Diabetes
Conditions
Brief summary
This is a subject partially blinded, block randomized, prospective, single-visit, multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. three (3) thinner commercially available comparator pen needles (Artsana Insupen Extr3me 33G, Artsana Insupen Extr3me 34G and the Simple Diagnostics Comfort EZ™ 33G Pen Needles). The study will include up to 146 study subjects having Type 1 or Type 2 diabetes.
Detailed description
The study will consist of one 60 to 120 minute 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. The pen needle outer cover and inner shield will be removed prior to subject use so that they will not be able to identify which device they are using. 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 comparator pen needle. Within the 12 injections, each comparator will be injected twice, therefore each subject will experience 2 of each of the following pairs: BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G Each Subject will evaluate pain after completion of each pair of injections using a 15 cm relative Visual Analog Scale (VAS).
Interventions
DEVICEBD Nano™ PRO
Insulin Pen needle
DEVICE33G Artsana Insupen Extr3me
Insulin Pen Needle
DEVICE34G Artsana Insupen Extr3me
Insulin Pen Needle
DEVICESimple Diagnostics Comfort EZ™
Insulin Pen Needle
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will not see any labeling for the Pen Needles used for the injections
Intervention model description
BD Nano (Test Device) will be compared to other currently marketed devices (controls) through a series of abdominal saline injections
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults 18 to 75 years of age (inclusive) 2. Diagnosed with Type 1 or Type 2 diabetes 3. Self-injecting using an injection pen for ≥3 months with any pen needle 4. Injecting a minimum of ≥10 units of insulin and/or Victoza at least once per day 5. Able to demonstrate proficiency using an injection pen into an injection model 6. Able and willing to provide informed consent 7. Able and willing to complete all study procedures
Exclusion criteria
* a. Not self-injecting (example, injections completed by a family member) b. Self-injecting with a pen injector for less than 3 months c. Unwilling to inject into abdomen d. Unwilling to have hair at the injection area reduced with an electric razor if it is determined the hair will interfere with leakage evaluation e. 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. f. Pregnant (self-attestation) g. Currently taking anti-platelet or anticoagulant therapy (up to 162 mg per day of aspirin is permitted). h. History of a bleeding disorder i. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema) j. Gross skin anomalies and abnormalities located at or very close to the injection sites that would significantly limit available injection space. k. History of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections l. Use of any analgesic medications (prescription or OTC) within 24 hours of first study injection, and during the study (up to 162 mg per day of aspirin is permitted). m. 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 n. Currently participating in another pen needle study o. 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 |
|---|---|---|
| Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators | Scores were collected immediately after each paired injection | Injection pain as measured by a relative visual analog scale. This endpoint analyzes data for individual groups. 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 (308 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 |
|---|---|---|
| Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles | Scores were collected immediately after each paired injection | 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. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of bent needle events in the BD Nano™ PRO and each competitor were compared and the mean difference reported with a 95% confidence interval. |
| Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage) | Leakage was measured directly after each 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 incidence of leakage (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval. A positive score indicates fewer leakage events with the BD Nano™ PRO and a negative score indicates fewer leakage events with the competitor. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of needle leakage in the BD Nano™ PRO and each comparator were compared and the mean difference reported with a 95% confidence interval. |
| Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force) | Immediately after injection Pair | 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 the comparator. Scores from each of the paired injections were pooled and a mean was calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) | Time of injection | Time from when subject when is depressed and time when removed from body. |
Countries
United States
Participant flow
Pre-assignment details
Each subject received more than one treatment
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 Artsana Insupen Extr3me 4mm x 33G or Artsana Insupen Extr3me 3.5mm x 34G or Simple Diagnostics Comfort EZ™ 4mm x 33G | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Improper consent documentation | 1 |
| Overall Study | Protocol defined | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 23 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 12 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 88 Participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 157 | 0 / 157 | 0 / 157 |
| other Total, other adverse events | 0 / 157 | 0 / 157 | 0 / 157 | 0 / 157 |
| serious Total, serious adverse events | 0 / 157 | 0 / 157 | 0 / 157 | 0 / 157 |
Outcome results
Primary
Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators
Injection pain as measured by a relative visual analog scale. This endpoint analyzes data for individual groups. 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 (308 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) |
|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators | 17.55 mm |
| BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me | Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators | 17.39 mm |
| BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ | Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators | 9.13 mm |
Secondary
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (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 the comparator. Scores from each of the paired injections were pooled and a mean was calculated.
Time frame: Immediately after injection Pair
Population: Subjects protocol population with non-missing data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force) | 0.8 Score on a scale |
| BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force) | 1.0 Score on a scale |
| BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force) | 0.3 Score on a scale |
95% CI: [0.62, 0.98]
95% CI: [0.8, 1.16]
95% CI: [0.13, 0.49]
Secondary
Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles
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. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of bent needle events in the BD Nano™ PRO and each competitor were compared and the mean difference reported with a 95% confidence interval.
Time frame: Scores were collected immediately after each paired injection
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles | -0.39 Difference in incidence |
| BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me | Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles | 0.13 Difference in incidence |
| BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ | Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles | 0.42 Difference in incidence |
p-value: 0.59195% CI: [-1.82, 1.04]Fisher Exact
p-value: 0.93195% CI: [-2.8, 3.06]Fisher Exact
p-value: 0.72395% CI: [-1.91, 2.75]Fisher Exact
Secondary
Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (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 incidence of leakage (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval. A positive score indicates fewer leakage events with the BD Nano™ PRO and a negative score indicates fewer leakage events with the competitor. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of needle leakage in the BD Nano™ PRO and each comparator were compared and the mean difference reported with a 95% confidence interval.
Time frame: Leakage was measured directly after each injection
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage) | -5.70 Difference in incidence |
| BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me | Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage) | -14.09 Difference in incidence |
| BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ | Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage) | -0.20 Difference in incidence |
p-value: <0.00195% CI: [-9, -3.5]Fisher Exact
p-value: 0.02695% CI: [-26.49, -1.69]Fisher Exact
p-value: 0.64495% CI: [-1.9, 0.6]Fisher Exact
Post Hoc
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Needle Breaking)
A needle was considered broken if the patient end and canula was separated into 2 pieces. The number and proportion of needle breaking occurrence for each pen needle type were summarized. The incidence of broken needle events for the BD Nano PRO was compared to each of the 3 comparator products and the mean difference reported with a 95% confidence interval.
Time frame: Immediately after injection
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Needle Breaking) | 0 Difference in incidence |
| BD Nano™ PRO Pen Needle vs 33G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Needle Breaking) | 0 Difference in incidence |
| BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Needle Breaking) | 0 Difference in incidence |
95% CI: [-0.4, 1.2]
95% CI: [-0.4, 1.2]
95% CI: [-0.4, 1.2]
Other Pre-specified
Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time)
Time from when subject when is depressed and time when removed from body.
Time frame: Time of injection
Population: Per Protocol Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) | BD NANO | 8.39 seconds | Standard Deviation 5.26 |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) | Artsana 33G | 10.98 seconds | Standard Deviation 2.64 |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) | Arstana 34G | 9.93 seconds | Standard Deviation 5.16 |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time) | Comfort EZ 33G | 8.63 seconds | Standard Deviation 5.3 |
Comparison: BD Nano Pro vs Artsana 34Gp-value: <0.001Mixed Models Analysis
Comparison: BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.p-value: 0.104Mixed Models Analysis
Comparison: BD NANO vs Comfort EZ 33Gp-value: 0.003Mixed Models Analysis
Post Hoc
Subject Satisfaction Survey
Each subject was given a non-comparative 4-question survey on Pen needle characteristics.
Time frame: At the end of study
Population: Each subject was provided a 4 question survey of their general experience with pen needles. The questions were based on a a 5 point type of Likert scale.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Injection pain affects my level of satisfaction | Agree | 56 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Injection pain affects my level of satisfaction | Somewhat Agree | 46 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Injection pain affects my level of satisfaction | Neutral | 27 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Injection pain affects my level of satisfaction | Somewhat disagree | 8 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Injection pain affects my level of satisfaction | Disagree | 17 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Thumb pressure affects my level of satisfaction | Agree | 54 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Thumb pressure affects my level of satisfaction | Somewhat Agree | 51 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Thumb pressure affects my level of satisfaction | Neutral | 26 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Thumb pressure affects my level of satisfaction | Somewhat disagree | 9 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Thumb pressure affects my level of satisfaction | Disagree | 14 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Post injection leakage affects my level of concern | Agree | 76 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Post injection leakage affects my level of concern | Somewhat Agree | 31 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Post injection leakage affects my level of concern | Neutral | 23 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Post injection leakage affects my level of concern | Somewhat disagree | 8 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | Post injection leakage affects my level of concern | Disagree | 16 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | A bend needle increases my level of concern | Agree | 100 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | A bend needle increases my level of concern | Somewhat Agree | 28 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | A bend needle increases my level of concern | Neutral | 13 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | A bend needle increases my level of concern | Somewhat disagree | 2 Participants |
| BD Nano™ PRO Pen Needle vs 34G Artsana Insupen Extr3me | Subject Satisfaction Survey | A bend needle increases my level of concern | Disagree | 11 Participants |