Adaptive Device for Insulin Pens for Arthritic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities

Conditions
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Diabetes Mellitus, Arthritis

Intervention / Treatment
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* Device: Pen device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (pen device)<br>Subjects will use the pen device when using their commercially available insulin pens | Device: Pen device<br>* Adaptive pen device<br>|
| No Intervention: Control<br>Subjects will use the commercially available insulin pens only (no adaptive pen device). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale for ease of use | Questionnaires re: efficacy and ease of use | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Arthritis