The use of a CoolSense device to lower pain sensation during finger pricking while measuring blood glucose in diabetes patients--a randomized placebo.

Background: Patients with type 1 diabetes and a significant portion of patients with type 2 diabetes must use subcutaneous insulin injections, in order to maintain normoglycemia and to prevent immediate and long-term complications. For these patients, testing blood glucose levels more frequently is necessary to safely achieve glycated hemoglobin targets. In the current study, the effects of a CoolSense™ device (CoolSense Medical Ltd., Tel Aviv, Israel) were examined in relieving pain caused by needle-pricking for glucose measurements in adult patients with diabetes.

Subjects And Methods: One hundred seventy-seven patients assessed the severity of pain they experienced during needle-pricking. The patients were randomly divided into an experimental group or a control group that used either a cooled CoolSense instrument or a non-cooled device, respectively. Participants were asked to rank the severity of their pain by a questionnaire developed for this study. Blood glucose levels were monitored as a control.

Results: The majority of participants (58.3-71.7%; P<0.001) reported significant ache during measurements, the desire for an instrument that relieves pain, and its negative influence on their quality of life. Significant differences were indicated in pain perception between the experimental group and the control group that served as placebo, with no differences in blood glucose measurements in the groups.

Conclusions: The CoolSense instrument significantly reduces subjective pain felt by patients and can therefore serve as an additional tool for clinicians to help ease the needle-pricking pain. Future study is needed in order to provide information regarding the practical use of the instrument and its effect on hyper- and hypoglycemia.