None listed
Conditions
Interventions
Medical Device : A total of two test devices (CareSens Air 2) were attached for 18 days, one to each upper arm. For participants aged 2–5 years, one device was attached to the upper arm and the other
Sponsors
i-sens
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged at least 2 years to 18 years (2=N=18) 2. 'Has type I or type II diabetes and is receiving insulin treatment'¶ ¶Regardless of insulin type, uses an injection at least once a day or an insulin pump 3. Agrees to stop taking xylose 24 hours before enrolling in this clinical trial and during the clinical trial (restrictions for Contour Plus ONE). 4. For women of childbearing potential, those who agree to use the medically allowed contraceptive methods* during the clinical trial. * Oral hormonal contraceptives (estrogen and progestogen containing or progestogen only), male condom or female condom with or without spermicide 5. The participant voluntarily or the representative (legal guardian) agrees to participate in this clinical trial and provides written consent.
Exclusion criteria
Exclusion criteria: 1. Has following skin abnormalities/diseases at the site of CGMS(continuous glucose monitoring system) attachment: - Serious psoriasis, recent burn or serious sunburn, serious eczema, serious scarring, extensive tattoos, herpetic dermatitis, serious rash, Staphylococcus aureus infection, and others. 2. Allergic to medical adhesives 3. A severe hypoglycemia event within 6 months prior to Screening. - severe hypoglycemia: fainting due to hypoglycemia or a seizure requiring urgent medical care 4. Hematocrit (Hct) level of >70% 5. Hemoglobin (Hb) level of <10 g/dL or currently anemic 6. Receiving dual antiplatelet therapy (aspirin combined with a P2Y12 inhibitor (1 of clopidogrel, prasugrel or ticagrelor) 7. Diabetic ketoacidosis (DKA) within 6 months prior to Screening. 8. A history of cerebrovascular disease or cardiovascular disease (e.g., ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease and serious arrhythmia) within 6 months prior to Screening. 9. Epilepsy, sycope, or adrenal disease within 6 months prior to Screening. 10. Taking antibotics for a chronic infectious disease (e.g., osteomyelitis, endocarditis) or medications that may affect glucose metabolism (e.g., steroids). However, enrollment is allowed if a stable dosage is maintained for 3 months prior to Screening and during the clinical trial. 11. On dialysis for kidney disease. 12. Donated blood within 2 months prior to Screening. 13. Scheduled for MRI (magnetic resonance imaging) scan, CT (computed tomography) scan, radiofrequency ablation, or diathermy during the clinical trial that cannot be rescheduled. 14. Pregnant or breastfeeding individual. 15. Participation in another clinical trial within 2 weeks prior to Screening or while in this clinical trial or scheduled for participation in another trial during this clinical trial. 16. Deemed by the investigator the participant or the representative (legal guardian) is not suitable for this clinical trial due to inadequate education, knowledge, and language comprehension (secondary education or higher, awareness of blood glucose and hygiene, understanding of Arabic numerals and basic terms for handling devices), or lack of experience using a handheld device with a graphical user interface. 17. Other reasons deemed by the investigator not suitable for this clinical trial or to increase the risks associated with participation in the clinical trial. ? Detailed reasons to be recorded in the case report form (CRF)
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);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);MARoC (Mean absolute rate of change);PARD (Precision absolute relative difference);Agreement of ‘LOW’ or ‘HIGH’ CGMS(continuous glucose monitoring system) readings;Alert performance;CGMS(continuous glucose monitoring system) calibration interval stability;CGMS(continuous glucose monitoring system) sensor stability;CGMS(continuous glucose monitoring system) life;Sensor life;% CGMS(continuous glucose monitoring system) readings;CGMS(continuous glucose monitoring system) satisfaction;Predictive alert performance | — |
Countries
Korea, Republic of
Contacts
Public ContactJaehyun Kim
Seoul National University Bundang Hospital
Outcome results
None listed