None listed
Conditions
Interventions
Medical Device : (EOPatchM), (MiniMed 640G), Multiple Daily Injections(MDI), 12FU, Crossover (EOPatch) 12FU
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Screening timepoint 1) Adult male and female over the age of 19 and under the age of 70 2) Patients with type 2 diabetes who are not controlled by insulin multidose therapy or multidose mixed insulin 3) Patients with glycated hemoglobin of 7.5% or higher at the screening visit or the most recent test within 3 months of the screening visit 4) Those who have not changed their insulin therapy for more than 3 months (the dose can be changed) 5) Those who use one of the following insulin therapies ? Basal insulin + prandial insulin 2 or more times a day ? Novomix or Humalogmix insulin 2 or more times a day ? Ryzodeg 2 or more times a day ? Ryzodeg once daily + 1 or more additional prandial insulins * Mixed insulin users are limited to those who refuse multiple insulin therapy 6) Those who have not changed the type and dose of oral diabetes medications they have been taking for the past 3 months 7) Those who agreed to use continuous glucose monitoring (CGM) during the clinical trial period 8) Those who have agreed to use a medically acceptable method of contraception* for the duration of the clinical trial and up to 30 days after the end of the clinical trial * Medically accepted methods of contraception: condoms, oral contraceptives lasting for at least 6 weeks, use of injectable or implantable contraceptives, installation of an intrauterine contraceptive device, etc. 9) A person who understands the clinical trial details, is cooperative with the progress, and voluntarily agrees to participate by the end of the clinical trial
Exclusion criteria
Exclusion criteria: [Main study] 1) Those who have been diagnosed with type 1 diabetes, patients with type 2 diabetes other than the study target disease (T2D), and those with gestational diabetes 2) Those who performed Pancreatectomy 3) Those who have used an insulin pump in the last 3 months 4) Those who have used systemic steroids within the last 3 months or are expected to use them during the study period 5) Those on hemodialysis or peritoneal dialysis 6) CKD stage IV or higher (eGFR<30ml/min/1.73m2) 7) Those who have been diagnosed with a malignant tumor within the previous 5 years (except for those who are in a stable state according to the investigator's judgment without progression or metastasis after cancer diagnosis) 8) Those who have newly developed coronary artery disease or cerebrovascular disease such as myocardial infarction or angina within the previous 3 months 9) Those with severe uncontrolled hypertension (systolic blood pressure of 180 mmHg or more or diastolic blood pressure of 110 mmHg or more) 10) Those with AST or ALT greater than 2.5 times the upper limit of the normal range 11) Those who have pregnant and breast feeding or expecting to be pregnant. 12) Those who have problems with the application of investigational devices for clinical trials. (Example: If you are allergic to insulin (Humalog, NovoRapid), If you are allergic to acrylate-based skin adhesives) 13) Those who continuously require MRI and CT scans and diathermy 14) Those diagnosed with alcoholism or drug addiction 15) Those who are judged by the investigator to be difficult to handle insulin pumps and regulators 16) Those who have participated in other clinical trials within the last 3 months 17) Those whose life expectancy is less than 3 months due to malignant tumors or terminal cancer 18) In addition to the above, those who judged that the investigator is inappropriate to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary endpoint variables Changes in the ratio of 70-180 mg/dL TIR between visits 3 and 6 (week 12) compared to 70-180 mg/dL TIR between visits 1 and 3 confirmed by sensor glucose values 1) Test Group vs Control Group 1: Non-inferiority comparison 2) Test Group vs Control Group 2: superiority comparison | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Secondary endpoint variables 1) Comparison of superiority of test group vs control group 1 of the primary endpoint 2) Change in the ratio of TIR within each range between visits 3 to 6 (12 weeks) compared to the TIR within each range between visits 1 to 3 confirmed by the sensor glucose value >300 mg/dL ? >250 mg/dL ? >180mg/dL ? <70mg/dL ? <54mg/dL ? Daytime (6AM to 12AM) and nighttime (12AM to 6AM) analysis of secondary endpoint 1) ? Mean glucose concentration (mg/dL), coefficient of variation % change between visits 3-6 (12 weeks) compared to visits 1-3 confirmed by sensor glucose values 3) Change in glycated hemoglobin (HbA1c) at end time (V6) compared to baseline (V3) 4) Changes in Glyco-albumin at the End Time (V6) compared to the Base Time (V3) 5) Changes in total daily dose between visits 3 and 6 (12 weeks) compared to between visits 1 and 3 6) Change in body weight (kg) at the end point (V6) compared to the baseline (V3) 7) Changes in treatment compliance between visits 3 and 6 (12 weeks) compared to visits 1-3 (average wearing days/months) 8) Changes from baseline (V0) to end time (V6) ITSQ (Insulin Treatment Satisfaction Questionnaire_Koean) and DTSQ-status (Diabetes treatment satisfaction questionnaire- status, 8 questionnaires_Korean) | — |
Countries
Korea, Republic of
Contacts
Public ContactCheolyoung Park
Kangbuk Samsung Medical Center
Outcome results
None listed