Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07298850

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Continuous Glucose Monitoring Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, Jongro-Ku, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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:

  • Week 1 (Blinded Mode): Participants wear the CGM but cannot view their glucose readings. This period establishes baseline glycemic data.
  • 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.

Primary outcomes

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

    Time frame: Week 1 and Week 2

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

Secondary outcomes

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

    Time frame: Week 1 and Week 2

    Percentage of time glucose readings are within the tight target range of 70-140 mg/dL.

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

    Time frame: Week 1 and Week 2

    Percentage of time glucose readings are below 70 mg/dL, indicating hypoglycemia.

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

    Time frame: Week 1 and Week 2

    Percentage of time glucose readings are below 54 mg/dL, indicating clinically significant hypoglycemia.

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

    Time frame: Week 1 and Week 2

    Percentage of time glucose readings are above 140 mg/dL. This metric assesses exposure to hyperglycemia, including mild elevations.

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

    Time frame: Week 1 and Week 2

    Percentage of time glucose readings are above 180 mg/dL, indicating hyperglycemia.

  6. Change in Percentage of Time Above Range (TAR) >250 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)

    Time frame: Week 1 and Week 2

    Percentage of time glucose readings are above 250 mg/dL, indicating severe hyperglycemia.

  7. Change in Mean Glucose Concentration From Week 1 (Blinded) to Week 2 (Unblinded)

    Time frame: Week 1 and Week 2

    Average glucose concentration (mg/dL) measured by the CGM device.

  8. Change in Glucose Standard Deviation (SD) From Week 1 (Blinded) to Week 2 (Unblinded)

    Time frame: Week 1 and Week 2

    Standard Deviation (SD) of glucose readings, measuring glycemic variability.

  9. Change in Glucose Coefficient of Variation (CV) From Week 1 (Blinded) to Week 2 (Unblinded)

    Time frame: Week 1 and Week 2

    Coefficient of Variation (CV) calculated as (SD / Mean Glucose) * 100, measuring glycemic variability.

  10. Change in Glucose Management Indicator (GMI) From Week 1 (Blinded) to Week 2 (Unblinded)

    Time frame: Week 1 and Week 2

    GMI is an estimated HbA1c level calculated from the mean glucose concentration derived from CGM data.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

  • i-SENS, Inc.

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.