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This is a multi center, one arm, open label and prospective study to assess the safety and usability of the Solo™ MicroPump Insulin Delivery System .
The study will include a 30 days treatment period with the Solo MicroPump with no special care required for maintaining glycemic control.
The study will consist of up to 5 visits and one follow up phone call one week after termination of the study.
Visit 1 includes eligibility, baseline evaluation and training in handling of the Solo™ System. If no additional practice is required patients will be enrolled. Visit 2 will commence and Solo pump will be filled with insulin. If additional practice is required subject will be sent home for an additional training period of a few days practice using saline and then return for visit 2.
Treatment visits will take place at 3, 14 and 30 days after the enrolment. Subjects will be asked to record blood glucose measurements, daily activities and carbohydrate consumptions between visits.
Seven days after termination of study treatment a telephone contact with the study subject will take place for the purpose of adverse event reporting and the completion of DTSQ questionnaire.
Measurements that will be used for assessing the safety of the device are glucose levels and any occurrence of AE's.
Subjects will complete DTSQ and Performance questionnaires before and at the end of the treatment period for usability evaluation.
Blood and urine tests will be taken at visit 1 and 5, vital signs and physical examination will be evaluated at all study visits.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Type 1 Diabetes
Medical University Graz
A - 8036
Published on BioPortfolio: 2014-08-27T03:16:22-0400
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A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
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