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

NCT07298850 | Active Not Recruiting DMC

• 1 other identifier: KBSMC 2024-06-042
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Continuous Glucose Monitoring

Keywords

Type 2 diabetes; Continuous glucose monitoring; Non-insulin Treated Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Time in Range (TIR) 70-180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

  Percentage of time glucose readings are within the target range of 70-180 mg/dL.

  Week 1 and Week 2

Secondary Outcomes (10)

• Change in Percentage of Time in Tight Range (TITR) 70-140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

  Week 1 and Week 2

• Change in Percentage of Time Below Range (TBR) <70 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

  Week 1 and Week 2

• Change in Percentage of Time Below Range (TBR) <54 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

  Week 1 and Week 2

• Change in Percentage of Time Above Range (TAR) >140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

  Week 1 and Week 2

• Change in Percentage of Time Above Range (TAR) >180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

  Week 1 and Week 2

Study Arms (1)

Experimental: Sequential CGM Application (Blinded followed by Unblinded)

EXPERIMENTAL

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.

Device: Continuous glucose monitoring

Interventions

Continuous glucose monitoring DEVICE

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.

Experimental: Sequential CGM Application (Blinded followed by Unblinded)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists
• Ages 19 - 80 years old
• Patients who have voluntarily signed the informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• i-SENS, Inc.: collaborator

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, Jongro-Ku, 03181, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 23, 2025
• Study Start: September 30, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 1, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)