A Multi-center, Single group, clinical trial after authorization to evaluate the efficacy and safety of EOPatchM (A Sensor Augmented Pump) for Type 1 diabetes patients.
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0006372
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
1)Adult male and female over the age of 19
2)Those who have been diagnosed with type 1 diabetes for at least 6 months prior and who have used MDI (Multiple Daily Injection) or insulin pump for more than 3 months.
3)Those who have a type 1 diabetes with HbA1c less than 7.5% recently.
4)Those who are judged to be able to manage their diabetes through insulin administration and glucose monitoring based on the assessment of the Investigator at the screening visit.
5)Those who have voluntarily signed the informed consent form.
1)Those diagnosed with other diabetes such as gestational diabetes and type 2 diabetes (T2D)
2)Those who have been hospitalized with a history of diabetic ketoacidosis (DKA) within 12 weeks (= 12 weeks) prior to the screening visit.
3)Those who received emergency treatment or were hospitalized for severe hypoglycemia (Glucose < 54 mg/dL) with convulsions and loss of consciousness within 12 weeks (= 12 weeks) prior to the screening visit.
4)Those who have grade 4 or more chronic kidney functions (eGFR below 30 ? /min/1.73 ?) or dialysis.
5)Those with acute cardiovascular disease within the last three months.
6)Those who have malignant tumor under treatment during the Screening visit.
7)Those with liver dysfunction (AST or ALT > 3 times the upper limit of normal)
8)Those who have gastrointestinal disorders such as repeated diarrhea, vomiting, and severe gastroparesis.
9)Those who have pregnant and breast feeding or expecting to be pregnant.
10)Those who have variable insulin requirements (pre-operative, severe trauma, feverish infections, etc.).
11)Those who have Allergic to acrylic adhesive tape.
12)Excessive alcohol consumption (=420 g/week, about 7 bottles/week of soju, 1 bottle/day) or alcoholics.
13)Those who engaged in dangerous work, such as working in a high position.
14)Those who have difficulty using Investigational devices for clinical trials due to allergies to insulin (Humalog, Novo Rapid) or acrylate-based skin adhesives.
15)Those with unawareness of severe hypoglycemia.
16)Anyone who unfit to participate in clinical trials
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method