Adaptive Device for Insulin Pens for Arthritic Patients

NCT02779816 | Terminated FDA Device

• 1 other identifier: 2016-1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Arthritis

Keywords

Diabetes Mellitus; Arthritis

Outcome Measures

Primary Outcomes (1)

• Visual analog scale for ease of use

  Questionnaires re: efficacy and ease of use

  one month

Study Arms (2)

Intervention (pen device)

EXPERIMENTAL

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

Device: Pen device

Control

NO INTERVENTION

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

Interventions

Pen device DEVICE

Adaptive pen device

Intervention (pen device)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Levenson, David I., M.D.: lead

Study Sites (1)

East Coast Medical Associates

Boca Raton, Florida, 33433, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Arthritis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Joint Diseases; Musculoskeletal Diseases

Study Officials

• David I Levenson, MD

  East Coast Medical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 20, 2016
• Study Start: May 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 2, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)