Clinical trial NCT02105103: 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.
Official title: Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes, Type 1 Diabetes
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
timeFrame: 6 months
measure: Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
timeFrame: 6 months
measure: Evaluate change in HbA1c from screening to month 3 and 6
timeFrame: 3 weeks screening plus 6 months treatment period
measure: Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
timeFrame: 6 months
measure: Evaluate change in CGM-derived parameters from month 3 to month 6
timeFrame: 6 months
measure: Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
timeFrame: 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
city: Vienna
country: Austria
city: Birmingham
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Blackburn
country: United Kingdom
city: Leicester
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Stafford
country: United Kingdom
Study officials:
affiliation: Roche Diagnostics GmbH
name: Bettina Petersen
role: STUDY_DIRECTOR
References: