Adaptive Device for Insulin Pens for Arthritic Patients

NCT ID: NCT02779816

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-07-02

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.

Conditions

Diabetes Mellitus; Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Intervention (pen device)

Subjects will use the pen device when using their commercially available insulin pens

Group Type: EXPERIMENTAL

Pen device

Intervention Type: DEVICE

Adaptive pen device

Control

Subjects will use the commercially available insulin pens only (no adaptive pen device).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pen device

Adaptive pen device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Levenson, David I., M.D.

INDIV

Sponsor Role: lead

Responsible Party

David I. Levenson, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David I Levenson, MD

Role: PRINCIPAL_INVESTIGATOR

East Coast Medical Associates

Locations

East Coast Medical Associates

Boca Raton, Florida, United States

Countries

United States

Other Identifiers

2016-1

Identifier Type: -

Identifier Source: org_study_id