Diabetes Mellitus, Type 2NCT01852136
Clinical Evaluation of BD NEXT Pen Needle
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 5 sites in 2 countries.
Trial summary
This prospective, multi-center, 2 period cross-over study is designed to determine if people who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle (PN) in comparison with currently marketed pen needles of the same or similar gauge and length. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- BD NEXT 31G x 5 mm pen needle, BD NEXT 31G x 8mm pen needle and BD NEXT 32G x 4mm pen needle
- Type of treatment
- Medical device
- How many people
- 217 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2012to Dec 2012
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 1 or Type 2 diabetes.
- Currently self-injects insulin with a pen device at least once daily, and doing so for at least two months prior to enrollment.
- One or more daily insulin doses injected with the pen device must be > 10 units
- The insulin pen being used by the subject for the daily dose of > 10 units must be one of the three currently marketed pens: sanofi-aventis SoloSTAR, Lilly KwikPen, or Novo Nordisk FlexPen
- Using a pen needle that is either 4, 5, 6, or 8 mm length, and either 31 or 32 gauge.
- Willing to use the assigned study needles for all pen injections (including insulin and any other pen-based medications).
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- Willing to keep their diabetes medications, diet, and exercise the same during the study.
- Able to read, write and follow instructions in English.
- Able and willing to provide informed consent.
- The subject may also be using syringe and vial for some insulin doses, provided that at least one injection per day is done with an insulin pen and pen needle and is > 10 units.
Who cannot join
- Have previous knowledge of the details of this study or investigational products.
- Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Principal Investigator or Sub-Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (e.g., recent history of ketoacidosis, hypoglycemic unawareness, etc.).
- Currently participating in any other clinical investigation that conflicts with this one, or who have participated in a study with the same indication within the prior 30 days that the Principal Investigator or Sub-Investigator believes will conflict with outcomes or ability of the subject to complete all activities required in this study.
- Currently using either the Pic Indolor (Artsana) Insupen Sensitive 8 mm X 32G pen needle or the Pic Indolor (Artsana) Insupen Sensitive 6mm X 32G pen needle.
- History of intravenous drug use (self-reported).
- Employee, contractor or consultant to any company that manufactures pen needles, including BD.
- Pregnant (self-reported).
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Holston Medical Group
Kingsport, Tennessee, 37660
Physicians Research Center
Toms River, New Jersey, 08755
Corporation Lane Internal Medicine and Research Center
Virginia Beach, Virginia, 23462
About this study
Official title: Clinical Evaluation of the BD NEXT (Extra Thin Wall Pen Needles) Compared to the Currently Marketed Pen Needles
This prospective, multi-center, 2 period cross-over study is designed to determine if people who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle (PN) in comparison with currently marketed pen needles of the same or similar gauge and length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN each for one week in a randomly assigned sequence, and will be asked to evaluate and compare characteristics of the BD NEXT pen needle versus their usual pen needle when used for all their pen injections performed at home. Since injection experience may vary according to the type of pen device used, equal numbers of subjects will be recruited who are users of three of the most commonly used insulin pen injectors.
Read the detailed description
Using their usual insulin doses, pen and injection routine, subjects will be asked to compare two different pen needles (PNs) of corresponding gauge (GA) and length, one being the investigational (extra thin wall) pen needle and the other being their most often, currently used pen needle. Based on their current pen needle gauge and length, subjects will be assigned to the BD NEXT pen needle with the most comparable gauge (G) and length, in millimeters (mm). The three possible sizes are BD NEXT 32G x 4mm pen needle, BD NEXT 31G x 5mm pen needle, or BD NEXT 31G x 8 mm pen needle.
Both study pen needles will be used by the subject on the same pen device/insulin brand. If subjects are using two different pens, comparison data will be collected for both pen devices.
Each subject will participate in three study visits over the course of approximately 3 weeks. Study conduct will include two in-home use study periods each lasting approximately (1) one week.
During Visit 1, after subjects are enrolled and assigned to a pen device group, subjects will be randomly assigned to use the BD NEXT or their usual PN for use during a 1 week home use period (Period 1). After approximately 1 week, at Visit 2, subjects will be crossed-over to the other study PN per the randomization schedule.
After approximately 1 week of home use with the second study PN (Period 2), at Visit 3, subjects will be asked to complete Visual Analog Scales (VAS) and answer questions comparing their injection experiences with the two different PNs.
The primary and secondary objectives will be assessed for all pen users combined. In addition, preference, thumb force, and confidence in full dose delivery will be compared among the subsets of subjects using each of the following pen devices: sanofi-aventis SoloSTAR®, Lilly KwikPen™, Novo Nordisk FlexPen®. In order to achieve a minimum of 60 evaluable subjects in each of these pen user groups approximately 210 subjects will be enrolled (70 subjects per pen group).
- Being tested
- BD NEXT 31G x 5 mm pen needle, BD NEXT 31G x 8mm pen needle, BD NEXT 32G x 4mm pen needle
- Keywords
- pen needle, insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD NEXT 31G x 5 mm pen needleDevice
Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
BD NEXT 31G x 8mm pen needleDevice
Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
BD NEXT 32G x 4mm pen needleDevice
Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
| Study group | Role | What they receive |
|---|---|---|
| NEXT 31G x 5mm | Subjects will use their current pen needle or the BD NEXT 31G x 5mm pen needle for approximately one week (Period 1). The alternate pen needle will be used for one week in Period 2. Receives: Device: BD NEXT 31G x 5 mm pen needle | |
| NEXT 31G x 8mm | Subjects will use their current pen needle or the BD NEXT 31G x 8mm pen needle for approximately one week (Period 1). The alternate pen needle will be used for one week in Period 2. Receives: Device: BD NEXT 31G x 8mm pen needle | |
| NEXT 32G x 4mm | Subjects will use their current pen needle or the BD NEXT 32G x 4mm pen needle for approximately one week (Period 1). The alternate pen needle will be used for one week in Period 2. Receives: Device: BD NEXT 32G x 4mm pen needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pen Needle Preference
The primary objective was assessed using a 15 cm VAS. A vertical line drawn to the left of the VAS center mark indicates that the Study Period 1 PN was preferred more than the Study Period 2 PN. Those PNs will be scored in (-) mm (maximum score -75 mm). A vertical line drawn to the right of the VAS center mark indicates that the Study Period 2 PN was preferred more than the Study Period 1 PN. Those PNs will be scored in (+) mm (maximum score +75 mm). The sign of the reading will be adjusted depending on which PN was tested first, so that the readings will represent relative differences of Investigational PN and Current PN, with positive scores indicating preference for the investigational PN. The difference between the BD NEXT PN and subject's usual PN is statistically significant if the entire 95% confidence interval (CI) is either positive (BD NEXT preferred) or negative (current PN preferred) with respect to preference assessment.
Measured: End of Period 2, after using each assigned pen needle for 1 week
Secondary outcomes (4)
Relative perceived thumb force
Using a similar 15 cm VAS as for the primary objective, subjects will be asked to compare the BD NEXT with their usual marketed pen needle to assess relative perceived thumb force to deliver insulin. The VAS will be measured as described for the primary objective.
Measured: End of Period 2, after using each assigned PN for 1 week
Confidence in full dose delivery of insulin
Using a 15 cm VAS, at the final study visit subjects will be asked to compare the BD NEXT with their usual marketed pen needle to assess relative confidence in a full dose delivery of insulin. The VAS will be measured as described for the primary objective.
Measured: End of Period 2, after using each assigned PN for 1 week
Perceived injection time to deliver full dose of insulin
Subjects will use a 15 cm VAS to compare the BD NEXT with their usual marketed pen needle to assess relative perceived injection time to deliver the full dose. The VAS will be measured as described for the primary objective.
Measured: End of Period 2, after using each assigned PN for 1 week
Pen user group subset comparisons
The VAS responses for preference, thumb force required to deliver insulin and confidence in delivering a full dose by subjects when using the BD NEXT pen needle in comparison with their usual pen needles were compared among the subsets of subjects using each of the following pen devices: sanofi-aventis SoloSTAR®, Lilly KwikPen™, and Novo Nordisk FlexPen®.
Measured: End of Period 2, after using each assigned PN for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence J Hirsch, MD, Study director, BD Medical-Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852136
- Sponsor's protocol ID
- DBC-11-NEXXT01
- Status last verified
- Feb 2017
- First submitted
- 9 May 2013
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aronson R, Gibney MA, Oza K, Berube J, Kassler-Taub K, Hirsch L. Insulin pen needles: effects of extra-thin wall needle technology on preference, confidence, and other patient ratings. Clin Ther. 2013 Jul;35(7):923-933.e4. doi: 10.1016/j.clinthera.2013.05.020. Epub 2013 Jun 20.
PubMed 23790553
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the BD NEXT (Extra Thin Wall Pen Needles) Compared to the Currently Marketed Pen Needles
- ClinicalTrials.gov ID
- NCT01852136
- Acronym / sponsor ID
- DBC-11-NEXXT01
- Keywords
- pen needle, insulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 May 2013 (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.
This prospective, multi-center, 2 period cross-over study is designed to determine if people who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle (PN) in comparison with currently marketed pen needles of the same or similar gauge and length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN each for one week in a randomly assigned sequence, and will be asked to evaluate and compare characteristics of the BD NEXT pen needle versus their usual pen needle when used for all their pen injections performed at home. Since injection experience may vary according to the type of pen device used, equal numbers of subjects will be recruited who are users of three of the most commonly used insulin pen injectors.
Detailed description
Using their usual insulin doses, pen and injection routine, subjects will be asked to compare two different pen needles (PNs) of corresponding gauge (GA) and length, one being the investigational (extra thin wall) pen needle and the other being their most often, currently used pen needle. Based on their current pen needle gauge and length, subjects will be assigned to the BD NEXT pen needle with the most comparable gauge (G) and length, in millimeters (mm). The three possible sizes are BD NEXT 32G x 4mm pen needle, BD NEXT 31G x 5mm pen needle, or BD NEXT 31G x 8 mm pen needle.
Both study pen needles will be used by the subject on the same pen device/insulin brand. If subjects are using two different pens, comparison data will be collected for both pen devices.
Each subject will participate in three study visits over the course of approximately 3 weeks. Study conduct will include two in-home use study periods each lasting approximately (1) one week.
During Visit 1, after subjects are enrolled and assigned to a pen device group, subjects will be randomly assigned to use the BD NEXT or their usual PN for use during a 1 week home use period (Period 1). After approximately 1 week, at Visit 2, subjects will be crossed-over to the other study PN per the randomization schedule.
After approximately 1 week of home use with the second study PN (Period 2), at Visit 3, subjects will be asked to complete Visual Analog Scales (VAS) and answer questions comparing their injection experiences with the two different PNs.
The primary and secondary objectives will be assessed for all pen users combined. In addition, preference, thumb force, and confidence in full dose delivery will be compared among the subsets of subjects using each of the following pen devices: sanofi-aventis SoloSTAR®, Lilly KwikPen™, Novo Nordisk FlexPen®. In order to achieve a minimum of 60 evaluable subjects in each of these pen user groups approximately 210 subjects will be enrolled (70 subjects per pen group).
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEXT 31G x 5mm | – | Device: BD NEXT 31G x 5 mm pen needleSubjects will use their current pen needle or the BD NEXT 31G x 5mm pen needle for approximately one week (Period 1). The alternate pen needle will be used for one week in Period 2. |
| NEXT 31G x 8mm | – | Device: BD NEXT 31G x 8mm pen needleSubjects will use their current pen needle or the BD NEXT 31G x 8mm pen needle for approximately one week (Period 1). The alternate pen needle will be used for one week in Period 2. |
| NEXT 32G x 4mm | – | Device: BD NEXT 32G x 4mm pen needleSubjects will use their current pen needle or the BD NEXT 32G x 4mm pen needle for approximately one week (Period 1). The alternate pen needle will be used for one week in Period 2. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with Type 1 or Type 2 diabetes.
- Currently self-injects insulin with a pen device at least once daily, and doing so for at least two months prior to enrollment.
- One or more daily insulin doses injected with the pen device must be > 10 units
- The insulin pen being used by the subject for the daily dose of > 10 units must be one of the three currently marketed pens: sanofi-aventis SoloSTAR, Lilly KwikPen, or Novo Nordisk FlexPen
- Using a pen needle that is either 4, 5, 6, or 8 mm length, and either 31 or 32 gauge.
Key exclusion criteria (7 listed)
- Have previous knowledge of the details of this study or investigational products.
- Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Principal Investigator or Sub-Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (e.g., recent history of ketoacidosis, hypoglycemic unawareness, etc.).
- Currently participating in any other clinical investigation that conflicts with this one, or who have participated in a study with the same indication within the prior 30 days that the Principal Investigator or Sub-Investigator believes will conflict with outcomes or ability of the subject to complete all activities required in this study.
- Currently using either the Pic Indolor (Artsana) Insupen Sensitive 8 mm X 32G pen needle or the Pic Indolor (Artsana) Insupen Sensitive 6mm X 32G pen needle.
- History of intravenous drug use (self-reported).
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 |
|---|---|---|
| BD NEXT 31G x 5 mm pen needleEach pen needle type will be used for approximately one week. Subjects will use their current pen injector device. | Device | NEXT 31G x 5mm |
| BD NEXT 31G x 8mm pen needleEach pen needle type will be used for approximately one week. Subjects will use their current pen injector device. | Device | NEXT 31G x 8mm |
| BD NEXT 32G x 4mm pen needleEach pen needle type will be used for approximately one week. Subjects will use their current pen injector device. | Device | NEXT 32G x 4mm |
Primary outcome
Overall Pen Needle Preference
Time frame: End of Period 2, after using each assigned pen needle for 1 week
The primary objective was assessed using a 15 cm VAS. A vertical line drawn to the left of the VAS center mark indicates that the Study Period 1 PN was preferred more than the Study Period 2 PN. Those PNs will be scored in (-) mm (maximum score -75 mm). A vertical line drawn to the right of the VAS center mark indicates that the Study Period 2 PN was preferred more than the Study Period 1 PN. Those PNs will be scored in (+) mm (maximum score +75 mm). The sign of the reading will be adjusted depending on which PN was tested first, so that the readings will represent relative differences of Investigational PN and Current PN, with positive scores indicating preference for the investigational PN. The difference between the BD NEXT PN and subject's usual PN is statistically significant if the entire 95% confidence interval (CI) is either positive (BD NEXT preferred) or negative (current PN preferred) with respect to preference assessment.
4 secondary outcomes
Relative perceived thumb force
Time frame: End of Period 2, after using each assigned PN for 1 week
Confidence in full dose delivery of insulin
Time frame: End of Period 2, after using each assigned PN for 1 week
Perceived injection time to deliver full dose of insulin
Time frame: End of Period 2, after using each assigned PN for 1 week
Pen user group subset comparisons
Time frame: End of Period 2, after using each assigned PN for 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 23790553Aronson R, Gibney MA, Oza K, Berube J, Kassler-Taub K, Hirsch L. Insulin pen needles: effects of extra-thin wall needle technology on preference, confidence, and other patient ratings. Clin Ther. 2013 Jul;35(7):923-933.e4. doi: 10.1016/j.clinthera.2013.05.020. Epub 2013 Jun 20.
- Individual participant dataSharing planned: No
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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.
Laurence J Hirsch, MD study director
BD Medical-Diabetes Care
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 5 sites in 2 countries.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Pen Needle Preference (time frame: End of Period 2, after using each assigned pen needle for 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852136, which also lists 1 linked publication.
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 9 Feb 2017.