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Continuous Glucose Monitoring for Type 2 Diabetes
N/A
Waitlist Available
Led By Ian Neeland, MD
Research Sponsored by University Hospitals Cleveland Medical Center
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 0, 30, 60, 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a continuous glucose monitoring device is helpful for people with type 2 diabetes who are not taking insulin.
Who is the study for?
This trial is for adults with type 2 diabetes who have an Hb A1c level of at least 7%, a BMI of 30 or higher, and can use a smartphone. They should be able to wear the Dexcom G6 glucose monitor without skin issues but not be on insulin or weight loss meds recently.
What is being tested?
The study tests how well the Dexcom G6 continuous glucose monitoring device works for people with type 2 diabetes who aren't using insulin. It aims to see if this tech helps in managing their condition effectively.
What are the potential side effects?
Wearing the CGM may cause potential skin irritation where it attaches to the body. There are no significant side effects expected from using the Dexcom G6 as it's non-invasive monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 30, 60, 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 30, 60, 90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
Change in Glucose Variability as Measured by Continuous Glucose Monitor
Change in Time in Range as Measured by Continuous Glucose Monitor
Secondary study objectives
Change in Body Mass Index From Height and Weight
Change in Diastolic Blood Pressure From Automated Cuff
Change in Hemoglobin A1c From Blood Test
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blinded followed by UnblindedExperimental Treatment1 Intervention
During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexcom continuous glucose monitor
2022
N/A
~160
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
320 Previous Clinical Trials
339,933 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
144 Previous Clinical Trials
35,429 Total Patients Enrolled
Ian J. Neeland, MDLead Sponsor
1 Previous Clinical Trials
220 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Blinded followed by Unblinded
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.
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