Full-time versus part-time continuous glucose monitoring for adults with type 2 diabetes who do not use insulin.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with type 2 diabetes not using insulin first wear a FreeStyle Libre 2 continuous glucose monitor continuously for three months to learn their glucose patterns. After that run-in, participants are randomly assigned to either continue wearing the CGM continuously or to wear it part-time (two weeks each month) for an additional three months, with sensors replaced every two weeks. Participants use a smartphone app to capture glucose data and attend clinic visits at Kangbuk Samsung Hospital for monitoring. The study compares glucose control (including HbA1c and time-in-range), daily glucose patterns, weight, blood pressure, and patient satisfaction between the two wearing strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Otherwise judged by investigator as inappropriate for participation in this clinical trial

Where it's running

• Kangbuk Samsung Hospital
  Seoul, South Korea, South Korea Recruiting

Study contacts

• Study coordinator: Sun-Joon Moon, MD, PhD
• Email: ipleat.m@gmail.com
• Phone: +82-2-2001-1550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.