Efficacy and safety of Hybrid Closed Loop Automated Insulin Delivery System (EOPatch X) for comparative evaluation with Sensor Augmented Pump (EOPatch M) in the Type 1 diabetes
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008398
- Lead Sponsor
- EOFLOW
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 104
1.Adults over 19 ~ under 70 years old
2. Have been diagnosed with type 1 diabetes (T1D) for more than 12 months (= 12 months)
3. Those who have been using multiple daily insulin (MDI) or continuous subcutaneous insulin infusion (CSII) with a tubed insulin pump for more than 3 months
4. Those who are using Dexcom G6?, a Continuous Glucose Monitoring System (CGMS) for personal use, or have consented to use it during the clinical trial.
5. Those who have agreed to use one or more of the clinically appropriate contraceptive methods† during the clinical trial participation period.
† Clinically appropriate contraception is defined as [intrauterine device (e.g., loop, mirena), chemical blockade (spermicide) or subcutaneous implant contraceptive (e.g., Implanon)]] + physical blocking, tubal surgery or laparoscopic contraception (a type of tubal ligation) for women.
6. Those who voluntarily decide to participate in this clinical trial and have agreed in writing to the subject's explanation and consent form
7. Those who are willing to comply with the clinical trial protocol
[ Inclusion criteria for run-in phase: Check at Visit 3 baseline after the end of the run-in phase, before randomization]
8. Those who have completed both 1 and 2 of the run-in phases
1. Those diagnosed with other diabetes such as gestational diabetes and type 2 diabetes mellitus (T2D)
2. In case of severe hyperglycemia with an HbA1c screening test result of 10.0% or more (HbA1c=10.0%)
3. Those who have been hospitalized for a history of diabetic ketoacidosis (DKA) within 12 weeks (= 12 weeks) before the screening visit
4. Those who have received emergency treatment or have been hospitalized for severe hypoglycemia (Glucose < 54 mg/dL) with convulsions and loss of consciousness within 12 weeks (= 12 weeks) before the screening visit
5.Those with a body mass index (BMI) of 45 kg/m2 or more (= 45 kg/m2)
6.Those who have difficulty using investigational devices due to allergies to insulin (Humalog, NovoRapid) or acrylate-based skin adhesives
7. Those with unawareness of severe hypoglycemia
8. Persons on medication that may affect glucose metabolism (e.g. adrenocorticotropic hormone, immunosuppressant)
9. Those who continuously require MRI and CT scans and high frequency electrothermal therapy (diathermy)
10. Those with uncontrolled hypertension
11. Those on kidney dialysis
12. Those with liver dysfunction (AST or ALT > 3 times the upper limit of normal)
13. Those who have a history of coronary artery disease such as acute myocardial infarction unstable angina pectoris or stroke within 6 months (= 6 months) before the screening visit
14. Those with a history of pituitary hypofunction (except when maintaining normal hormone levels through hormone replacement therapy)
15.Thyroid stimulating hormone levels are not controlled due to goiter, etc. (TSH >10 mIU/L)
16.Pregnant or lactating women or women of childbearing potential who plan to become pregnant
17.Those who cannot read or have limited communication skills
18. Persons with mental illness (including those diagnosed with alcoholism or drug addiction)
19.Those who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening visit or within 5 times the half-life of the investigational drug, whichever is longer.
20. Persons who have undergone surgical treatment within 4 weeks prior to participation in this clinical trial or who are scheduled to undergo surgery during participation in the clinical trial (however, those who have undergone or plan to undergo hydrosurgery using a local anesthetic are not judged to be adverse events but are allowed to register at the discretion of the investigator.)
21. When the investigator judges that participation in the clinical trial is inappropriate because it may cause other ethical issues or may affect the clinical trial results
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time in Range (TIR, %) within the target blood glucose range (greater than 70 mg/dL but not more than 180 mg/dL)
- Secondary Outcome Measures
Name Time Method Blood sugar, Glycated hemoglobin (HbA1c), Insulin injection dose, Satisfaction Questionnaire Evaluation