Diabetes
Conditions
Brief 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. 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.
Interventions
DEVICETerumo Nanopass® 34G pen needle
Insulin pen needle
DEVICEBD Nano™ PRO 32G pen needle
Insulin pen needle
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Participants will not see any labeling for the pen needles used for injections
Intervention model description
BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Self-attesting Japanese American adults 18 to 75 years of age (inclusive). 2. Self-attest to Japanese descent. 3. Diagnosed with Type 1 or Type 2 diabetes. 4. Self-injecting using an injection pen for ≥3 months with any pen needle. 5. Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day. 6. Able to demonstrate proficiency using an injection pen into an injection model. 7. Able and willing to provide informed consent. 8. Able and willing to complete all study procedures.
Exclusion criteria
1. Not self-injecting (for example injections completed by a family member). 2. Self-injecting with a pen injector for less than 3 months. 3. Unwilling to inject into abdomen. 4. Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation. 5. 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. 6. Pregnant (self-attestation). 7. Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin is permitted). 8. History of a bleeding disorder. 9. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema). 10. Gross skin anomalies and abnormalities located at or very close to the injection sites that would significantly limit available injection space. 11. History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections. 12. 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). 13. 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. 14. Currently participating in another pen needle study. 15. Employed by, or currently serving as a contractor or consultant to BD or any diabetes injectable medication, injection pen, or pen needle manufacturer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BD Nano™ PRO vs Terumo Nanopass® (Force) | Scores were collected immediately after each paired injection | 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. |
| BD Nano™ PRO vs Terumo Nanopass® (Needle Bending) | Immediately after injections were completed | 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. |
| BD Nano™ PRO vs Terumo Nanopass® (Leakage) | Immediately after injection | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time) | Immediately after injections were completed | Time from when injection button fully depressed to when pen needle removed from body. Mean total injection time was calculated for both the BD Nano™ PRO and the Terumo Nanopass®. Scores from each injection (330 for each needle type) were pooled and a mean was calculated. The total injection time for the BD Nano™ PRO and Terumo Nanopass® were compared and the mean difference reported with a 95% confidence interval. |
| Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking) | Immediately after injections were completed | Needle breakage was defined as the patient-end metal cannula being separated into two pieces. The percentage of of breaking events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 9.8 |
| Are you of Japanese descent No | 0 Participants |
| Are you of Japanese descent Yes | 55 Participants |
| At Least one(1) Grandparent born in Japan No | 4 Participants |
| At Least one(1) Grandparent born in Japan Yes | 51 Participants |
| At Least one(1) Parent born in Japan No | 43 Participants |
| At Least one(1) Parent born in Japan Yes | 12 Participants |
| Born in Japan No | 46 Participants |
| Born in Japan Yes | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 55 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
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.
Time frame: Scores were collected immediately after each paired injection
Population: Per protocol population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Study Participants | BD Nano™ PRO Pen Needle Compared to Terumo Nanopass® (Injection Pain) | 7.30 mm |
Secondary
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.
Time frame: Scores were collected immediately after each paired injection
Population: Per-protocol population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Study Participants | BD Nano™ PRO vs Terumo Nanopass® (Force) | 0.210 score on a scale |
95% CI: [0.07, 0.35]
Secondary
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.
Time frame: Immediately after injection
Population: per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants | BD Nano™ PRO vs Terumo Nanopass® (Leakage) | 0.3 percentage of participants with leakage |
| Terumo Nanopass | BD Nano™ PRO vs Terumo Nanopass® (Leakage) | 1.8 percentage of participants with leakage |
95% CI: [-3.6, 0.1]
Secondary
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.
Time frame: Immediately after injections were completed
Population: per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants | BD Nano™ PRO vs Terumo Nanopass® (Needle Bending) | 0.6 percentage of needles with bending |
| Terumo Nanopass | BD Nano™ PRO vs Terumo Nanopass® (Needle Bending) | 0.6 percentage of needles with bending |
95% CI: [-1.6, 1.6]
Other Pre-specified
Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking)
Needle breakage was defined as the patient-end metal cannula being separated into two pieces. The percentage of of breaking events (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval.
Time frame: Immediately after injections were completed
Population: Per-protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Study Participants | Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking) | 0 percentage of needles with breaking |
| Terumo Nanopass | Compare BD Nano™ PRO vs Terumo Nanopass® (Needle Breaking) | 0 percentage of needles with breaking |
95% CI: [-1.2, 1.2]
Other Pre-specified
Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time)
Time from when injection button fully depressed to when pen needle removed from body. Mean total injection time was calculated for both the BD Nano™ PRO and the Terumo Nanopass®. Scores from each injection (330 for each needle type) were pooled and a mean was calculated. The total injection time for the BD Nano™ PRO and Terumo Nanopass® were compared and the mean difference reported with a 95% confidence interval.
Time frame: Immediately after injections were completed
Population: Per Protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time) | BD NANO | 7.55 seconds | Standard Deviation 4.75 |
| All Study Participants | Compare BD Nano™ PRO vs Terumo Nanopass® (Total Injection Time) | Terumo | 7.80 seconds | Standard Deviation 4.62 |
p-value: <0.001Mixed Models Analysis
Post Hoc
Subject Satisfaction Survey
Each subject was asked to fill out a 4 question survey on the general importance of Injection Pain, Thumb pressure, Leakage and Needle Bending, each question was tabulated. Each participant answered 1 survey about their general preferences and opinions, not regarding either product used in the study.
Time frame: Immediately after injections were completed
Population: Each subject was asked to fill out a 4 question survey on the importance of Injection Pain, Thumb pressure, Leakage and Needle Bending
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Study Participants | Subject Satisfaction Survey | Injection Pain affects my level of satisfaction | Disagree | 4 Participants |
| All Study Participants | Subject Satisfaction Survey | A bent needle increases my level of concern | Agree | 23 Participants |
| All Study Participants | Subject Satisfaction Survey | Injection Pain affects my level of satisfaction | Agree | 16 Participants |
| All Study Participants | Subject Satisfaction Survey | Injection Pain affects my level of satisfaction | Somewhat Agree | 16 Participants |
| All Study Participants | Subject Satisfaction Survey | Injection Pain affects my level of satisfaction | Neutral | 16 Participants |
| All Study Participants | Subject Satisfaction Survey | Injection Pain affects my level of satisfaction | Somewhat Disagree | 3 Participants |
| All Study Participants | Subject Satisfaction Survey | Thumb pressure needed affects my level of satisfac | Agree | 10 Participants |
| All Study Participants | Subject Satisfaction Survey | Thumb pressure needed affects my level of satisfac | Somewhat Agree | 21 Participants |
| All Study Participants | Subject Satisfaction Survey | Thumb pressure needed affects my level of satisfac | Neutral | 14 Participants |
| All Study Participants | Subject Satisfaction Survey | Thumb pressure needed affects my level of satisfac | Somewhat Disagree | 7 Participants |
| All Study Participants | Subject Satisfaction Survey | Thumb pressure needed affects my level of satisfac | Disagree | 3 Participants |
| All Study Participants | Subject Satisfaction Survey | Post injection leakage increases level of concern | Agree | 18 Participants |
| All Study Participants | Subject Satisfaction Survey | Post injection leakage increases level of concern | Somewhat Agree | 16 Participants |
| All Study Participants | Subject Satisfaction Survey | Post injection leakage increases level of concern | Neutral | 16 Participants |
| All Study Participants | Subject Satisfaction Survey | Post injection leakage increases level of concern | Somewhat Disagree | 4 Participants |
| All Study Participants | Subject Satisfaction Survey | Post injection leakage increases level of concern | Disagree | 1 Participants |
| All Study Participants | Subject Satisfaction Survey | A bent needle increases my level of concern | Somewhat Agree | 13 Participants |
| All Study Participants | Subject Satisfaction Survey | A bent needle increases my level of concern | Neutral | 17 Participants |
| All Study Participants | Subject Satisfaction Survey | A bent needle increases my level of concern | Somewhat Disagree | 1 Participants |
| All Study Participants | Subject Satisfaction Survey | A bent needle increases my level of concern | Disagree | 1 Participants |