DiabetesNCT03878745
Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
A study testing Terumo Nanopass® 34G pen needle and BD Nano™ PRO 32G pen needle in people with Diabetes, run by Becton, Dickinson and Company at 2 sites in United States.
Trial summary
This is a subject single blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. the thinner commercially available Terumo Nanopass® pen needle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Terumo Nanopass® 34G pen needle and BD Nano™ PRO 32G pen needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2019to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-attesting Japanese American adults 18 to 75 years of age (inclusive).
- Self-attest to Japanese descent.
- Diagnosed with Type 1 or Type 2 diabetes.
- Self-injecting using an injection pen for ≥3 months with any pen needle.
- Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day.
- Able to demonstrate proficiency using an injection pen into an injection model.
- Able and willing to provide informed consent.
- Able and willing to complete all study procedures.
Who cannot join
- Not self-injecting (for example injections completed by a family member).
- Self-injecting with a pen injector for less than 3 months.
- Unwilling to inject into abdomen.
- Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation.
- Failure to confirm which pen needle (gauge and needle length) subject is currently using. To confirm, subject may be asked to bring their pen and pen needles to the site or site staff may confirm via medical record or pharmacy.
- Pregnant (self-attestation).
Show all 15Show fewer
- Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin is permitted).
- History of a bleeding disorder.
- History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema).
- Gross skin anomalies and abnormalities located at or very close to the injection sites that would significantly limit available injection space.
- History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
- Use of any analgesic medications within 24 hours of first study injection, and during the study (up to 162 mg per day of aspirin is permitted).
- A current or previous medical or physical condition that, in the opinion of the investigator, would place the patient at risk or make them unable to perform study procedures or has the potential to confound interpretation of the study results.
- Currently participating in another pen needle study.
- Employed by, or currently serving as a contractor or consultant to BD or any diabetes injectable medication, injection pen, or pen needle manufacturer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
East West Medical Research Institute
Honolulu, Hawaii, 96814
Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute
San Mateo, California, 94401
About this study
This is a subject single blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. the thinner commercially available Terumo Nanopass® pen needle. The study will include a minimum of 55 Japanese American study subjects with Type 1 or Type 2 diabetes.
Read the detailed description
Study conduct will consist of one 60 to 120-minute Site visit in which pre-set doses of saline will be abdominally delivered by Subjects via a reusable insulin pen device. All pen needles will be attached by Study Staff and pen needle outer cover and inner shield will be removed for subjects. Subjects are to perform 12 injections into the abdomen (6 pairs of injections). Pairs of injections will be evaluated and each pair will contain one BD Nano™ PRO and one Terumo Nanopass® pen needle. The order of the two pen needles in each pair will be randomized.
The intent of this comparative use study is to determine whether Japanese American patients' experiences are different when using the BD Nano™ PRO 4mm x 32G extra thin wall, 5-bevel pen needle vs the Terumo Nanopass® 4mm x 34G pen needle in the Japanese American population. These experiences include the perceived force to deliver dose, the ability to deliver the full dose (measured by leakage), injection pain and bending.
- Conditions
- Diabetes
- Being tested
- Terumo Nanopass® 34G pen needle, BD Nano™ PRO 32G pen needle
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terumo Nanopass® 34G pen needleDevice
Insulin pen needle
BD Nano™ PRO 32G pen needleDevice
Insulin pen needle
| Study group | Role | What they receive |
|---|---|---|
| BD Nano™ PRO 32G pen needle | Experimental | Participants are to perform 6 pairs of injections. Receives: Device: Terumo Nanopass® 34G pen needle; Device: BD Nano™ PRO 32G pen needle |
| Terumo Nanopass® 34G pen needle | Active comparator | Participants are to perform 6 pairs of injections. Receives: Device: Terumo Nanopass® 34G pen needle; Device: BD Nano™ PRO 32G pen needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)
Injection pain as measured by a relative 150mm visual analog scale. Injection pain as measured by a relative visual analog scale. s. User preference is assessed through a single question reported on a 150mm relative VAS scale with the BD Nano™ PRO pen needle Pen labeled at +75 mm and the Comparator pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference forBD Nano™ PRO and negative scores reflect preference for the comparator.
Scores from each of the paired injections (330 pairs for all participants) were pooled and a mean was calculated. The two-sided 95% confidence interval was calcuated for the average relative rating. A linear model was used to adjust for the order effect.
If the lower bound of the 95% CI is > -10cm, non-inferiority could be concluded. If the lower bound of the 95% CI is >0, superiority can also be concluded.
Measured: Scores were collected immediately after each paired injection
Secondary outcomes (3)
BD Nano™ PRO vs Terumo Nanopass® (Force)
Subject perceived force required to deliver dose measured by a relative 5 point Likert scale. The scale ranged from -2 to 2, where positive scores indicated less thumb force required for the BD Nano™ PRO, and negative scores indicated less thumb force for Terumo Nanopass®. Scores from each of the paired injections (330 pairs for all participants) were pooled and a mean was calculated.
Measured: Scores were collected immediately after each paired injection
BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)
Participants reported a visual score of needle bending. A score of at least 2, corresponding to >10 degrees of bending, was considered an event of a bent needle. The percentage of of bending events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.
Measured: Immediately after injections were completed
BD Nano™ PRO vs Terumo Nanopass® (Leakage)
After saline delivery equivalent to 30U of U100 insulin (0.3mL) and subject removal of pen needle from body, study staff used the provided materials and scale to absorb leakage from the pen needle tip and injection site to measure the amount of leakage. Leakage over 0.015g was counted as an event. The percentage of of leakage events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.
Measured: Immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start11 Feb 2019
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878745
- Sponsor's protocol ID
- DBC-18PENDL01
- Status last verified
- May 2020
- First submitted
- 14 Mar 2019
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
PubMed 11690726Watson PJ, Latif RK, Rowbotham DJ. Ethnic differences in thermal pain responses: a comparison of South Asian and White British healthy males. Pain. 2005 Nov;118(1-2):194-200. doi: 10.1016/j.pain.2005.08.010. Epub 2005 Oct 3.
PubMed 16202529Palmer B, Macfarlane G, Afzal C, Esmail A, Silman A, Lunt M. Acculturation and the prevalence of pain amongst South Asian minority ethnic groups in the UK. Rheumatology (Oxford). 2007 Jun;46(6):1009-14. doi: 10.1093/rheumatology/kem037. Epub 2007 Mar 31.
PubMed 17401133Komiyama O, Kawara M, De Laat A. Ethnic differences regarding tactile and pain thresholds in the trigeminal region. J Pain. 2007 Apr;8(4):363-9. doi: 10.1016/j.jpain.2006.12.002. Epub 2007 Feb 1.
PubMed 17275416Hobara M. Beliefs about appropriate pain behavior: cross-cultural and sex differences between Japanese and Euro-Americans. Eur J Pain. 2005 Aug;9(4):389-93. doi: 10.1016/j.ejpain.2004.09.006.
PubMed 15979019Gibney MA, Fitz-Patrick D, Klonoff DC, Whooley S, Lu B, Yue W, Glezer S. User experiences with second-generation 32-gauge x 4 mm vs. thinner comparator pen needles: prospective randomized trial. Curr Med Res Opin. 2020 Oct;36(10):1591-1600. doi: 10.1080/03007995.2020.1803248. Epub 2020 Aug 18.
PubMed 32723109
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
- ClinicalTrials.gov ID
- NCT03878745
- Acronym / sponsor ID
- DBC-18PENDL01
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a subject single blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. the thinner commercially available Terumo Nanopass® pen needle. The study will include a minimum of 55 Japanese American study subjects with Type 1 or Type 2 diabetes.
Detailed description
Study conduct will consist of one 60 to 120-minute Site visit in which pre-set doses of saline will be abdominally delivered by Subjects via a reusable insulin pen device. All pen needles will be attached by Study Staff and pen needle outer cover and inner shield will be removed for subjects. Subjects are to perform 12 injections into the abdomen (6 pairs of injections). Pairs of injections will be evaluated and each pair will contain one BD Nano™ PRO and one Terumo Nanopass® pen needle. The order of the two pen needles in each pair will be randomized.
The intent of this comparative use study is to determine whether Japanese American patients' experiences are different when using the BD Nano™ PRO 4mm x 32G extra thin wall, 5-bevel pen needle vs the Terumo Nanopass® 4mm x 34G pen needle in the Japanese American population. These experiences include the perceived force to deliver dose, the ability to deliver the full dose (measured by leakage), injection pain and bending.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
| Arm | Type | Receives |
|---|---|---|
| BD Nano™ PRO 32G pen needle | Experimental | Device: Terumo Nanopass® 34G pen needle, Device: BD Nano™ PRO 32G pen needleParticipants are to perform 6 pairs of injections. |
| Terumo Nanopass® 34G pen needle | Active comparator | Device: Terumo Nanopass® 34G pen needle, Device: BD Nano™ PRO 32G pen needleParticipants are to perform 6 pairs of injections. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-attesting Japanese American adults 18 to 75 years of age (inclusive).
- Self-attest to Japanese descent.
- Diagnosed with Type 1 or Type 2 diabetes.
- Self-injecting using an injection pen for ≥3 months with any pen needle.
- Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day.
Key exclusion criteria (15 listed)
- Not self-injecting (for example injections completed by a family member).
- Self-injecting with a pen injector for less than 3 months.
- Unwilling to inject into abdomen.
- Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation.
- Failure to confirm which pen needle (gauge and needle length) subject is currently using. To confirm, subject may be asked to bring their pen and pen needles to the site or site staff may confirm via medical record or pharmacy.
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 |
|---|---|---|
| Terumo Nanopass® 34G pen needleInsulin pen needle | Device | BD Nano™ PRO 32G pen needle, Terumo Nanopass® 34G pen needle |
| BD Nano™ PRO 32G pen needleInsulin pen needle | Device | BD Nano™ PRO 32G pen needle, Terumo Nanopass® 34G pen needle |
Primary outcome
BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain)
Time frame: Scores were collected immediately after each paired injection
Injection pain as measured by a relative 150mm visual analog scale. Injection pain as measured by a relative visual analog scale. s. User preference is assessed through a single question reported on a 150mm relative VAS scale with the BD Nano™ PRO pen needle Pen labeled at +75 mm and the Comparator pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference forBD Nano™ PRO and negative scores reflect preference for the comparator. Scores from each of the paired injections (330 pairs for all participants) were pooled and a mean was calculated. The two-sided 95% confidence interval was calcuated for the average relative rating. A linear model was used to adjust for the order effect. If the lower bound of the 95% CI is > -10cm, non-inferiority could be concluded. If the lower bound of the 95% CI is >0, superiority can also be concluded.
3 secondary outcomes
BD Nano™ PRO vs Terumo Nanopass® (Force)
Time frame: Scores were collected immediately after each paired injection
BD Nano™ PRO vs Terumo Nanopass® (Needle Bending)
Time frame: Immediately after injections were completed
BD Nano™ PRO vs Terumo Nanopass® (Leakage)
Time frame: Immediately after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11690726Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
- Background: PubMed 16202529Watson PJ, Latif RK, Rowbotham DJ. Ethnic differences in thermal pain responses: a comparison of South Asian and White British healthy males. Pain. 2005 Nov;118(1-2):194-200. doi: 10.1016/j.pain.2005.08.010. Epub 2005 Oct 3.
- Background: PubMed 17401133Palmer B, Macfarlane G, Afzal C, Esmail A, Silman A, Lunt M. Acculturation and the prevalence of pain amongst South Asian minority ethnic groups in the UK. Rheumatology (Oxford). 2007 Jun;46(6):1009-14. doi: 10.1093/rheumatology/kem037. Epub 2007 Mar 31.
- Background: PubMed 17275416Komiyama O, Kawara M, De Laat A. Ethnic differences regarding tactile and pain thresholds in the trigeminal region. J Pain. 2007 Apr;8(4):363-9. doi: 10.1016/j.jpain.2006.12.002. Epub 2007 Feb 1.
- Background: PubMed 15979019Hobara M. Beliefs about appropriate pain behavior: cross-cultural and sex differences between Japanese and Euro-Americans. Eur J Pain. 2005 Aug;9(4):389-93. doi: 10.1016/j.ejpain.2004.09.006.
- Derived from this study: PubMed 32723109Gibney MA, Fitz-Patrick D, Klonoff DC, Whooley S, Lu B, Yue W, Glezer S. User experiences with second-generation 32-gauge x 4 mm vs. thinner comparator pen needles: prospective randomized trial. Curr Med Res Opin. 2020 Oct;36(10):1591-1600. doi: 10.1080/03007995.2020.1803248. Epub 2020 Aug 18.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terumo Nanopass® 34G pen needle and BD Nano™ PRO 32G pen needle in people with Diabetes, run by Becton, Dickinson and Company at 2 sites 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 8 inclusion and 15 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain) (time frame: Scores were collected immediately after each paired injection). 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 NCT03878745, which also lists 6 linked publications.
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 19 May 2020.