Adaptive Device for Insulin Pens for Arthritic Patients
Adaptive Device for Insulin Pens for Arthritic Patients
Approximately 34 subjects will be enrolled in an unblinded cross-over design. For one week,
 they will use the adaptive pen device and for the next week, they will use just the insulin
 (or other medication) pen. This will be repeated for another one week period each. At the end
 of each week, the subjects will fill out a questionnaire regarding their experiences and any
 suggestions for improvements for the design of the pen device.
This study is of an unblinded crossover design. Each patient will be randomly assigned to
 initiate a one week observation period with either the pen alone or the pen with the device.
 The following week, the patient will switch to the other assignment. This will be repeated
 one more time for a total of two weeks with the device and two weeks without it.

 At the end of every week, the patients will be given a questionnaire to fill out. Questions
 will include a measurement of their satisfaction with their insulin (or other medication)
 delivery system for that week. Patients will be instructed to continue their usual dosage of
 medication as prescribed by their physician. If the patients have any problems with the
 device or feel uncomfortable with it, they are instructed to discontinue use of the device
 and continue using their pen as usual.

 The patients may keep the device at the end of the study. The questionnaires that the
 patients fill out will be the primary source documents.
Inclusion Criteria:

 -  Currently using a pen to administer medication at least once a week

 -  Currently are having some difficulty (self reported) using their pens because of
 dexterity issues

 Exclusion Criteria:

 -  Woman of child-bearing age who are known to be pregnant

 -  People who are unable or unwilling to sign the informed consent document

 -  Patients who do not understand the proper use of the device after sufficient
 instruction

 -  Anyone in the Principal Investigator's judgment who cannot properly use the device