Adaptive Device for Insulin Pens for Arthritic Patients

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02779816
• Other study ID #: 2016-1
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: July 2, 2018

Study information

• Verified date: August 2019
• Source: Levenson, David I., M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Diabetes Mellitus

Intervention

Device:
• Pen device
Adaptive pen device

Locations

Country	Name	City	State
United States	East Coast Medical Associates	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Levenson, David I., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale for ease of use	Questionnaires re: efficacy and ease of use	one month