Type 2 Diabetes (T2D) Clinical Trials

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Effectiveness of Periodic Use of Continuous Glucose Monitoring After Three Months of Continuous Use in Patients With Non-Insulin-Treated Type 2 Diabetes Patients: A Multicenter, Randomized, Parallel-Group, Open-Label, Non-Inferiority, Investigator-Initiated Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Kangbuk Samsung Hospital
RECRUITING
Seoul
Contact Information
Primary
Sun-Joon Moon, MD, PhD
ipleat.m@gmail.com
+82-2-2001-1550
Time Frame
Start Date: 2026-01-02
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 150
Treatments
Experimental: Periodic CGM Use
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.
Active_comparator: Continuous CGM Use
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.
Related Therapeutic Areas
Sponsors
Leads: Kangbuk Samsung Hospital

This content was sourced from clinicaltrials.gov