Back to resultsAdaptive Device for Insulin Pens for Arthritic Patients
Primary Purpose
Diabetes Mellitus, Arthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pen device
Sponsored by
About this trial
This is an interventional device feasibility trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Arthritis
Eligibility Criteria
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
Sites / Locations
- East Coast Medical Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (pen device)
Control
Arm Description
Subjects will use the pen device when using their commercially available insulin pens
Subjects will use the commercially available insulin pens only (no adaptive pen device).
Outcomes
Primary Outcome Measures
Visual analog scale for ease of use
Questionnaires re: efficacy and ease of use
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02779816
Brief Title
Adaptive Device for Insulin Pens for Arthritic Patients
Official Title
Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of sufficient recruitment, other priorities
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Levenson, David I., M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Arthritis
Keywords
Diabetes Mellitus, Arthritis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (pen device)
Arm Type
Experimental
Arm Description
Subjects will use the pen device when using their commercially available insulin pens
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will use the commercially available insulin pens only (no adaptive pen device).
Intervention Type
Device
Intervention Name(s)
Pen device
Intervention Description
Adaptive pen device
Primary Outcome Measure Information:
Title
Visual analog scale for ease of use
Description
Questionnaires re: efficacy and ease of use
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David I Levenson, MD
Organizational Affiliation
East Coast Medical Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Coast Medical Associates
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33433
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not until a patent is approved; after that, upon request
Learn more about this trial
Adaptive Device for Insulin Pens for Arthritic Patients
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