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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accu-Chek® Insight Insulin Pump | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek® Insight Insulin Pump | Device | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures | 6 months | |
| Evaluate subject satisfaction based on surveys of important factors of health-related quality of life | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Petersen | Roche Diagnostics GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | 8036 | Austria | ||||
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|
| Evaluate change in HbA1c from screening to month 3 and 6 | 3 weeks screening plus 6 months treatment period |
| Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types) | 6 months |
| Evaluate change in CGM-derived parameters from month 3 to month 6 | 6 months |
| Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages | 6 months |
| Vienna |
| 1130 |
| Austria |
| Birmingham | B15 2WB | United Kingdom |
| Birmingham | B9 SSS | United Kingdom |
| Blackburn | BB23HH | United Kingdom |
| Leicester | LE15WW | United Kingdom |
| Middlesbrough | TS4 3BW | United Kingdom |
| Stafford | ST16 2ST | United Kingdom |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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