Insulin Leakage Value in Relation to Pen Needle Length and Administered Dose After Subcutaneous Injection

Wittmann, Andreas; Köver, Jan; Kralj, Nenad; Gasthaus, Klaus; Lerch, H; Rommel, Marc; Moses, Susanne; Hofmann, Friedrich

doi:10.1089/dia.2010.0050

Cited by 26 publications

(25 citation statements)

References 6 publications

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“…21 Other studies have quantified skin leakage injections using needles as short as 4.5 mm and found only fractions of a unit of leakage (at most about 3.5% of the amount injected), even at injection volumes equivalent to 60 units-with the amount of leakage linked to dose, but not to needle length. [22][23][24] Many obese patients with type 2 diabetes have upper body segment fat distribution that is predominantly visceral; hence it cannot be assumed that there is excessive SC adipose tissue for injections in the thigh, 25,26 where minimum D was only 2.9 mm in our population. Furthermore, three-quarters of patients reported they inject insulin at 90°, and one-fourth indicated they do not pinch up at the thigh.…”

Section: Discussionmentioning

confidence: 86%

Intramuscular Risk at Insulin Injection Sites—Measurement of the Distance from Skin to Muscle and Rationale for Shorter-Length Needles for Subcutaneous Insulin Therapy

Hirsch

Byron

Gibney

2014

Diabetes Technology & Therapeutics

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Section: Discussionmentioning

confidence: 86%

Intramuscular Risk at Insulin Injection Sites—Measurement of the Distance from Skin to Muscle and Rationale for Shorter-Length Needles for Subcutaneous Insulin Therapy

Hirsch

Byron

Gibney

2014

Diabetes Technology & Therapeutics

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“…However, reports of bent needles were infrequent, and insulin leakage was also rare in our study. Wittmann et al 19 reported that the needle length did not have a marked effect on the amount of insulin leakage. Their conclusions were based on an experimental model using pork rinds, and our results support their findings in humans.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Effects of a New 32-Gauge×4-mm Pen Needle and a 32-Gauge×6-mm Pen Needle on Glycemic Control, Safety, and Patient Ratings in Japanese Adults with Diabetes

Miwa

Itoh

Kobayashi

et al. 2012

Diabetes Technology & Therapeutics

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“…8,[19][20][21] In 1 study, the volume of the injection did not affect the frequency of leakage. 3 In accordance with most previous studies, we found that larger Leakage data from the pig study.…”

Section: Leakage Influenced By Injection Techniquementioning

confidence: 99%

“…8 The relative amount of leakage did not differ for different injected volumes, which is also in line with a published study. 21 The reason for the injection volume dependency could be an increased tissue pressure on the insulin deposition from the surrounding subcutaneous tissue. Thereby, a larger amount of leakage could be pushed out of the needle puncture.…”

Section: Leakage Influenced By Injection Techniquementioning

confidence: 99%

“…21 In both the clinical trial 8 and present pig study, a leakage comparison scale was used as volume estimation of leakage after injection. The method was chosen because the scale method with the filter paper strips mounted on graph paper made it easy to discriminate by approximately 0.5 µL, and it was feasible to use.…”

Section: Strengths Limitations and Future Workmentioning

confidence: 99%

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Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections

Præstmark

Stallknecht

Jensen

et al. 2016

J Diabetes Sci Technol

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When administering insulin via subcutaneous injections, consistency of the injection and dose accuracy are essential; the user must receive the dialed and expected dose of insulin. One commonly known and well discussed event, which may occur after an injection, is the leakage of fluid out of the skin at the injection site, commonly referred to as either leakage or backflow.Studies indicate that the amount of detected leakage is not of clinical significance.1-4 However, leakage influences the patient perception of insulin administration, because the patients are concerned whether they have received the correct dosage.5-7 Therefore, clinicians may be consulted by concerned patients to support their choice of injection technique and pen needle.The present article investigates how different injection techniques and needle design factors potentially influence the volume and frequency of leakage following subcutaneous injections. Identified from a literature study of leakage, these factors were chosen to be injection region (abdomen or thighs), injection volume, injection speed, needle wall thickness, needle taper (outer shape of needle), needle insertion angle into the skin, and wait time after an injection until the needle is withdrawn from the skin. The 3 first mentioned factors were informed by analyzing unpublished leakage data from a previous clinical trial, 8 and the 4 latter factors were investigated in an exploratory leakage study on pigs. See Table 1 for an overview of the identified factors potentially influencing leakage, and our choice of data to substantiate our recommendation pertaining to these factors. Method: Leakage data were obtained from a post hoc analysis of clinical trial data and from a pig study. Data from the clinical study were used to determine leakage as a function of injection volume, speed and region. Data from the pig study were used to determine leakage as a function of needle wall thickness, needle taper, injection angle, and wait time from end of injection to withdrawal of needle from skin.Results: Leakage volume was positively related to injection volume. Injections in the abdomen caused less leakage than thigh injections. A 32G needle caused less leakage than a 31G and a 32G tip (tapered) needle, and a "straight in" 90° needle insertion angle caused less leakage than an angled (~45°) insertion. Wait times of minimum 3 seconds caused less leakage than immediate withdrawal of the needle after injection. Needle wall thickness and injection speed did not influence leakage.Conclusions: Leakage will be minimized using a thin needle, using 90° needle insertion in the abdomen, injecting maximum 800 µL at a time, and waiting at least 3 seconds after the injection until the needle is withdrawn from the skin.

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Insulin Leakage Value in Relation to Pen Needle Length and Administered Dose After Subcutaneous Injection

Abstract: The needle length (between 12 mm and 4.5 mm) did not have a meaningful influence on the amount of leakage; however, significant differences with different needle lengths could be observed.

Cited by 26 publications

References 6 publications

Intramuscular Risk at Insulin Injection Sites—Measurement of the Distance from Skin to Muscle and Rationale for Shorter-Length Needles for Subcutaneous Insulin Therapy

Intramuscular Risk at Insulin Injection Sites—Measurement of the Distance from Skin to Muscle and Rationale for Shorter-Length Needles for Subcutaneous Insulin Therapy

Comparison of the Effects of a New 32-Gauge×4-mm Pen Needle and a 32-Gauge×6-mm Pen Needle on Glycemic Control, Safety, and Patient Ratings in Japanese Adults with Diabetes

Injection Technique and Pen Needle Design Affect Leakage From Skin After Subcutaneous Injections

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