A Study on the Effect of CGM Alone on Glycemic Metrics in Type 2 Diabetes Patients Not Using Insulin, Without Additional Interventions
NCT ID: NCT07298850
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2024-09-30
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Sequential CGM Application (Blinded followed by Unblinded)
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.
Continuous glucose monitoring
All participants are adults with non-insulin-treated type 2 diabetes. Participants will wear a real-time continuous glucose monitoring (rt-CGM) device (CareSens Air) for a total of two weeks. The intervention consists of two consecutive phases:
1. Week 1 (Blinded Mode): Participants wear the CGM but cannot view their glucose readings. This period establishes baseline glycemic data.
2. Week 2 (Unblinded Mode): The same CGM session continues, but the mode is switched to "unblinded." Participants can view their real-time glucose levels and trend arrows.
Throughout the study, no additional structured education (e.g., diet or exercise coaching) or medication adjustments by the investigators are provided. The study evaluates the effect of data visibility alone on glycemic metrics.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Continuous glucose monitoring
All participants are adults with non-insulin-treated type 2 diabetes. Participants will wear a real-time continuous glucose monitoring (rt-CGM) device (CareSens Air) for a total of two weeks. The intervention consists of two consecutive phases:
1. Week 1 (Blinded Mode): Participants wear the CGM but cannot view their glucose readings. This period establishes baseline glycemic data.
2. Week 2 (Unblinded Mode): The same CGM session continues, but the mode is switched to "unblinded." Participants can view their real-time glucose levels and trend arrows.
Throughout the study, no additional structured education (e.g., diet or exercise coaching) or medication adjustments by the investigators are provided. The study evaluates the effect of data visibility alone on glycemic metrics.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
19 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
i-SENS, Inc.
INDUSTRY
Kangbuk Samsung Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sun Joon, Moon
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kangbuk Samsung Hospital
Seoul, Jongro-Ku, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KBSMC 2024-06-042
Identifier Type: -
Identifier Source: org_study_id