Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes

Præstmark, Kezia Ann; Jensen, Morten Lind; Madsen, Nils Berg; Kildegaard, Jonas; Stallknecht, Bente

doi:10.1136/bmjdrc-2016-000266

Cited by 26 publications

(17 citation statements)

References 25 publications

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“…Stainless steel BD Ultra-Fine Pen needles were purchased from Becton Dickinson. The needle small diameter and five grind bevel shape are specifically engineered to limit pain and penetration force and coated with a silicone lubricant to minimize tissue trauma upon insertion 38 . Needle cap trimming was performed with a Model 6.75 60 W CO 2 raster/vector laser system (Universal Laser Systems, Scottsdale, AZ) and position of cut was controlled through the stages and software.…”

Section: Methodsmentioning

confidence: 99%

Extraction and biomolecular analysis of dermal interstitial fluid collected with hollow microneedles

Miller¹,

Taylor²,

Tran³

et al. 2018

Commun Biol

181

175

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Dermal interstitial fluid (ISF) is an underutilized information-rich biofluid potentially useful in health status monitoring applications whose contents remain challenging to characterize. Here, we present a facile microneedle approach for dermal ISF extraction with minimal pain and no blistering for human subjects and rats. Extracted ISF volumes were sufficient for determining transcriptome, and proteome signatures. We noted similar profiles in ISF, serum, and plasma samples, suggesting that ISF can be a proxy for direct blood sampling. Dynamic changes in RNA-seq were recorded in ISF from induced hypoxia conditions. Finally, we report the first isolation and characterization, to our knowledge, of exosomes from dermal ISF. The ISF exosome concentration is 12–13 times more enriched when compared to plasma and serum and represents a previously unexplored biofluid for exosome isolation. This minimally invasive extraction approach can enable mechanistic studies of ISF and demonstrates the potential of ISF for real-time health monitoring applications.

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Section: Methodsmentioning

confidence: 99%

Extraction and biomolecular analysis of dermal interstitial fluid collected with hollow microneedles

Miller¹,

Taylor²,

Tran³

et al. 2018

Commun Biol

181

175

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show abstract

“…As needles become narrower, more force or time is needed to deliver similar doses. The amount of force required to deliver doses may also be associated with injection pain 28 . With insulin pens, the amount of force applied to the thumb button to deliver the dose may also be transferred to the needle insertion into the body.…”

Section: Discussionmentioning

confidence: 99%

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

Gibney

Fitzpatrick

Klonoff

et al. 2020

Current Medical Research and Opinion

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Objective: Two similarly designed studies compared user experiences with a second-generation extrathin-wall, 5-bevel 32 G Â 4 mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs. Methods: Adults (18-75 years old) with type 1 or type 2 diabetes and !3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies. The investigational 32 G PN was compared with three 33-34 G Â 3.5-4 mm PNs in Study 1 and one 34 G Â 4 mm PN in Study 2. Participants completed 12 abdominal injections of 0.3 mL sterile saline using insulin pens in 6 pairs, each comprising one investigational 32 G PN and one comparator PN in random order. After each injection pair, participants compared injection pain via relative 150 mm visual analog scale (VAS) and perceived dose delivery force via relative 5 point Likert scale. Adjusted models tested injection pain scores (primary endpoint) for noninferiority and, if met, then for superiority. ClinicalTrials.gov identifiers: NCT03878758 and NCT03878745. Results: The investigational 32 G PN met noninferiority as well as superiority criteria for less injection pain vs. each comparator (p < .01), with adjusted mean relative VAS scores 9.1-17.6 in Study 1 (n ¼ 154) and 7.3 in Study 2 (n ¼ 55). The investigational 32 G PN was also superior vs. each comparator PN in requiring less relative perceived force to deliver the dose (p < .01). Conclusions: The investigational 32 G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.

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“…Data from the literature suggest that different types of needles, with different diameters, lengths, and geometry, might affect patient preference, adherence to medication, pain perception, and glycemic control [13,[15][16][17][18][19][20]. Despite the advances in needle technology, there has been some hesitance among diabetes healthcare professionals and patients alike regarding the use of shorter needles.…”

Section: Introductionmentioning

confidence: 99%

Evaluating the User Preference and Level of Insulin Self-Administration Adherence in Young Patients With Type 1 Diabetes: Experience With Two Insulin Pen Needle Lengths

Hayek¹,

Dawish²

2020

Cureus

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Background Selecting the appropriate insulin pen needle is important to reduce pain and injection-related adverse events like insulin leakage. It also helps to improve medication adherence and glycemic control in patients with type 1 diabetes mellitus (T1DM). Objective This study aimed to compare the 6-mm and 8-mm 32.5-gauge insulin pen needles in terms of glycemic control, pain score, user preference, medication adherence, and injection adverse events in patients with T1DM. Methods We conducted a prospective cohort study of 62 patients with T1DM. All patients constituted an experimental group initially and then changed the length of the needle to be part of a selfcontrol group. The glycemic control, visual analog scale (VAS) pain score, Morisky Medication Adherence Scale (MMAS) score, needle attribute score, and injection-related adverse events were measured for all patients with both lengths of needles. Patients were assessed at the baseline visit and followed up for three months. Statistical comparisons were done by the chisquared test, paired t-test, and paired Wilcoxon test when appropriate with a two-tailed alpha level below 0.05 indicating statistical significance. Results With the NanoPass® 32.5-gauge, 6-mm needle (Terumo Corp., Tokyo, Japan), patients had significantly lower glycated hemoglobin (HbA1c) compared to 8-mm needles (7.9% vs. 8.3%; p<0.001). The proportions of patients who reported no hypoglycemic episodes were 22/62 and 9/62, with the 6-mm and 8-mm needles, respectively. The 6-mm needles were better in terms of the following parameters compared to 8-mm needles: mean needle attribute scores (36.7 vs. 24.2; p<0.001), median VAS pain scores (20 vs. 55; p<0.001), insulin leakage (6/62 vs. 20/62; p=0.002), and the MMAS score (4.9 vs. 3.4; p<0.001). Conclusion 1 1

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Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes

Cited by 26 publications

References 25 publications

Extraction and biomolecular analysis of dermal interstitial fluid collected with hollow microneedles

Extraction and biomolecular analysis of dermal interstitial fluid collected with hollow microneedles

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

Evaluating the User Preference and Level of Insulin Self-Administration Adherence in Young Patients With Type 1 Diabetes: Experience With Two Insulin Pen Needle Lengths

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