User experiences with second-generation 32-gauge × 4 mm vs. thinner comparator pen needles: prospective randomized trial

Gibney, Michael A.; Fitzpatrick, David; Klonoff, David C.; Whooley, Shahista; Lu, Betty; Wen, Yeong-Ray; Glezer, Stanislav

doi:10.1080/03007995.2020.1803248

Cited by 3 publications

(1 citation statement)

References 31 publications

(42 reference statements)

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“…In a subsequent single-visit study, PROs were similarly positive, with less injection pain and less perceived dose delivery force reported for the extra-thin wall, 5-bevel 32G x 4 mm PN as compared with 4 thinner commercially available PNs. 49…”

Section: Needle Length and Gaugementioning

confidence: 99%

Needle Technology for Insulin Administration: A Century of Innovation

Heinemann¹,

Nguyen²,

Bailey

et al. 2021

J Diabetes Sci Technol

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Innovations in syringe and pen needle (PN) technology over the last 100 years have led to important advances in insulin delivery for people with diabetes, paralleling the strides made in developing recombinant DNA human insulin and insulin analogs with varying onset and duration of action. In this review, the history of advances in insulin delivery is described, focusing on progress in syringe, needle, and PN technologies. The early glass and metal syringes that required sterilization by boiling have been replaced by disposable, single-use syringes or pens with clear labeling for precise insulin dosing. The early needles ranging in length from 19 to 26 mm that required manual sharpening against a whetstone have been replaced by syringe needles of 6 mm and PNs of 4 mm in length as slender as 34 gauge. Imaging studies using ultrasound and computed tomography measured the thickness of skin and subcutaneous tissue layers to show feasibility of targeted insulin administration with shorter needles. These developments, coupled with innovations in needle/PN wall and tip structure, have led to improved injection experience for people with diabetes. It is also important to acknowledge the role of injection technique education, together with these advances in injection technology, for improving clinical outcomes and patient satisfaction. With continued projected growth of diabetes prevalence, particularly in developing countries where expensive and complex insulin delivery systems may not be practical, insulin syringes and pens will continue to serve as reliable and cost-effective means of insulin delivery for people with diabetes.

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Section: Needle Length and Gaugementioning

confidence: 99%

Needle Technology for Insulin Administration: A Century of Innovation

Heinemann¹,

Nguyen²,

Bailey

et al. 2021

J Diabetes Sci Technol

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Optimising Insulin Injection Techniques to Improve Diabetes Outcomes

Kalra,

Pathan,

Kshanti

et al. 2023

Diabetes Ther

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Use of a Diabetes Self-Management App in Combination with a 4mm Pen Needle and its Impact on Glycemic Variability and Patient Reported Outcomes in People with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (Preprint)

Mahoney¹,

Glezer²,

Baccari³

et al. 2021

Preprint

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BACKGROUND Studies of mobile diabetes applications (apps) have demonstrated improvements in glycemia, and patient reported outcomes (PROs). In addition, the potential for reduced glycemic variability has been realized through the use of shorter pen needles (PN) and adoption of proper injection techniques. OBJECTIVE To determine the impact of using a diabetes mobile app plus a novel 4 mm pen needle (PN) on patient reported outcomes (PROs) and glycemic outcomes in people with T2DM using multiple daily injections (MDI) of insulin. METHODS This was a prospective, parallel group, randomized controlled trial. People with T2DM administering MDI with baseline hemoglobin A1c (HbA1c) concentrations of 8% - 11% were enrolled. The study lasted 10 weeks with PRO’s answered Pre/Post. Subjects wore a blinded flash glucose monitor (fGM) the first two and last two weeks. Following fGM use, subjects were randomized 1:1 to either Intervention (BD Diabetes Care (DC) App + BD Nano 2nd Gen PN) or Control for 8 weeks. Controls used their current PN and did not use diabetes apps. At study end, the Intervention group answered a survey on satisfaction with the app and PN. RESULTS Fifty-eight subjects were randomized and 57 completed the study (Intervention n=27, Control n=30). Mean (SD) age of subjects was 53.8 ± 10.3 (mean ± SD) years and duration of insulin therapy was 9.5 ± 6.5 years. At study end, there were no significant differences in PROs between groups, except an improvement in medication adherence (ARMS-D) in Controls, leading to significant between-group differences (P = 0.04). From fGM data, there were no significant differences in most glycemic measures between groups except for a trend for improved glycemic variability as measured by the mean amplitude of glycemic excursions (MAGE) in the Intervention group (P = 0.06). Controls spent significantly less time in hypoglycemia but had a 2 to 3-fold higher incidence at baseline. Intervention subjects had numerical improvements in several glycemic parameters whereas Controls had numerical decrements in these values over the study. In general, Intervention subjects reported satisfaction with the app and PN. CONCLUSIONS This is the first BD DC App study, in combination with BD Nano 2nd Gen PN, to assess glycemic outcomes. The Intervention showed a trend for improved glycemic variability and numerical improvements in several glycemic measures over the course of the study. This combination intervention shows promising results for reduced glycemic variability and the potential to positively impact patients’ diabetes self-management. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04090242

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User experiences with second-generation 32-gauge × 4 mm vs. thinner comparator pen needles: prospective randomized trial

Cited by 3 publications

References 31 publications

Needle Technology for Insulin Administration: A Century of Innovation

Needle Technology for Insulin Administration: A Century of Innovation

Optimising Insulin Injection Techniques to Improve Diabetes Outcomes

Use of a Diabetes Self-Management App in Combination with a 4mm Pen Needle and its Impact on Glycemic Variability and Patient Reported Outcomes in People with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (Preprint)

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