None listed
Conditions
Interventions
Medical Device : One CareSens Air sensor and one each of the Dexcom G7 and FreeStyle Libre 2 sensors will be simultaneously attached to the posterior aspect of the left or right upper arm.
The CareSen
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. Presence of skin abnormalities or conditions at the intended sensor application sites for CareSens Air, Dexcom G7, or FreeStyle Libre 2, including but not limited to: - Severe psoriasis, recent burns or severe sunburn, severe eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, severe rash, or Staphylococcus aureus infection. 2. Known allergy to medical adhesives. 3. History of severe hypoglycemia within 6 months prior to screening. - Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizures requiring emergency medical intervention. 4. Hematocrit (Hct) >70% at screening. 5. History of diabetic ketoacidosis (DKA) within 6 months prior to screening. 6. History of cerebrovascular disease or cardiovascular disease (including ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, or clinically significant arrhythmia) within 6 months prior to screening. 7. History of epilepsy, syncope, or adrenal disease within 6 months prior to screening. 8. Currently receiving antibiotics for chronic infectious diseases (e.g., osteomyelitis or endocarditis) or taking medications that may affect glucose metabolism (e.g., corticosteroids), unless the dosage has remained stable for at least 3 months prior to screening and is expected to remain stable throughout the study. 9. Currently undergoing dialysis for renal disease. 10. Donation of blood within 2 months prior to screening. 11. Scheduled to undergo magnetic resonance imaging (MRI), computed tomography (CT), radiofrequency thermal therapy, or diathermy during the study period when the procedure cannot be rescheduled. 12. Pregnant or breastfeeding women. 13. Participation in another clinical trial within 2 weeks prior to screening, current participation in another clinical trial, or planned participation in another clinical trial during the study period. 14. Considered unsuitable for participation by the investigator due to inadequate education, knowledge, or language comprehension (e.g., below secondary education level, inability to recognize blood glucose or hygiene requirements, inability to understand Arabic numerals or basic device-related terminology), or lack of experience using a handheld device with a graphical user interface. 15. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study or may increase the risk associated with study participation. ? The specific reason shall be documented in the case report form (CRF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %20/20 Accuracy ([% of CGMS values within ±20 % of relative difference of reference value at glucose levels =100 mg/dL(4.4 mmol/L) and ±20 mg/dL of absolute difference at glucose level <100 mg/dL(1.11 mmol/L) (%20/20)]);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);MRD (Mean relative difference);MAD (Mean absolute difference);MD (Mean difference);% CGMS(continuous glucose monitoring system) values in Zone A and Zone B of Consensus Error Grid;% Concurrence of CGMS(continuous glucose monitoring system) readings;Trend accuracy (% Concurrence of CGMS(continuous glucose monitoring system) rate of change);Agreement of ‘LOW’ or ‘HIGH’ CGMS(continuous glucose monitoring system) readings;Alert performance;CGMS(continuous glucose monitoring system) life;% CGMS(continuous glucose monitoring system) readings | — |
Countries
Korea, Republic of
Contacts
Public ContactJaehyeon Kim
Samsung Medical Center
Outcome results
None listed