Type 1 Diabetes Clinical Trial
Official title:
Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin
Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial
Many subjects with Type 1 diabetes continue to manage their disease utilizing multiple daily
injections, but despite frequent blood glucose checks, are unable to control their glycemic
variability or lower their A1C levels. The MiniMed Paradigm REAL-Time System transmits
sensor glucose values to the insulin pump every 5 minutes, allowing users to view their
current glucose values as well as glycemic excursions and trends over a 24-hour period. The
System will also alert users of high and low glucose levels, allowing subjects and their
clinicians to make carefully monitored modifications to therapy. Additionally, data can be
uploaded from the monitor into a personal computer, allowing the subject and clinician to
see a complete picture of trends over time.
Subjects learning this technology would require a new approach to training if they were to
master operation of an insulin pump, make effective use of the sensor technology and
understand the complete picture provided by the software component. Subjects will be trained
to first use the insulin pump, add the sensor and then utilize the software and the
effectiveness of the training methods and timing will be measured using questionnaires
designed to evaluate understanding of the device, Self Efficacy and User Acceptance. The
group wearing the System will also be compared to subjects that continue on their current
MDI therapy over a 15-week time period.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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