![]() ![]() from the fingertip or the earlobe), the inconvenience and pain, and the costs associated with always using a new test strip, makes it a cumbersome procedure, which is disliked by the affected patients. The necessity to always obtain a capillary blood sample (e.g. It has been shown that more frequent assessment of glucose by the patient is associated with better glycemic control and in a reduction of overall morbidity and mortality. Keywords: Blood glucose monitoring Diabetes mellitus Non-invasive glucose monitoring Patient self-measurement Prediabetesīlood glucose measurement is a frequent procedure in the treatment of patients with diabetes mellitus and essential to prevent diabetic complications. The performance was similar in diabetes patients and prediabetes subjects.Ĭonclusions: The current data confirms the egm1000 device performance among its intended users, including pre-diabetic patients, for pain-free non-invasive monitoring of glucose levels. MARD vs, YSI of the Hemocue-calibrated egm1000 devices was found to be 19.7 % (17.5 % vs. Results: In the consensus error grid, 100 % of the egm1000 results were within the clinically accepted zones A and B (62.4 % and 37.6 %). ![]() Mean absolute relative difference (MARD) and a consensus error grid analysis were calculated against the YSI reference method. Blood glucose was measured every 30 min over 180 min with Hemocue, Accu Chek Performa and YSI Stat 2300. After prior individual calibration with a Hemocue blood glucose meter, the patients ingested a standardized breakfast at the site in the next morning. Methods: This device evaluation was performed in Germany and Egypt in summer 2016 with 27 participants (20 type 2 diabetes patients, 4 females, 68 ± 8 yrs HbA1c: 7.2 ± 1.0%, BMI: 32.1 ± 4.7 kg/m², and 7 prediabetic subjects, 2 women, HbA1c: 5.8 ± 0.3%, BMI: 30.4 ± 5.9 kg/m²). We performed this study to evaluate the performance of the device during a standardized meal test. The device assesses three physiological conditions at the earlobe, associated with tissue glucose concentrations (ultrasound, electromagnetic, and thermal). Objectives: The non-invasive egm1000 blood glucose monitoring device is the first CE-approved device for type 2 diabetes patients and prediabetes.
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