Your session is about to expire
← Back to Search
Continuous Glucose Monitoring for Gestational Diabetes
N/A
Recruiting
Led By Nicole M Ehrhardt, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
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.
Who is the study for?
This trial is for pregnant individuals diagnosed with gestational diabetes before the 28th week of pregnancy, who can read English and have at least a 6th-grade education level. They must be able to understand and sign consent forms. Those with established fetal anomalies, risk of early delivery due to conditions other than gestational diabetes, or pre-existing Type 1 or Type 2 diabetes are not eligible.Check my eligibility
What is being tested?
The study is testing if using a Real-Time Continuous Glucose Monitor (RT-CGM) can help control blood sugar levels better in patients with gestational diabetes compared to standard monitoring methods. It also looks at whether this technology improves health outcomes for both the mother and baby.See study design
What are the potential side effects?
While RT-CGM devices are generally considered safe, potential side effects may include skin irritation where the sensor is placed, inaccurate readings leading to mismanagement of glucose levels, and possible discomfort or anxiety from continuous monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health of baby using delivery and post delivery well baby assessments
Health of mother using CGM to monitor blood glucose during pregnancy
Side effects data
From 2009 Phase 3 trial • 451 Patients • NCT0040613311%
Severe Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secondary Cohort Control Group
Primary Cohort RT-CGM Group
Primary Cohort Control Group
Secondary Cohort RT-CGM Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blinded Continuous Glucose Monitoring DeviseExperimental Treatment1 Intervention
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous glucose monitor
2006
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,734 Previous Clinical Trials
1,842,505 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
136 Previous Clinical Trials
29,735 Total Patients Enrolled
Nicole M Ehrhardt, MDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with a baby who has known health issues or you might deliver early because of your own health problems other than gestational diabetes.You have been recently diagnosed with diabetes during pregnancy.You are less than 14 weeks pregnant.You have diabetes that started before you became pregnant.You have Cushing's syndrome.You have had weight loss surgery in the past.You are already using continuous glucose monitoring.You have been diagnosed with gestational diabetes.You are pregnant and less than 28 weeks along.You have a long-lasting infection.You are currently taking any steroid pills.You are pregnant with only one baby.
Research Study Groups:
This trial has the following groups:- Group 1: Blinded Continuous Glucose Monitoring Devise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in the current research?
"Affirmative. According to clinicaltrials.gov, this research endeavour is still recruiting patients after being first posted on April 10th 2021 and last updated November 11th of the same year. The trial aims to be completed by a total of 100 participants at one location."
Answered by AI
Are there any vacanies for participants in this medical experiment?
"Data uploaded to clinicaltrials.gov suggests that this research is currently recruiting participants, with the trial first being advertised on April 10th 2021 and recently updated on November 11th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger