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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BD Nano™ PRO 32G pen needle | Experimental | Participants are to perform 6 pairs of injections. |
|
| Terumo Nanopass® 34G pen needle | Active Comparator | Participants are to perform 6 pairs of injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terumo Nanopass® 34G pen needle | Device | Insulin pen needle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Scores were collected immediately after each paired injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mills-Peninsula Medical Center Dorothy L. and James E Frank Diabetes Research Institute | San Mateo | California | 94401 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11690726 | Background | 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. | |
| 16202529 | Background | Watson 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. |
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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 Terumo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 Terumo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Per protocol population | Posted | Mean | 95% Confidence Interval | mm | Scores were collected immediately after each paired injection | paired injections | paired injections |
For each subject, adverse event data was collected at one visit.
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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 | Subjects are to perform 6 pairs of injections. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Gibney | Becton Dickinson | 201-847-6170 | Michael.gibney@bd.com |
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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 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | Aug 1, 2019 | SAP_001.pdf |
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| 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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BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
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Participants will not see any labeling for the pen needles used for injections
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| BD Nano™ PRO 32G pen needle | Device | Insulin pen needle |
|
| 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. | 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. | Immediately after injection |
| Immediately after injections were completed |
| 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. | Immediately after injections were completed |
| East West Medical Research Institute |
| Honolulu |
| Hawaii |
| 96814 |
| United States |
| 17401133 | Background | Palmer 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. |
| 17275416 | Background | Komiyama 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. |
| 15979019 | Background | Hobara 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. |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Are you of Japanese descent | Count of Participants | Participants |
|
| Born in Japan | Count of Participants | Participants |
|
| At Least one(1) Parent born in Japan | Count of Participants | Participants |
|
| At Least one(1) Grandparent born in Japan | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | All Study Participants | Subjects are to perform 6 pairs of injections. Each Pair consists of BD Nano™ PRO pen needle vs Terumo |
|
|
| 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. | Per-protocol population | Posted | Mean | 95% Confidence Interval | score on a scale | Scores were collected immediately after each paired injection | paired injections | paired injections |
|
|
|
|
| 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. | per protocol population | Posted | Number | 95% Confidence Interval | percentage of needles with bending | Immediately after injections were completed | pen needles | pen needles |
|
|
|
|
| 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. | per protocol population | Posted | Number | 95% Confidence Interval | percentage of participants with leakage | Immediately after injection | Pen Needles | Pen Needles |
|
|
|
|
| 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. | Per Protocol population | Posted | Mean | Standard Deviation | seconds | Immediately after injections were completed | pen needles | pen needles |
|
|
|
|
| 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. | Per-protocol population | Posted | Number | 95% Confidence Interval | percentage of needles with breaking | Immediately after injections were completed | pen needles | pen needles |
|
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| 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. | Each subject was asked to fill out a 4 question survey on the importance of Injection Pain, Thumb pressure, Leakage and Needle Bending | Posted | Count of Participants | Participants | Immediately after injections were completed |
|
|
|
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Terumo Nanopass | Subjects are to perform 6 pairs of injections. | 0 | 55 | 0 | 55 | 0 | 55 |
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| Terumo |
|
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| Somewhat Disagree |
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| Disagree |
|
| Thumb pressure needed affects my level of satisfac |
|
| Post injection leakage increases level of concern |
|
| A bent needle increases my level of concern |
|