Continuous glucose monitor for Diabetes, Gestational

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetes, Gestational+2 More
Continuous glucose monitor - Device
Eligibility
Any Age
Female
What conditions do you have?
Select

Study Summary

This trial will help researchers understand if real-time continuous glucose monitoring (RT-CGM) can improve blood sugar control, pregnancy outcomes, and fetal outcomes in patients with gestational diabetes.

Eligible Conditions
  • Diabetes, Gestational
  • Gestational Diabetes Mellitus (GDM)

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 4 years

4 years
Health of baby using delivery and post delivery well baby assessments
Health of mother using CGM to monitor blood glucose during pregnancy

Trial Safety

Side Effects for

Secondary Cohort Control Group
11%Severe Hypoglycemia
This histogram enumerates side effects from a completed 2009 Phase 3 trial (NCT00406133) in the Secondary Cohort Control Group ARM group. Side effects include: Severe Hypoglycemia with 11%.

Trial Design

1 Treatment Group

Blinded Continuous Glucose Monitoring Devise
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Continuous glucose monitor · No Placebo Group · N/A

Blinded Continuous Glucose Monitoring Devise
Device
Experimental Group · 1 Intervention: Continuous glucose monitor · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous glucose monitor
2006
Completed Phase 3
~640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,585 Previous Clinical Trials
1,565,983 Total Patients Enrolled
1 Trials studying Diabetes, Gestational
360 Patients Enrolled for Diabetes, Gestational
DexCom, Inc.Industry Sponsor
122 Previous Clinical Trials
13,054 Total Patients Enrolled
5 Trials studying Diabetes, Gestational
901 Patients Enrolled for Diabetes, Gestational
Nicole M Ehrhardt, MDPrincipal InvestigatorUniversity of Washington

Eligibility Criteria

Age Any Age · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have been diagnosed with gestational diabetes, you will need to follow a specific diet and exercise plan to keep your blood sugar levels under control.
Can read and write in English and has completed the sixth grade.
and restrictions I can read, understand, and sign the Informed Consent Form (ICF), and if applicable, an Authorization to Use and Disclose Protected Health Information form
A pregnancy is said to be viable if it is past 28 weeks gestation
means a pregnancy in which there is only one baby

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: November 25th, 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.