Regular blood glucose self-testing is considered to be the most painful procedure during daily treatment routine for patients with diabetes mellitus. This pilot study was undertaken to evaluate the performance of TensorTip CoG, a non-invasive glucose monitoring device (NI-CoG, CNOGA Medical, Israel) on glycemic control and daily measurement aspects in patients with type 1 and type 2 diabetes.
The study was performed with 6 type 1 patients (T1D: 3 male/3 female, age: 43±16 years, HbA1c: 8.0±0.5%), and 15 type 2 patients (T2D: 8 male/7 female, 62±6 years, 7.2±1.3%). The participants used the NI-CoG device at home after an initial standardized meal experiment to evaluate device performance in comparison to a standard reference method (YSI Stat2300 plus). In addition, HbA1c was assessed and a treatment satisfaction questionnaire was completed after a period of three months of home use.
During the meal experiment, NI-CoG showed good accuracy (mean bias: 15.3%; consensus error grid: 100% in zones A and B). A trend for HbA1c improvement was seen in both groups over 3 months (T1D: -0.22%, T2D: -0.1%, n.s.). Patients reported to measure more frequently, and to feel more comfortable with the non-invasive measurement procedure. Use of the device in the study initiated the general desire to switch to the new device also for daily routine use.
The non-invasive TensorTip device was shown to increase the frequency of glucose testing and to have a positive impact on patients' perception of the measurement procedure. There was also an initial trend for improvements of glycemic control within the first three months of use in this pilot study.
A. Pfützner: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Lifecare. Speaker's Bureau; Self; Berlin-Chemie AG. Research Support; Self; Boehringer Ingelheim GmbH. A. Lier: None. S. Ramljak: None. F. Demircik: None.