Diabetes MellitusNCT02779816
Adaptive Device for Insulin Pens for Arthritic Patients
A study testing Pen device in people with Diabetes Mellitus and Arthritis, run by Levenson, David I., M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Arthritis
- What is being tested?
- Pen device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 2 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Coast Medical Associates
Boca Raton, Florida, 33433
About this study
Official title: 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.
Read the 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
- Being tested
- Pen device
- Keywords
- Diabetes Mellitus, Arthritis
- Medical subject headings
- Diabetes Mellitus, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pen deviceDevice
Adaptive pen device
| Study group | Role | What they receive |
|---|---|---|
| Intervention (pen device) | Experimental | Subjects will use the pen device when using their commercially available insulin pens Receives: Device: Pen device |
| Control | No intervention | Subjects will use the commercially available insulin pens only (no adaptive pen device). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale for ease of use
Questionnaires re: efficacy and ease of use
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start1 May 2017
- Primary completion1 Jul 2018
- Study completion2 Jul 2018
Why it stopped: Lack of sufficient recruitment, other priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levenson, David I., M.D.
- Responsible party
- Principal investigator, David I. Levenson, MD, Levenson, David I., M.D.
- Investigators
- David I Levenson, MD, Principal investigator, East Coast Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779816
- Sponsor's protocol ID
- 2016-1
- Status last verified
- Aug 2019
- First submitted
- 15 May 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not until a patent is approved; after that, upon request
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities
- ClinicalTrials.gov ID
- NCT02779816
- Acronym / sponsor ID
- 2016-1
- Conditions
- Diabetes Mellitus, Arthritis
- Keywords
- Diabetes Mellitus, Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of sufficient recruitment, other priorities
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Levenson, David I., M.D.
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (pen device) | Experimental | Device: Pen deviceSubjects will use the pen device when using their commercially available insulin pens |
| Control | No intervention | –Subjects will use the commercially available insulin pens only (no adaptive pen device). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pen deviceAdaptive pen device | Device | Intervention (pen device) |
Primary outcome
Visual analog scale for ease of use
Time frame: one month
Questionnaires re: efficacy and ease of use
Results and safety
The study was stopped early (reason given: Lack of sufficient recruitment, other priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No. Not until a patent is approved; after that, upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David I Levenson, MD principal investigator
East Coast Medical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pen device in people with Diabetes Mellitus and Arthritis, run by Levenson, David I., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of sufficient recruitment, other priorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale for ease of use (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.