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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~0, 30, 60, 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 30, 60, 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucose
Change in glucose variability as measured by continuous glucose monitor
Change in time in range as measured by continuous glucose monitor
Secondary outcome measures
Change in Blood pressure from automated cuff
Change in Body mass index from height and weight
Body Weight Changes
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: UnblindedExperimental Treatment1 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.
Group II: BlindedActive Control1 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.
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
317 Previous Clinical Trials
340,201 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,794 Total Patients Enrolled
Ian J. Neeland, MDLead Sponsor
1 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

Type 2 Diabetes Research Study Groups: Unblinded, Blinded
Type 2 Diabetes Clinical Trial 2023: Dexcom continuous glucose monitor Highlights & Side Effects. Trial Name: NCT05523362 — N/A
Dexcom continuous glucose monitor 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523362 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this experiment?

"This trial is searching for 50 individuals who have been diagnosed with type 2 diabetes mellitus and lie between the ages of 18-99."

Answered by AI

What is the intended result of this research?

"According to DexCom, Inc., the primary metric of this study will be Change in Glucose Variability as monitored by a Continuous Glucose Monitor. Meanwhile, International Physical Activity Questionnaires (IPAQ), Hemoglobin A1c levels from blood samples and patient responses to the Glucose Monitoring Satisfaction Survey are also being assessed over 0-90 day intervals."

Answered by AI

Are there remaining opportunities to join this research trial?

"Per the clinicaltrials.gov database, this medical trial is not actively looking for participants. The first posting was on December 1st 2022 and it has since been updated to October 19th of the same year. Even though registration is currently closed, there are still 1440 other trials recruiting patients at present."

Answered by AI

Could people younger than 70 years old partake in this clinical experiment?

"This research is recruiting participants aged 18 years or over, but no older than 99."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes
Ian J. Neeland, MD 2022. "Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523362.
~17 spots leftby Apr 2025
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