Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
A new insulin pump, the Accu-Chek® Insight insulin pump, will be used by all subjects enrolled in this study. The usability of the Accu-Chek® Insight insulin pump for the intended use has already been investigated in a Human Factor study. The study subjects may encounter the following potential risks of CSII therapy while participating in the study: Possible hypoglycemia; Possible hyperglycemia which might progress to ketosis and DKA; Infusion site reactions (bleeding, bruising, discomfort, pruritus, pain, plaster reactions, inflammation, infection etc.)
Unnamed facility
Graz, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Blackburn, United Kingdom
Unnamed facility
Leicester, United Kingdom
Unnamed facility
Middlesbrough, United Kingdom
Unnamed facility
Stafford, United Kingdom
The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).
Time frame: 6 months
Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
Time frame: 6 months
Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
Time frame: 6 months
Evaluate change in HbA1c from screening to month 3 and 6
Time frame: 3 weeks screening plus 6 months treatment period
Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
Time frame: 6 months
Evaluate change in CGM-derived parameters from month 3 to month 6
Time frame: 6 months
Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.