Adaptive Device for Insulin Pens for Arthritic Patients

August 13, 2019 updated by: David I. Levenson, MD, Levenson, David I., M.D.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33433
        • East Coast Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Levenson, David I., M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 2, 2018

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not until a patent is approved; after that, upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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