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Diagnostic Test
Continuous Glucose Monitoring for Gestational Diabetes
N/A
Recruiting
Led By Amy Valent
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-55 years
Singleton pregnancy ≥20 weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to10 days after discharge from hospital following delivery
Awards & highlights
Study Summary
This trial suggests that the continual glucose method may help women with gestational diabetes to better control their blood sugar levels.
Who is the study for?
This trial is for pregnant women aged 18-55 with gestational diabetes, at least 20 weeks into a single pregnancy. They must be diagnosed with GDM and have a compatible phone or option to use a receiver for the CGM app. Women using other investigational drugs, with chronic immunosuppression, allergies to adhesives, multiple pregnancies, substance abuse issues or severe mental illnesses are excluded.Check my eligibility
What is being tested?
The study is testing if continuous glucose monitoring (CGM) can better maintain blood sugar levels within target ranges compared to standard self-capillary blood glucose monitoring (SCBG) in women with gestational diabetes.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the adhesive used in CGM devices and possible inaccuracies leading to mismanagement of glucose levels. However, specific side effects will depend on individual reactions to wearing the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Select...
I am over 20 weeks pregnant with one baby.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to10 days after discharge from hospital following delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to10 days after discharge from hospital following delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average time-in-range over a 24 hour period
Secondary outcome measures
Average time-in-range during waking hours
Average time-in-range while asleep
Trial Design
2Treatment groups
Experimental Treatment
Group I: Referent ArmExperimental Treatment1 Intervention
Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks.
Group II: Intervention ArmExperimental Treatment1 Intervention
Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous glucose monitoring (CGM)
2016
Completed Phase 4
~120
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
978 Previous Clinical Trials
7,386,394 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
138 Previous Clinical Trials
29,726 Total Patients Enrolled
Amy ValentPrincipal InvestigatorOregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have diabetes before getting pregnant.You have been diagnosed with gestational diabetes using specific tests.You have an allergy to medical adhesives.I do not have severe mental illness or eating disorders that could affect my safety or participation.You are currently using alcohol or illegal drugs.I am between 18 and 55 years old.I am on long-term medication to suppress my immune system.You are pregnant with more than one baby.I am over 20 weeks pregnant with one baby.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Referent Arm
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.
What is the aggregate participation in this research endeavor?
"Affirmative. Clinicaltrials.gov verifies that this research is actively searching for participants, having been initially posted on February 11th 2021 and most recently updated on April 27 2022. 110 individuals must be recruited at a solitary clinical site to meet the study's requirements."
Answered by AI
Are there vacancies in this clinical trial for prospective participants?
"According to the clinicaltrials.gov registry, this trial is currently in search of suitable participants. It was initially uploaded on February 11th 2021 and recently updated on April 27th 2022."
Answered by AI
Does the trial include participants aged 30 and above?
"As stated in the trial's inclusion requirements, participants must be from 18 to 55 years old."
Answered by AI
Are there any criteria that disqualify me from participating in this research?
"To qualify for this medical trial, applicants should have diabetes mellitus and fall within the age range of 18 to 55. A total of 110 participants are being sought out."
Answered by AI
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