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Continuous Glucose Monitoring System
Continuous Glucose Monitoring for Type 2 Diabetes
N/A
Waitlist Available
Led By Colette Knight, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months post enrollment
Awards & highlights
Study Summary
This trial will test if using a continuous glucose monitor can help people with type 2 diabetes, particularly those from racial/ethnic minority backgrounds, better manage their condition.
Who is the study for?
This trial is for African American or Hispanic adults with type 2 diabetes, aged 18 and older, who have an A1c level between 8% to 12%. It's not suitable for those on steroids, with adhesive allergies, past CGM users within a year, type 1 diabetes patients, pregnant individuals or people with end-stage renal disease.Check my eligibility
What is being tested?
The study tests if using a continuous glucose monitoring system along with education support can help manage diabetes better in people from health disparity backgrounds. Participants will be monitored over six months to see the effects on their glucose control.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the monitor's adhesive and possible discomfort during sensor insertion. The educational component does not have physical side effects but requires time commitment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months post enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months post enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A1c - Marker of overall glucose control
Glycemic control
Secondary outcome measures
BMI
Blood pressure
Diabetes distress
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Continuous Glucose Monitoring and Education Support GroupExperimental Treatment1 Intervention
Participants will be provided with a device to monitor their blood glucose (Abbott Free Style Libre2 Flash CGM system) along with educational materials to better understand and manage their diabetes and other supporting services. Pre and post intervention surveys will be implemented. Participants will be closely monitored for 3 months and then followed up for 3 more months for a total of 6-month participation.
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Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,210 Total Patients Enrolled
Colette Knight, MDPrincipal InvestigatorHackensack Meridian Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Adults who are 18 years or older with type 2 diabetes.You have type 1 diabetes.You have a very advanced kidney disease.If you are African-American or Hispanic, your A1c (a measure of blood sugar) should be between 8% and 12%.You are currently taking steroids or have had an allergic reaction to adhesive materials in the past.You have used a continuous glucose monitor (CGM) in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Glucose Monitoring and Education Support Group
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.
Is this study presently open to new participants?
"The clinical trial is currently searching for suitable participants. It was initially posted on May 15th, 2023 and modified two days later on the 17th of that same month."
Answered by AI
How many volunteers are participating in this clinical exploration?
"Affirmative. The information on clinicaltrials.gov connotes that this scientific trial is presently seeking out participants. This research endeavor was first posted on May 15th, 2023 and most recently amended 5 days later. The study requires 34 patients to be recruited from a single site."
Answered by AI
What is the intent of this research endeavor?
"This medical trial aims to observe the impact of a combination of continuous glucose monitoring and diabetes education on glycemic control over 6 months. Secondary measurements include BMI, hospital admissions due to extreme hyper- or hypoglycemia, as well as episodes of hypoglycemia in that same period."
Answered by AI
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