CGM
Device
ActiveComparator Group · 1 Intervention: blinded continuous glucose monitor · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at time of delivery

Who is running the clinical trial?

Woman'sLead Sponsor
16 Previous Clinical Trials
1,282 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
125 Previous Clinical Trials
13,472 Total Patients Enrolled
Karen Elkind-Hirsch, PhDPrincipal InvestigatorWoman's Hospital, Louisiana
2 Previous Clinical Trials
159 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · Female Participants · 4 Total Inclusion Criteria

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