A clinical trial to evaluate the efficacy and safety of CareSens Air, a continuous glucose monitor, in adult patients with diabetes.
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009215
- Lead Sponsor
- i-sens
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 85
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
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 <15% or >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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method