Feasibility Study of the Solo™ Insulin Pump
The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study of the Solo™ Insulin Pump|
- Device-related adverse outcome [ Time Frame: During treatment period ] [ Designated as safety issue: Yes ]
- Mechanical dysfunction and diabetes-related adverse outcome [ Time Frame: During treatment period ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|Experimental: Solo MicroPump||
Device: Solo MicroPump
30 days treatment days with an optional extension period of up to 6 month of treatment.
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 and with an optional extension period of up to six month.
The study will consist of up to 5 visits and one follow up phone call one week after termination of the study. In case of participating the extension period, additional visits will consist once a month.
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. Additional visits will take place at 60, 90 and 180 days depending on the extension period.
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.