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CGMS vs. SMBG for Gestational Diabetes (STEADYSUGAR Trial)
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Waitlist Available
Led By Karen Elkind-Hirsch, PhD
Research Sponsored by Woman's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of delivery
Awards & highlights
STEADYSUGAR Trial 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.
Who is the study for?
This trial is for pregnant women between 8-26 weeks with gestational diabetes confirmed by a glucose tolerance test, carrying one baby. It's not for those with severe psychiatric disorders, prior diabetes, multiple pregnancies, or on long-term steroids.Check my eligibility
What is being tested?
The study compares two methods of monitoring blood sugar levels in pregnant women with gestational diabetes: real-time continuous glucose monitoring (CGMS) and traditional self-monitoring (SMBG). The goal is to see if CGMS leads to better control of blood sugar and healthier pregnancy outcomes.See study design
What are the potential side effects?
While the trial itself does not involve medication that would cause side effects, using CGMS may lead to skin irritation where the device attaches or discomfort from wearing the device continuously.
STEADYSUGAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average percent time in glucose range
Secondary outcome measures
HbA1c
Large-for -gestational age newborns
Neonatal hypoglycemia
+3 moreOther outcome measures
CGM-satisfaction (CGM SAT) survey
Perceived benefit questionnaire (GMS)
STEADYSUGAR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Real-time (rt) CGMS with SMBGExperimental Treatment1 Intervention
Real time continuous glucose monitoring plus self-monitored blood glucose
Group II: SMBG with blinded CGMActive Control1 Intervention
Self monitored blood glucose with blinded continuous glucose monitoring
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Who is running the clinical trial?
Woman'sLead Sponsor
17 Previous Clinical Trials
1,326 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,722 Total Patients Enrolled
Karen Elkind-Hirsch, PhDPrincipal InvestigatorWoman's Hospital, Louisiana
3 Previous Clinical Trials
230 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a positive test for how your body handles sugar after drinking a sugary solution.I have been diagnosed with diabetes.I do not have severe illnesses besides my cancer.I am already taking medication to lower my blood sugar.I am unable or unwilling to follow the study's requirements.I have not had severe depression or psychiatric disorders requiring hospitalization in the past year.I have had surgery in the past that affects how my body absorbs food.I currently have an infection.You are in the 8th to 26th week of pregnancy.I have been using steroids for more than 2 weeks.You are pregnant with only one baby.You are pregnant with more than one baby.My baby is not growing as expected because of placenta issues.
Research Study Groups:
This trial has the following groups:- Group 1: Real-time (rt) CGMS with SMBG
- Group 2: SMBG with blinded CGM
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 individuals have been selected to participate in this experiment?
"Yes, the information on clinicaltrials.gov affirms that this experiment is actively recruiting participants. This clinical trial was initially published on October 1st 2021 and has since been revised as of October 19th 2021. The study requires 100 volunteers at a single medical centre."
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Is the age range for this clinical trial expansive enough to accommodate individuals older than 40?
"This clinical trial is seeking participants aged 18 or over, and 45 years of age or younger."
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Are there any vacancies remaining for participation in this medical trial?
"That is correct. Clinicaltrials.gov attests to this clinical trial's ongoing recruitment process, which was initiated on October 1st 2021 and modified most recently on the 19th of that month. The study requires 100 volunteers from a single site for its completion."
Answered by AI
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