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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BD Nano™ PRO pen needle vs 33G Artsana Insupen Extr3me | Experimental | Subjects are to perform 2 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 |
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| BD Nano™ PRO pen needle vs 34G Artsana Insupen Extr3me | Experimental | Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs Artsana Insupen Extr3me 3.5mm x 34G x 2 |
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| BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ | Experimental | Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Nano™ PRO | Device | Insulin Pen needle |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Scores were collected immediately after each paired injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of injection |
Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East West Medical Research Institute | Honolulu | Hawaii | 96814 | United States | ||
| TKL Research Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32723109 | Derived | Gibney 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. |
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Each subject received more than one treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2019 | Aug 1, 2019 |
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BD Nano (Test Device) will be compared to other currently marketed devices (controls) through a series of abdominal saline injections
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Participants will not see any labeling for the Pen Needles used for the injections
| 33G Artsana Insupen Extr3me | Device | Insulin Pen Needle |
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| 34G Artsana Insupen Extr3me | Device | Insulin Pen Needle |
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| Simple Diagnostics Comfort EZ™ | Device | Insulin Pen Needle |
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| Scores were collected immediately after each paired injection |
| 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. | Leakage was measured directly after each injection |
| 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. | Immediately after injection Pair |
| Fair Lawn |
| New Jersey |
| 07410 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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the subject that withdrew was not counted in population because the subject withdrew before enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per-protocol population | Posted | Mean | 95% Confidence Interval | mm | Scores were collected immediately after each paired injection | paired injections | paired injections |
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| 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. | Per protocol population | Posted | Number | 95% Confidence Interval | Difference in incidence | Scores were collected immediately after each paired injection | paired injections | paired injections |
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| 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. | Per protocol population | Posted | Number | 95% Confidence Interval | Difference in incidence | Leakage was measured directly after each injection | Pen Needles | Pen Needles |
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| 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. | Subjects protocol population with non-missing data | Posted | Mean | 95% Confidence Interval | Score on a scale | Immediately after injection Pair | paired injections | paired injections |
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| 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. | Per Protocol Population | Posted | Mean | Standard Deviation | seconds | Time of injection | Pen needles | Pen needles |
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| 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | Difference in incidence | Immediately after injection | paired injections | paired injections |
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| Post-Hoc | Subject Satisfaction Survey | Each subject was given a non-comparative 4-question survey on Pen needle characteristics. | 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. | Posted | Count of Participants | Participants | At the end of study |
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one day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BD Nano™ PRO Pen Needle | Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product. | 0 | 157 | 0 | 157 | 0 | 157 |
| EG001 | 34G Artsana Insupen Extr3me | Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product. | 0 | 157 | 0 | 157 | 0 | 157 |
| EG002 | 33G Artsana Insupen Extr3me | Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product. | 0 | 157 | 0 | 157 | 0 | 157 |
| EG003 | Simple Diagnostics Comfort EZ™ | Subjects are to perform 2 pairs of injections. Each pair consists of Nano™ PRO pen needle vs a competitor product. | 0 | 157 | 0 | 157 | 0 | 157 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Gibney | Becton Dickinson | 201-847-6170 | michael.gibney@bd.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2019 | Aug 1, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle |
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| OG002 | BD Nano™ PRO Pen Needle vs Simple Diagnostics Comfort EZ™ | Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2 BD Nano™ PRO: Insulin Pen needle Simple Diagnostics Comfort EZ™: Insulin Pen Needle |
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Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2
BD Nano™ PRO: Insulin Pen needle
Simple Diagnostics Comfort EZ™: Insulin Pen Needle
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Subjects are to perform 2 pairs of injections. Each pair consists of BD Nano™ PRO pen needle vs Simple Diagnostics Comfort EZ™ 4mm x 33G x 2
BD Nano™ PRO: Insulin Pen needle
Simple Diagnostics Comfort EZ™: Insulin Pen Needle
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| Somewhat disagree |
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| Disagree |
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| Somewhat disagree |
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| Disagree |
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| Somewhat disagree |
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| Disagree |
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