NCT07336329Toboroz
Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 150 (tervezett)
- Első benyújtás
- 2026. jan. 10.
- Kezdés
- 2026. jan. 2.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- Kangbuk Samsung Hospital
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07336329
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 150
- 2026. jan. 2. és az elsődleges befejezés (2026. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- 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
- 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
- Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application
Más betegség
- Type 1 diabetes mellitus
- Gestational diabetes mellitus
- History of pancreatectomy
- History of malignancy within 1 year prior to informed consent (except thyroid cancer)
- 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)
Laborértékek
- On hemodialysis or peritoneal dialysis or eGFR < 30 mL/min/1.73m2
- Judged by investigator as unable to handle continuous glucose monitoring device
Egyéb
- Pregnant or lactating women
- Planning pregnancy within 1 year
- Otherwise judged by investigator as inappropriate for participation in this clinical trial
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 19 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | Dél-Korea | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.