Evaluating the User Performance and Experience of Nucleus... | NCT03267264

NCT03267264

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1	Experimental	Device: BD Nano™ vs Nucleus
Group 2	Experimental	Device: NovoFine® vs Nucleus
Group 3	Experimental	Device: NovoTwist®/NovoFine® Plus vs Nucleus
Group 4	Experimental	Device: Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BD Nano™ vs Nucleus	Device	Subjects will be randomized to Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall User Preference -Combined Groups	This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).	30 Days

Secondary Outcomes

Measure	Description	Time Frame
Overall User Preference - Each Comparator Group	This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (18 - 75 inclusive)
Diagnosed Type 1 or Type 2 diabetes
Every effort will be made to recruit approximately 25% Type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%)
Every effort will be made to recruit a minimum of 30 subjects with Asian ethnicity (of the total population, not of each subgroup). Ideally, 60 Asian subjects are needed for the study
Minimum within the last 4 months experience self-injecting insulin with a pen injector
Minimum within the last 2 months experience self-injecting consistently with one of the following available pen needles OR a subject may be enrolled that is using a 31G/32G pen needle that is not longer than 6mm in length who is willing to transfer to one of the following 32G pen needle with a 14 day wash-in period:
- BD Nano™ 32Gx4mm
- NovoFine® 32Gx6mm
- NovoTwist® 32Gx5mm or
- NovoFine® Plus 32Gx4mm
- Owen Mumford PenTips 32Gx4mm or
- Perrigo / Ypsomed ClickFine 32Gx4mm or
- Other 32G such as UltiMed, MHC, or other private label.
Able and willing to provide informed consent/participant form
Able and willing to complete all study procedures

Exclusion Criteria:

Self-injecting insulin with a pen injector for less than 3 months
Planned changes in insulin regimen (increasing or decreasing number of injections per day).
Positive pregnancy test (urine)
Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted).
History of a bleeding disorder or easy bruising
Blood borne infection(s)
History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema)
Gross skin anomalies and abnormalities (e.g., scars, stretch marks, discolorations, tattoos, superficial masses, acne, inflammation) located at or very close to the injection sites
Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
Use of any prescription analgesic medications within 24 hours of first study injection, and during the study.
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 study
Employed by, or currently serving as a contractor or consultant to BD or any insulin, insulin pen, or insulin pen needle manufacturer

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
East West Medical Research Institute		Honolulu	Hawaii	96814	United States
PMG Research of Raleigh

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Whooley S, Briskin T, Gibney M, Blank L, Berube J, Pflug B. Evaluation the User Performance and Experience of a New Pen Needle with Advanced Hub Face Geometry. Poster presented at: American Association of Diabetes Education Annual Conference; 2018 Aug 17-20; Baltimore, MD.
30809762	Derived	Whooley S, Briskin T, Gibney MA, Blank LR, Berube J, Pflug BK. Evaluating the User Performance and Experience with a Re-Engineered 4 mm x 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles. Diabetes Ther. 2019 Apr;10(2):697-712. doi: 10.1007/s13300-019-0585-7. Epub 2019 Feb 27.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1	BD Nano™ vs Nucleus: Subjects will be randomized to Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 20, 2017	Feb 28, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Group 1	BD Nano™ vs Nucleus: Subjects will be randomized to Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
BG001	Group 2	NovoFine® vs Nucleus: Subjects will be randomized to Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
BG002	Group 3	NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or subject's current pen needle (NovoTwist®/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
BG003	Group 4	Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus: Subjects will be randomized to Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00066 BG00149 BG00268 BG00365 BG004248

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.5± 13.3 BG00156.6± 12.8 BG00255.4± 12.2 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00034 BG00125 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0014 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Overall User Preference -Combined Groups

This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).

Per-protocol population; note that one VAS data point was missing.

Posted

Mean

95% Confidence Interval

30 Days

ID	Title	Description
OG000	Combined Groups	Nucleus vs all groups combined

Units	Counts
Participants	OG000225

Title

Denominators

Categories

Title	Measurements
	OG00017.5(10.3 to 24.7)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						Overall Mean	17.5			2-Sided	95	10.3	24.7					Non-Inferiority	Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.

Secondary

Overall User Preference - Each Comparator Group

This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).

Per-protocol population; note that one VAS data point was missing

Posted

Mean

95% Confidence Interval

30 Days

ID	Title	Description
OG000	Group 1	BD Nano™ vs Nucleus
OG001	Group 2	NovoFine® vs Nucleus
OG002	Group 3	NovoTwist®/NovoFine® Plus vs Nucleus
OG003	Group 4	Other Commercially Available Pen Needles

Secondary

User Experience - All Study Groups Combined

This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.

Per-protocol population

Posted

Mean

95% Confidence Interval

30 Days

ID	Title	Description
OG000	All Groups Combined	Resutls from comparator pen needle groups combined and compared to NUCLEUS

Units	Counts
Participants	OG000

Secondary

User Experience - Each Individual Study Group

This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current 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 for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.

Per-protocol population

Posted

Mean

95% Confidence Interval

30 Days

ID	Title	Description
OG000	Group 1	BD Nano™ vs Nucleus
OG001	Group 2	NovoFine® vs Nucleus
OG002	Group 3	NovoTwist®/NovoFine® Plus vs Nucleus
OG003	Group 4	Other Commercially Available Pen Needles

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nucleus	This arm contains every subject in the study. Because every subject regardless of group recieved Nucleus	241	1	241	50	241
EG001	BD Nano	This arm contains only those subjects that recieve BD Nano, included in results section described in group 1.	65	0	65	5	65
EG002	NovoFine®	This arm contains only those subjects that recieved NovoFine®, included in results section described in group 2.	49	1	49	4	49
EG003	NovoTwist®/NovoFine®	This arm contains only those subjects that recieved NovoTwist®/NovoFine®, included in results section described in group 3.	66	0	66	4	66
EG004	Other Commercially Available Pen Needles (Unifine® Pentips®/M	This arm contains only those subjects that recieved Other Commercial Pen Needles, included in results section described in group 4.	61	1	61	5	61

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Broken Right Ankle	Surgical and medical procedures	Systematic Assessment	Subject broke their ankle	EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG0030 events0 affected66 at risk
Infection of L Hand Laceration	Infections and infestations	Systematic Assessment		EG0000 events0 affected241 at risk EG0010 events0 affected65 at risk EG0021 events1 affected49 at risk EG003
Influenza	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Bleeding	Injury, poisoning and procedural complications	Systematic Assessment	Experience exceeds that normally associated with the procedure, as judged by the Subject	EG00021 events21 affected241 at risk EG0014 events4 affected65 at risk EG0021 events1 affected49 at risk EG0032 events2 affected66 at risk
Bruising	Injury, poisoning and procedural complications	Systematic Assessment	Experience exceeds that normally associated with the procedure, as judged by the Subject	EG00014 events14 affected241 at risk EG0011 events1 affected65 at risk EG0020 events0 affected49 at risk EG003
Swelling/Pain at injection site	Injury, poisoning and procedural complications	Systematic Assessment	Experience exceeds that normally associated with the procedure, as judged by the Subject	EG00010 events10 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003
Hypoglycemia	Endocrine disorders	Systematic Assessment		EG0000 events0 affected241 at risk EG0010 events0 affected65 at risk EG0021 events1 affected49 at risk EG003
Abcess under chin	Infections and infestations	Systematic Assessment		EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003
Common Cold	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003
Diarrhea	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected241 at risk EG0010 events0 affected65 at risk EG0021 events1 affected49 at risk EG003
L hand Laceration	Surgical and medical procedures	Systematic Assessment		EG0000 events0 affected241 at risk EG0010 events0 affected65 at risk EG0021 events1 affected49 at risk EG003
Respiratory Illness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003
Stomach Ulcer	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003
Worsening of Type 2 Diabetes	Endocrine disorders	Systematic Assessment		EG0001 events1 affected241 at risk EG0010 events0 affected65 at risk EG0020 events0 affected49 at risk EG003

ID	Term
D003920	Diabetes Mellitus

Units	Counts
Participants	OG00060 OG00142 OG00264 OG00359

EG0040 events0 affected61 at risk

EG0041 events1 affected61 at risk

EG0042 events2 affected61 at risk

EG0041 events1 affected61 at risk

EG0040 events0 affected61 at risk

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases