Background <p>Self-monitoring of blood glucose (SMBG) is crucial for maintaining good glycemic control, and NiproFS Next (NIPRO CORPORATION, Osaka, Japan), a latest model, has been released for the same. This study investigated the usability and basic performance of a self-blood glucose meter when switching from Nipro FreeStyle Freedom Lite (Abbott Diabetes Care Inc., Alameda, California) a previous model, to NiproFS Next.</p> Methods <p>After obtaining consent, usability evaluation was conducted on 50 patients who were using the old model. This evaluation was conducted using a four-point scale to assess the following usability aspects: ease of holding, ease of operation, visibility of the measurement results, and ease of disposal of the test strips. Although “ease of use of the rechargeable battery” was included in the questionnaire, it was excluded from the final analysis because of insufficient data. Basic performance evaluations were performed using heparinized blood collected from 15 consenting healthy individuals to examine accuracy, reproducibility, and effects of seven types of interfering substances, hematocrit, and environmental temperature.</p> Results <p>In the usability evaluation, most opinions were that operability, ease of holding the device, and visibility were good. However, understanding volume adjustment on the new model was challenging. Although accuracy was good in the basic performance evaluation, the assay was affected by interfering substances such as ascorbic acid, xylose, hematocrit, and low-temperature environments.</p> Conclusions <p>Patients with diabetes can safely use the new model for managing their blood glucose levels; however, individualized guidance must be provided.</p>

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Evaluation of operability and basic performance when switching to a new simple blood glucose self-monitoring device

  • Hidetoshi Abe,
  • Kazuko Takeuchi,
  • Hanako Otaka,
  • Yasushi Kanazawa

摘要

Background

Self-monitoring of blood glucose (SMBG) is crucial for maintaining good glycemic control, and NiproFS Next (NIPRO CORPORATION, Osaka, Japan), a latest model, has been released for the same. This study investigated the usability and basic performance of a self-blood glucose meter when switching from Nipro FreeStyle Freedom Lite (Abbott Diabetes Care Inc., Alameda, California) a previous model, to NiproFS Next.

Methods

After obtaining consent, usability evaluation was conducted on 50 patients who were using the old model. This evaluation was conducted using a four-point scale to assess the following usability aspects: ease of holding, ease of operation, visibility of the measurement results, and ease of disposal of the test strips. Although “ease of use of the rechargeable battery” was included in the questionnaire, it was excluded from the final analysis because of insufficient data. Basic performance evaluations were performed using heparinized blood collected from 15 consenting healthy individuals to examine accuracy, reproducibility, and effects of seven types of interfering substances, hematocrit, and environmental temperature.

Results

In the usability evaluation, most opinions were that operability, ease of holding the device, and visibility were good. However, understanding volume adjustment on the new model was challenging. Although accuracy was good in the basic performance evaluation, the assay was affected by interfering substances such as ascorbic acid, xylose, hematocrit, and low-temperature environments.

Conclusions

Patients with diabetes can safely use the new model for managing their blood glucose levels; however, individualized guidance must be provided.