Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

NCT07336329 | Recruiting FDA Device

• 1 other identifier: KBSMC 2025-07-031
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test whether wearing a continuous glucose monitor (CGM) part-time works as well as wearing it full-time in adults with type 2 diabetes who do not use insulin. The main questions it aims to answer are:

• Does wearing CGM part-time (2 weeks per month) control blood sugar as well as wearing it continuously?
• How do the two wearing patterns compare for blood sugar levels throughout the day, weight, blood pressure, and patient satisfaction? Researchers will compare part-time CGM use to continuous CGM use to see if part-time use is just as effective for blood sugar control. All participants will:
• Wear a CGM device continuously for 3 months to learn how their blood sugar responds to different foods and activities
• Then be randomly assigned to wear CGM either part-time (2 weeks each month) or continuously for another 3 months
• Replace the CGM sensor on their arm every 2 weeks
• Use a smartphone app to track their blood sugar readings
• Visit the clinic 3 times for blood tests and check-ups
• Receive education on adjusting diet based on their CGM readings
• Keep their current diabetes medications unchanged during the study The study will last about 6 months total. Participants will use the FreeStyle Libre 2 CGM device, which is already approved for use in people with diabetes.

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from 3 to 6 months

  Non-inferiority comparison of the adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 (V2, randomization visit) to month 6 (V3, end of study). The non-inferiority margin is set at 0.3%. The periodic use group will be considered non-inferior to the continuous use group if the lower bound of the 97.5% one-sided confidence interval for the difference in HbA1c change (periodic minus continuous) is greater than -0.3%.

  At 6 months (V3)

Secondary Outcomes (20)

• Change in HbA1c

  At 6 months (V3)

• Change in Blood Pressure

  At 6 months (V3)

• At 6 months (V3)

  At 6 months (V3)

• Change in Body Weight

  At 6 months (V3)

• Change in HOMA-IR

  At 6 months (V3)

Study Arms (2)

Periodic CGM Use

EXPERIMENTAL

All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm wear CGM intermittently for 2 weeks at weeks 2, 6, and 10 (±3 days each). Each sensor is worn for 14 days then removed. During non-wearing periods, no CGM is used. Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.

Device: FreeStyle Libre 2 Continuous Glucose Monitoring

Continuous CGM Use

ACTIVE COMPARATOR

All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm continue to wear CGM continuously for 12 weeks with sensor replacement every 14 days (total 6 replacements). Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.

Device: FreeStyle Libre 2 Continuous Glucose Monitoring

Interventions

FreeStyle Libre 2 Continuous Glucose Monitoring DEVICE

FreeStyle Libre 2 continuous glucose monitoring system consisting of a sensor worn on the upper arm that measures interstitial glucose levels continuously for up to 14 days. Data is transmitted to a smartphone app (FreeStyle LibreLink). The sensor is a Class 3 medical device approved by MFDS (Korea). Participants receive education on adjusting diet based on postprandial glucose patterns observed through CGM. Existing diabetes medications (oral agents and/or GLP-1 agonists) are maintained without changes throughout the intervention period.

Continuous CGM Use; Periodic CGM Use

Eligibility Criteria

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

You may qualify if:

• Adults aged 19 to 80 years at the time of informed consent
• Adults with type 2 diabetes not using insulin
• Patients treated with GLP-1 agonist, oral hypoglycemic agents, and/or lifestyle modifications
• Patients who have maintained stable diabetes treatment for at least 3 months without changes
• HbA1c between 7.5% and 10.0%
• Willing to wear personal continuous glucose monitoring device (CGM)
• Willing to install and use CGM-linked app on personal smartphone with continuous access to WIFI or cellular data
• Able to read and write Korean as judged by investigator
• Willing to use medically acceptable contraception until end of study (sterile status, intrauterine device, or concurrent use of male/female barrier method with spermicide)
• Fully informed about the clinical trial and voluntarily consenting to participate

You may not qualify if:

• Type 1 diabetes mellitus
• Gestational diabetes mellitus
• History of pancreatectomy
• Continuous or intermittent insulin therapy for 7 days or more within 3 months
• Oral or IV steroid treatment within 1 month prior to informed consent
• Serious infection, surgery (scheduled or history), or severe trauma within 3 months prior to informed consent
• History of malignancy within 1 year prior to informed consent (except thyroid cancer)
• On hemodialysis or peritoneal dialysis or eGFR \< 30 mL/min/1.73m2
• Unable to avoid the following concomitant medications, devices, or treatments during the study: CGM other than study device, X-ray/MRI/CT scans, radiofrequency thermal therapy, implantable devices such as pacemakers, immunosuppressants, steroids, IV vitamin preparations, cancer treatment, hemodialysis/peritoneal dialysis, insulin therapy
• Uncontrolled thyroid disease or clinically significant severe endocrine disorders (Cushing's syndrome, pheochromocytoma, etc.)
• Severe allergic reaction to skin adhesives (e.g., dyspnea, severe rash, edema)
• Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application
• Judged by investigator as unable to handle continuous glucose monitoring device
• Pregnant or lactating women
• Planning pregnancy within 1 year

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea, 03181, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sun-Joon Moon, MD, PhD

CONTACT

+82-2-2001-1550; ipleat.m@gmail.com

Study Design

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

Model Details: This is a non-inferiority trial comparing periodic versus continuous use of CGM

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 13, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual participant data will be available beginning December 2028, approximately 24 months after the primary completion date. Data will be available for 5 years following initial availability. Supporting documents (protocol, SAP, CSR) will be made available at the same time.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for secondary analysis. Access will be granted at the discretion of the study investigators based on the scientific merit and feasibility of the proposed research.

Locations

KR (1)