None listed
Conditions
Interventions
Medical Device : A total of two test devices (CareSens Air) were attached to the back of the upper arm, one on the left and right, for 15 days.
Sponsors
i-sens
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 19 years 2. With Type I or Type II diabetes using intensive insulin treatment, or insulin treatment. - Intensive insulin treatment: a treatment that uses multiple daily insulin injections or an insulin pump. - Definition of intensive insulin treatment: 2 times or more daily injections with a combination of basal and bolus insulin - Definition of insulin treatment: At least one injection per day, regardless of insulin type 3. Stop to consume Xylose 24 hours prior to enrollment in this trial and agree to stop consuming Xylose for the duration of the trial (limitations of CareSens Dual). 4. Voluntarily decide to participate in this trial and provide written consent
Exclusion criteria
Exclusion criteria: 1. With any of the following skin abnormalities/diseases at the CGMS sensor attachment site - Severe psoriasis, recent burns or severe sunburn, severe eczema, severe scarring, extensive tattoos, dermatitis herpesiformis, severe rashes, staphylococcus aureus infection, etc. 2. Allergic to medical adhesives 3. Had a severe hypoglycemia event within 6 months prior to screening - Severe hypoglycemia: A seizure caused by hypoglycemia that results in loss of consciousness or requires emergency care. 4. Hematocrit (Hct) level of 65% (limitation of CareSens Dual) 5. Currently with anemic, hemoglobin (Hb) level of <13 g/dL (male) or <12 g/dL (female) (Limitations of venous blood collection for YSI 2300 STAT PLUS measurement). 6. Had diabetic ketoacidosis (DKA) within 6 months prior to screening. 7. Medical history of cerebrovascular disease and cardiovascular disease (ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmias, etc.) within 6 months prior to screening 8. Had epilepsy, syncope, or adrenal disease within 6 months prior to screening. 9. Currentlytake antibiotics for a chronic infectious disease (e.g., osteomyelitis, endocarditis) or medications that may affect glucose metabolism (e.g., steroids). However, may be enrolled if maintained on a stable dose for 3 months prior to screening and throughout the duration of this trial 10. Take or apply medications (e.g. Methimazole, Isoniazid) and substances (e.g. Resorcinol, P-Phenylenediamine) that may damage the YSI sensor system or cause false readings (See Appendix 7). 11. Dialysis for kidney disease 12. Donated blood within 2 months prior to screening 13. Scheduled X-ray, MRI, CT scan, radiofrequency heat treatment, diathermy, or focused ultrasound treatment that cannot be rescheduled during this trial. 14. Women who are pregnant, nursing, or planning to become pregnant within the duration of this trial or who do not agree to use adequate contraception 15. Participation in another clinical trial within 2 weeks prior to screening or currently participating in another clinical trial or planning to participate in another clinical trial during the duration of this trial 16. Have a level of education, knowledge, and language comprehension (at least secondary school education, able to recognize blood glucose and hygiene, able to understand Arabic numerals and basic words dealing with the device) that, in the opinion of the investigator, makes them unsuitable for this trial or inexperienced in using a portable device with a graphical user interface. Have any other condition that, in the opinion of the investigator, makes them unsuitable for this trial or may increase the risks associated with participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %20/20 Accuracy | — |
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 values in Zone A and Zone B of Consensus Error Grid;% Concurrence of CGMS readings;% Concurrence of CGMS rate of change;PARD (Precision absolute relative difference);Agreement of 'LOW' or 'HIGH' CGMS readings;Alert performance ;CGMS calibration stability;CGMS sensor stability ;CGMS life;CGMS readings;CGMS satisfaction | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Cheol young
Kangbuk Samsung Medical Center
Outcome results
None listed