None listed
Conditions
Interventions
Medical Device : A total of two test devices (CareSens Air 2) were attached to the back of the upper arm, one on the left and right, for 18 days.
Sponsors
i-sens
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older 2. Subjects with type 1 or type 2 diabetes receiving insulin therapy* *Regardless of the type of insulin, at least one injection per day or using an insulin pump 3. Subjects who agree to discontinue xylose intake 24 hours prior to enrollment in this clinical trial and to continue to discontinue xylose intake for the duration of the clinical trial 4. For women of childbearing potential, subjects who agree to use a medically accepted method of contraception* during the clinical trial *Hormonal contraception, intrauterine device (IUD [Intrauterine device] or IUS [Intrauterine system]), tubal ligation, double barrier method (combined use of barrier methods such as male condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), and single barrier method with spermicide 5. Subjects who voluntarily decided to participate in this clinical trial and provided written consent
Exclusion criteria
Exclusion criteria: 1. If you have any of the following skin abnormalities/diseases at the CGMS application site: - Severe psoriasis, recent burns or severe sunburn, severe eczema, severe scarring, extensive tattoos, herpetic dermatitis, severe rash, Staphylococcus aureus infection, etc. 2. If you are allergic to medical adhesives 3. If you have experienced severe hypoglycemia within the 6 months prior to screening - Severe hypoglycemia: loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia 4. If your hematocrit (Hct) level is >70% 5. If you are currently anemic with a hemoglobin (Hb) level <10 g/dL 6. If you are taking dual antiplatelet therapy (aspirin plus one of the P2Y12 inhibitors Clopidogrel, Prasugrel, or Ticagrelor) 7. When collecting venous blood for YSI measurement using an intravenous catheter, taking or using medications (e.g., Methimazole, Isoniazid) or substances (e.g., Resorcinol, P-Phenylenediamine) that may damage the YSI sensor system or cause erroneous readings. 8. Having had diabetic ketoacidosis (DKA) within 6 months prior to screening. 9. Having a history of cerebrovascular disease or cardiovascular disease (ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmia, etc.) within 6 months prior to screening. 10. Having had epilepsy, syncope, or adrenal disease within 6 months prior to screening. 11. Taking antibiotics for a chronic infectious disease (e.g., osteomyelitis, endocarditis) or taking medications that may affect glucose metabolism (e.g., steroids). (However, enrollment is possible if a stable dosage is maintained for 3 months prior to screening and during the clinical trial period.) 12. If receiving dialysis for kidney disease. 13. If donating blood within 2 months prior to screening. 14. If scheduled MRI (magnetic resonance imaging), CT (computed tomography) scan, radiofrequency ablation, or diathermy treatment that cannot be rescheduled during this clinical trial period. 15. If pregnant or breastfeeding. 16. If participating in another clinical trial within 2 weeks prior to screening or currently participating in another clinical trial during this clinical trial period. 17. If the investigator determines that the level of education, knowledge, and language comprehension (secondary education or higher, ability to recognize blood sugar and hygiene, and ability to understand Arabic numerals and basic words for handling devices) is inadequate, or if the investigator does not have experience using a portable device with a graphical user interface, the applicant is not suitable for this clinical trial. 18. If the investigator determines that the applicant is not suitable for this clinical trial or that the risk associated with participation in the study may increase. ? Specific reasons are described in the case report form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %20/20 Accuracy;The occurrence of local and systemic adverse events was evaluated | — |
Secondary
| Measure | Time frame |
|---|---|
| %15/15, %20/20, %30/30, %40/40, >%40/40 Accuracy;MARD (Mean absolute relative difference);% CGMS values in Zone A and Zone B of Consensus Error Grid;Alert performance ;CGMS life | — |
Countries
Korea, Republic of
Contacts
Public ContactJaehyeon Kim
Samsung Medical Center
Outcome results
None listed