Accu-Chek® Insight Insulin Pump EU Study; Study Protocol RD001514

• Research type

  Research Study

• Full title

  Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice

• IRAS ID

  110444

• Contact name

  Rudy Bilous

• Contact email

  rudy.bilous@stees.nhs.uk

• Sponsor organisation

  Roche Diagnostics GmbH

• Research summary

  Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice

  Primary objective
  • To evaluate CSII therapy with the Accu-Chek® Insight insulin pump and associated pump devices
  Secondary objectives
  To evaluate the following parameters:
  • Type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
  • Type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
  • Subject satisfaction and important factors of health-related quality of life
  • Change in HbA1c from screening to month 3 and 6
  • Utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
  • Change in CGM-derived parameters from month 3 to month 6

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  13/LO/0291

• Date of REC Opinion

  30 May 2013

• REC opinion

  Further Information Favourable Opinion