A Study on the Effect of CGM Alone on Glycemic Metrics in Type 2 Diabetes Patients Not Using Insulin, Without Additional Interventions

Kangbuk Samsung Hospital

Status: Active, not recruiting

Conditions: Continuous Glucose Monitoring; Type 2 Diabetes

Treatments: Device: Continuous glucose monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07298850

KBSMC 2024-06-042

Details and patient eligibility

About

This study evaluates the effect of using a real-time continuous glucose monitoring (CGM) system on blood sugar control in people with type 2 diabetes who do not use insulin.

Participants will wear a CGM device (CareSens Air) for a total of two weeks. During the first week, the device will be set to "blinded mode," meaning participants cannot see their glucose readings. During the second week, the device will be switched to "unblinded mode," allowing participants to view their glucose levels and trends in real-time.

The study aims to determine if simply seeing real-time glucose data can help patients improve their blood sugar control (such as increasing the time their blood sugar is in the target range) without receiving additional structured education on diet or exercise. Researchers will compare the glucose data collected during the blinded week with the data from the unblinded week.

Enrollment: 120 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with Type 2 Diabetes Mellitus (HbA1c ≥ 6.5%, fasting plasma glucose ≥ 126 mg/dL, 2-hour plasma glucose ≥ 200 mg/dL during 75g OGTT, or random plasma glucose ≥ 200 mg/dL with classic symptoms)
2. No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists
3. Ages 19 - 80 years old
4. Patients who have voluntarily signed the informed consent form

Exclusion criteria

1. Type 1 diabetes patients
2. Insulin users
3. Patients who have changed oral hypoglycemic agents within the past 3 months
4. Patients scheduled for hospitalization within 2 weeks
5. Pregnant women or those planning pregnancy within 1 month
6. Those who do not agree to the program
7. Those deemed unsuitable for participation in this clinical trial by the investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Experimental: Sequential CGM Application (Blinded followed by Unblinded)

Experimental group

Description:

Single arm consisting of adults with non-insulin-treated type 2 diabetes. All participants undergo a 2-week prospective observation using a real-time CGM device (CareSens Air), transitioning from a blinded baseline period to an unblinded intervention period to evaluate glycemic changes.

Treatment:

Device: Continuous glucose monitoring