Adaptive Device for Insulin Pens for Arthritic Patients | NCT02779816

Studies
Adaptive Device for Insulin Pens for Arthritic Patients

NCT02779816

Sponsor

Levenson, David I., M.D.

Status

Terminated

Last Update Posted

Aug 14, 2019Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus
Arthritis

Interventions

Pen device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of sufficient recruitment, other priorities

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Jul 1, 2018Actual

Completion Date

Jul 2, 2018Actual

First Submitted Date

May 15, 2016

First Submission Date that Met QC Criteria

May 19, 2016

First Posted Date

May 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2019

Last Update Posted Date

Aug 14, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David I. Levenson, MD, PI, Levenson, David I., M.D.Principal Investigator

Lead Sponsor

Levenson, David I., M.D.INDIV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pen device	Device	Adaptive pen device	Intervention (pen device)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David I Levenson, MD	East Coast Medical Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
East Coast Medical Associates		Boca Raton	Florida	33433	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D001168	Arthritis

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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