European, Open-label, Prospective, Multinational, Multicenter Study in Adult Subjects With Type 1 or Type 2 Diabetes Previously on MDI or CSII Therapy. Subjects Home Setting is Considered Routine Practice.
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or female at least 18 years old
- Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
- Intensive insulin therapy by MDI or CSII at least 6 months
- Willing to self monitor blood glucose 4 times daily
Exclusion criteria
- Significantly impaired awareness of hypoglycemia
- Unstable chronic disease other than diabetes
- Acute illness or inability to recognize pump signals or alarms as determined by the investigator
- Pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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