Completed

Dexcom G6 CGM Device for Non-Insulin Treated Type 2 Diabetes Care

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Study Aim

This study aims to evaluate the changes in average glucose levels, glucose variability, and time spent within the acceptable glucose range in individuals with non-insulin treated type 2 diabetes, using the Dexcom G6 Continuous Glucose Monitor (CGM) device.

What is being tested

Dexcom continuous glucose monitor

Device
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 99 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: January 2022
See protocol details

Summary

Principal SponsorIan J. Neeland, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2022

Actual date on which the first participant was enrolled.

This study focuses on the Dexcom G6 Continuous Glucose Monitoring system, a device designed to help manage Type 2 Diabetes in patients who are not using insulin therapy. The main goal is to understand how well this device works in everyday care and how it can benefit patients. The study involves individuals with Type 2 Diabetes, aiming to improve their care and address the challenges associated with managing blood sugar levels without insulin. This research is important as it could lead to better ways to monitor and control blood sugar levels, ultimately improving the quality of life for those with Type 2 Diabetes. During the study, participants wear the Dexcom G6 device, which continuously monitors their blood glucose levels. The study has two phases. In the first phase, lasting 10 days, participants cannot see the data from the device and continue their usual care, including twice-daily glucose checks. In the second phase, lasting three months, both participants and their healthcare providers can see the data. The device's effectiveness is measured by changes in average glucose levels, glucose variability, and the time spent within the acceptable glucose range (between 80-180 mg/dl). Throughout the study, participants receive usual care, including lifestyle education, virtual support, medical visits, medication interventions, and nursing support.

Official TitleFeasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy
NCT05523362
Principal SponsorIan J. Neeland, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Type 2 diabetes of any duration

Hb A1c ≥ 7% (no upper limit)

BMI ≥ 30 kg/m2

Ability to wear CGM (e.g. no dermatological issue precluding device insertion)

Show More Criteria

5 exclusion criteria prevent from participating
Any insulin use in the past 3 months

Planned use of insulin in the next 6 months

Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate

Current use of a weight loss medication

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hospitals Cleveland Medical Center

Cleveland, United StatesOpen University Hospitals Cleveland Medical Center in Google Maps
CompletedOne Study Center