KCT0006405尚未招募未知
A Multi-center, Randomized, Open label, Post Marketing Surveillance of the Safety and Efficacy of Patch Insulin Pump (EOPatchM) Among Poorly Controlled Type 2 Diabetes Patients Treated with Multiple Daily Insulin or Multiple Pre-mixed Insulin
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 70?(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •[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
研究者
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