A Pain-free Lancet with a Small Needle for Glucose ...

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Abstract

A recently developed lancet featuring an exceptionally small needle, measuring 0.15 mm in diameter and 0.75 mm in length, was assessed in a randomized clinical study involving diabetic patients for blood glucose measurement. The study included 37 participants. A pain scale ranging from 0 to 3 was devised to quantify the pain experienced during punctures, as explained to the patients prior to testing. Each patient's finger was initially punctured with a traditional lancet at least one hour before the new lancet was used, tracking the pain level according to the established scale. All participants reported no pain with the new lancet, categorizing their experience as scale 0. In contrast, when using their previous lancets, only 2 out of the 37 patients (5.40%) noted no pain (scale 0), 13 patients (35.14%) rated it as scale 1, 16 patients (43.24%) as scale 2, and 6 patients (16.22%) as scale 3. The overall average pain scale for those using older models was 1.702, with a standard error of 0.133. The chi-square goodness-of-fit test indicated that pain scale distributions differed significantly, and tests for independence revealed no correlation between pain scales and the patients' sex or age.

A paired t-test analyzing the difference in pain levels between the new and old lancets yielded results of t = 1.702/0.133 = 12.796, with a p-value < 0.005 (df = 36). Findings indicate that discomfort experienced with traditional lancets significantly exceeds that associated with the new ones. This pain-free puncture technique was successfully achieved by restricting the depth of penetration to less than 0.75 mm and using a needle of just 0.15 mm in diameter. Moreover, allowing patients to observe the new lancets ahead of use helped alleviate psychological pain anticipation, as the needle's visual appearance was less daunting. This advancement may enhance patient compliance and consequently improve glucose control.

Keywords:

lancet, glucose measurement, pain free, small needle

Introduction

Recent years have seen significant advancements in diabetes management, particularly in glucose monitoring technology. Nonetheless, the lancet technology has lagged, resulting in ongoing discomfort for many diabetic patients during blood sugar measurements. Many patients still resort to older lancet designs, which were introduced over three decades ago and feature thicker, longer needles for finger punctures.

Additionally, the same-sized lancets are used for both adults and children as there are no specialized lancets designed for diabetic children. Traditional stainless steel lancets have a diameter of 0.3–0.8 mm and penetrate between 0.7 to 1.3 mm, with the depth of penetration directly linked to pain levels.1 While a thinner and shorter needle minimizes tissue damage and pain, it typically yields insufficient blood volume for glucose testing. Modern glucose monitors need smaller blood samples for precise readings, making the use of large-sized needles obsolete. For instance, the FreeStyle® glucose meter by Abbott requires only 0.3 microliters of blood for accurate glucose monitoring.2 Many diabetic patients, discouraged by the pain associated with traditional lancets, do not test their blood sugar as regularly as suggested, which adversely affects their health. A survey of around 6,600 type 1 diabetic patients revealed a notable difference between recommended and actual testing frequencies largely attributed to pain and discomfort. This discrepancy correlates with increased hospitalizations over the previous two years,1 highlighting that poor compliance can lead to diabetes complications.

The introduction of a new lancet, featuring a slender and short needle, was evaluated in an open randomized clinical study to determine its efficacy in minimizing puncture sensations compared to conventional models while ensuring adequate blood volume for glucose testing.

Methods

The study comprised 37 diabetic individuals (3 with type 1 diabetes and 34 with type 2 diabetes) conducted from April 2 to December 31. The sample included 12 females (32.4%) and 25 males (67.6%), with ages ranging from 24 to 88 years and an average age of 66.6 years. Of the participants, 16 were below 66 years old, and 21 were aged over 66 years.

Table 1.

Patient no.SexAgeBrand of old lancetPain scale from old lancetPain scale from new lancet P01M62OneTouch20P02M64Generic10P03M70AccuChek20P04M68Ascensia30P05M68Ascensia30P06F80AccuChek10P07M67Generic30P08M57FreeStyle20P09F70OneTouch20P10M63AccuChek10P11M70OneTouch20P12M70OneTouch20P13F75OneTouch10P14M58AccuChek10P15M62OneTouch30P16F80OneTouch20P17F77AccuChek20P18M78BD30G10P19F47AccuChek20P20F49OneTouch10P21M24BD30G10P22M61AccuChek20P23M83OneTouch10P24M67OneTouch20P25M88AccuChek00P26F58OneTouch30P27M67FreeStyle10P28M68Ascensia30P29M62FreeStyle20P30F61OneTouch20P31F84Generic20P32M63OneTouch20P33F76OneTouch00P34M70OneTouch10P35F66OneTouch10P36M61AccuChek10P37M71AccuChek20Open in a separate window

Each participant was using their own traditional disposable lancets of various types, including OneTouch® (Life Scan, Milpitas, California), AccuChek softclix® (Roche Diagnostics, Indianapolis, Indiana), FreeStyle® (Abbott Laboratory, Abbott Park, Illinois), Ascencia® (Bayer Health Care LLC, Tarrytown, New York), and BD Ultrasoft® (BD, Franklin Lakes, New Jersey). The diameter of these lancet needles varied between 28 and 30 gauge, and their lengths ranged from 2.8 mm to 3.2 mm.

A novel disposable lancet, the Tiniboy® (Health Innovation Ideas, LLC, Upland, California), features a 38 gauge (0.15 mm diameter) and a length of 0.75 mm. The comparative image of Tiniboy® alongside other lancets is displayed.

Open in a separate window

For the procedure, the OneTouch® lancing device (Life Scan, Milpitas, California) was utilized with the Tiniboy® lancet, while blood glucose levels were measured with the OneTouch® glucose monitor (Life Scan, Milpitas, California), which requires at least 1.0 microliters of blood for testing. Patients used their own disposable lancets in their habitual manner as a control, with their first punctures occurring no less than 1 hour before the implementations of the new lancets.

All patients underwent testing at their fingertip, using comparable sites for both new and old lancets. Fingers were cleaned with an alcohol swab and dried with sterile gauze, followed by puncturing performed by a physician. Patients viewed the new lancet beforehand to ease any anxiety surrounding the procedure. The lancing device was carefully opened, and the disposable lancet loaded into its holder before closure and cocking. Typically, the 3rd and 4th fingertips were selected for the tests.

Initially, a penetration depth of level 1 on a scale of 9 was set on the lancing device. In instances where the initial attempt did not yield adequate blood volume for glucose testing, the depth was increased to level 2, and subsequently level 3 if necessary.

A simple pain scale was established; patients rated puncture discomfort on a scale from 0 to 3 (0 indicating no pain, 1 for minimal, 2 for mild pain, and 3 for moderate or severe discomfort). Patients were instructed on this scale prior to testing. Data on their pain experiences with both the new and older lancets were subsequently collected and recorded.

Table 2.

ScaleIntensity of pain0No pain1Minimal pain2Mild pain3Moderate or severe painOpen in a separate window

Results

Sampling success was achieved in the first attempt for 19 participants (51%), the second attempt for 17 individuals (46%), and the third attempt for 1 participant (3%).

All participants using the new lancet indicated no pain, marking their experience as scale 0 ( ). Among the 37 participants using their old lancets, only 2 patients (5.40%) felt no pain (scale 0), while 13 (35.14%) rated as scale 1, 16 (43.24%) as scale 2, and 6 (16.22%) as scale 3 ( ). The average pain scale for those using older models was 1.702, with a standard error of 0.133.

Table 3.

Pain scale0123FrequencyPercentage100%0%0%0%Open in a separate window

Table 3b.

Pain scale0123FrequencyPercentage5.40%35.14%43.24%16.22%Open in a separate window

The chi-square goodness-of-fit test ( ) demonstrated substantial evidence at the 5% significance level, indicating the frequency distribution of pain scores deviates from expected distributions; chi-square = 13.270 with a p-value < 0.01.

Chi-square tests for independence ( ) highlighted the lack of a relationship between pain scale and both sex and age within the sample ( ).

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Table 4.

Pain scale0123MaleFemaleOpen in a separate window

Table 4b.

Pain scale0123&#;66 years>66 yearsOpen in a separate window

Table 4c.

CategoryChi-square statisticsp-valueContingency coefficientSex vs. pain scale1...Age vs. pain scale2...Open in a separate window

The paired t-test results affirmed that there was a significant difference in pain levels between the new and old lancets with values of t = 1.702/0.133 = 12.796 and p-value < 0.005 (df = 36). Hence, the analysis concluded that average discomfort levels from the traditional lancets significantly exceeded those from the new ones.

Discussion

Among the numerous challenges faced by diabetic patients, the continual pain and tenderness in their fingers is significant. While the pain itself may not constitute a serious medical concern, it is indirectly tied to severe diabetes complications. Patients frequently refrain from measuring their blood glucose levels due to anxiety over potential puncture pain, leading to widespread non-compliance. The findings from this open randomized clinical study confirm that by reducing the lancet's needle size to 38 gauge and limiting its penetration depth to 0.75 mm, puncture discomfort can be effectively eradicated. Moreover, the blood volume achieved with this minimally invasive puncture was sufficient for glucose testing when using modern monitors. Technological advancements facilitate accurate measurements with as little as 0.3 microliters of blood.2

The rationale behind utilizing this painless needle piercing can be understood from both biological and psychological standpoints. The Tiniboy® lancet's uniquely narrow and short needle creates a minor and shallow puncture, likely targeting the capillaries in the upper dermis and bypassing deeper pain nerve fibers.

Furthermore, the apprehension of puncture pain can be mitigated by employing a very small needle, rendering the procedure less daunting for patients.

Human skin comprises the epidermis and dermis. The epidermis, void of blood vessels and pain nerve endings, lies above the dermis, which is segmented into two layers; the papillary layer on top and the reticular layer underneath. Typically, the papillary layer's superficial section is arranged into dermal papillae that encompass microvascular and neural components sustaining the epidermis. A vascular network, the rete subpapillare, outlines the base of the papillary dermis.3

The normal epidermal thickness for middle fingers is about 0.3 mm, with dermal thickness around 1.5 mm.4 The papillary layer measures approximately 0.3 mm to 0.4 mm thick.3

Nerve receptors such as Merkel's cells in the epidermis and Morgagni's corpuscles in the papillary layer respond to touch sensations.

Thus, if a lancet needle penetrates the skin to a depth of 0.6 mm to 0.7 mm, it can reach the rete subpapillae, the superficial vascular structures within the papillary dermis, without deeper traversal to the reticular dermis, where abundant pain nerve fibers reside. By only affecting the papillary dermis, lancet needles may stimulate touch receptors like the Merkel's cells and Morgagni's corpuscles, allowing patients to feel mere contact rather than distressing pain.

The constrained penetration depth (maximum of 0.75 mm) coupled with the remarkably fine needle (38 gauge) of the Tiniboy® lancet likely explains the consistent pain-free experiences reported by the participants. Furthermore, the novel design, featuring a small pedestal, supports the functionality of this extremely narrow and short needle. Conventional lancing devices generally have an exit aperture with a diameter of around 3 mm, with side walls approximately 1 mm thick. Consequently, traditional lancet needles, which are often longer than 1 mm, cannot make contact with the skin; thus, they predominantly feature lengths of about 3 mm. The Tiniboy®, however, is engineered with a compact pedestal of 2.25 mm in height and 1.75 mm in diameter at its distill end, onto which the 0.75 mm needle is mounted. During application, it is the small pedestal that traverses the exit opening while the needle remains protected. The entire length of the Tiniboy® lancet, consisting of the needle, pedestal, and body, matches that of older designs, permitting interchangeable use with traditional lancets and standard lancing devices.

Moreover, needle length influences thickness. Longer, thinner needles tend to bend or potentially break when in contact with particularly hard skin. The incorporation of the pedestal design in the lancing device allows a lancet needle to stay shorter than 1 mm, making it feasible to construct a very slender needle without risk of structural failure.

Another contributing factor to the pain-free puncturing experience may be a reduced overall dwelling time of the lancet needle inside the skin post-actuation. This can be attributed to the smaller contact area between the skin and both the lancet body and needle due to the diminutive distal surface area of the pedestal and the decreased surface area of the thinner, shorter lancet needle. Thus, there is a reduction in frictional force between the skin and the lancet needle and body. An enlarged surface area on the pedestal could result in heightened discomfort during punctures due to increased friction.

The psychological impact of pain perception should not be overlooked when evaluating pain intensity. Perception can be influenced not just by actual trauma size but also by psychological factors. The anticipation of pain translates into actual pain experiences.5 This is notably the case when diabetic patients self-administer finger punctures.

Handling the psychological aspects of pain anticipation was crucial in the current study. Recognizing that seeing the Tiniboy® lancet beforehand could mitigate fears about the procedure, patients were permitted to observe the device prior to the puncturing act, which was anticipated to result in decreased discomfort when compared to control lancets. However, conducting a randomized study with a double-blind methodology would generally be more scientifically ideal.

The findings of this study affirm the benefits associated with the new lancet, establishing it as a much-needed innovation. The absence of a control group may limit the ability to generalize results. Nonetheless, the compact design promises comparably less pain and increased utility for pediatric patients. Remarkably, all 37 tested subjects reported feeling no discomfort. Future research might explore whether compliance improves and blood glucose regulation is enhanced by assessing hemoglobin A1C levels in randomized controlled trials utilizing the new Tiniboy® lancet.

Special Acknowledgement for Statistical Analysis

Hoon Kim, Ph.D., Associate Professor of Statistics, Department of Mathematics and Statistics, California State Polytechnic University at Pomona, USA.

Footnotes

Financial Disclosure

Stanley Kim is the inventor of the Tiniboy® lancet, and is the founder of the Health innovation Ideas, LLC at 421 East 25th Street, Upland, CA , USA.

Disclosure

This manuscript has been read and approved by the author. This paper is unique and is not under consideration by any other publication and has not been published elsewhere.

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