Evaluation of IFU for Max Plus LX3 monitoring system

• Research type

  Research Study

• Full title

  An evaluation of the comprehensibility and clarity of instructions for use (IFU) for a patient self-testing device used to measure glucose, ketones and cholesterol.

• IRAS ID

  228486

• Contact name

  Maurice O'Kane

• Contact email

  maurice.okane@westerntrust.hscni.net

• Sponsor organisation

  Nova Biomedical UK

• Duration of Study in the UK

  0 years, 6 months, 11 days

• Research summary

  A new monitoring system to test glucose, ketones and cholesterol has been developed. It is intended for use by people with diabetes at home as an aid to evaluate the effectiveness of diabetes and DKA (diabetic keto acidosis) control. This study will evaluate the comprehensibility and clarity of instructions for use of the Nova Max Plus LX3 monitoring system.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  17/EE/0218

• Date of REC Opinion

  2 Jun 2017

• REC opinion

  Further Information Favourable Opinion