Continuous Glucose MonitoringNCT07298850
A Study on the Effect of CGM Alone on Glycemic Metrics in Type 2 Diabetes Patients Not Using Insulin, Without Additional Interventions
A study testing Continuous glucose monitoring in people with Continuous Glucose Monitoring and Type 2 Diabetes, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Continuous Glucose Monitoring, Type 2 Diabetes
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Continuous Glucose Monitoring, Type 2 Diabetes
- Being tested
- Continuous glucose monitoring
- Keywords
- Type 2 diabetes, Continuous glucose monitoring, Non-insulin Treated Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Percentage of time glucose readings are within the tight target range of 70-140 mg/dL.
Measured: Week 1 and Week 2
Change in Percentage of Time Below Range (TBR) <70 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are below 70 mg/dL, indicating hypoglycemia.
Measured: Week 1 and Week 2
Change in Percentage of Time Below Range (TBR) <54 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are below 54 mg/dL, indicating clinically significant hypoglycemia.
Measured: Week 1 and Week 2
Change in Percentage of Time Above Range (TAR) >140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are above 140 mg/dL. This metric assesses exposure to hyperglycemia, including mild elevations.
Measured: Week 1 and Week 2
Change in Percentage of Time Above Range (TAR) >180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are above 180 mg/dL, indicating hyperglycemia.
Measured: Week 1 and Week 2
Change in Percentage of Time Above Range (TAR) >250 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are above 250 mg/dL, indicating severe hyperglycemia.
Measured: Week 1 and Week 2
Change in Mean Glucose Concentration From Week 1 (Blinded) to Week 2 (Unblinded)
Average glucose concentration (mg/dL) measured by the CGM device.
Measured: Week 1 and Week 2
Change in Glucose Standard Deviation (SD) From Week 1 (Blinded) to Week 2 (Unblinded)
Standard Deviation (SD) of glucose readings, measuring glycemic variability.
Measured: Week 1 and Week 2
Change in Glucose Coefficient of Variation (CV) From Week 1 (Blinded) to Week 2 (Unblinded)
Coefficient of Variation (CV) calculated as (SD / Mean Glucose) * 100, measuring glycemic variability.
Measured: Week 1 and Week 2
Change in Glucose Management Indicator (GMI) From Week 1 (Blinded) to Week 2 (Unblinded)
GMI is an estimated HbA1c level calculated from the mean glucose concentration derived from CGM data.
Measured: Week 1 and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start30 Sep 2024
- Primary completion30 Jul 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- i-SENS, Inc.
- Responsible party
- Principal investigator, Sun Joon, Moon, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298850
- Sponsor's protocol ID
- KBSMC 2024-06-042
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of CGM Alone on Glycemic Metrics in Type 2 Diabetes Patients Not Using Insulin, Without Additional Interventions
- ClinicalTrials.gov ID
- NCT07298850
- Acronym / sponsor ID
- KBSMC 2024-06-042
- Conditions
- Continuous Glucose Monitoring, Type 2 Diabetes
- Keywords
- Type 2 diabetes, Continuous glucose monitoring, Non-insulin Treated Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Collaborators
- i-SENS, Inc.
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sequential CGM Application (Blinded followed by Unblinded) | Experimental | Device: Continuous glucose monitoringSingle 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringAll 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. | Device | Experimental: Sequential CGM Application (Blinded followed by Unblinded) |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
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
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
Change in Mean Glucose Concentration From Week 1 (Blinded) to Week 2 (Unblinded)
Time frame: Week 1 and Week 2
Change in Glucose Standard Deviation (SD) From Week 1 (Blinded) to Week 2 (Unblinded)
Time frame: Week 1 and Week 2
Change in Glucose Coefficient of Variation (CV) From Week 1 (Blinded) to Week 2 (Unblinded)
Time frame: Week 1 and Week 2
Change in Glucose Management Indicator (GMI) From Week 1 (Blinded) to Week 2 (Unblinded)
Time frame: Week 1 and Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring in people with Continuous Glucose Monitoring and Type 2 Diabetes, run by Kangbuk Samsung Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.