💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
HealthTeky