Full-time versus part-time continuous glucose monitoring for adults with type 2 diabetes who do not use insulin.
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
This study will see if wearing a continuous glucose monitor part-time (two weeks each month) controls blood sugar as well as wearing it all the time in adults with type 2 diabetes who do not take insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Kangbuk Samsung Hospital Academic / other |
| Locations | 1 site (Seoul, South Korea) |
| Trial ID | NCT07336329 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19–80 with type 2 diabetes who are not on insulin, have an HbA1c of 7.5–10.0%, have had stable diabetes treatment for at least three months, are willing to wear a CGM and use a smartphone app, and can read and write Korean.
Not a fit: People who use insulin, have type 1 or gestational diabetes, prior pancreatectomy, inability to use a smartphone or the app, or who cannot attend visits in Seoul are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If part-time CGM provides similar glucose control, patients could get comparable benefits with lower device burden and cost.
How similar studies have performed: Previous studies of CGM in non-insulin-treated type 2 diabetes have shown improvements in glucose measures and engagement, but direct comparisons of continuous versus scheduled part-time CGM are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul, South Korea
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.