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Evaluation of lancets for pain perception and capillary blood volume for glucose monitoring.

Approximately 20.8 million adults and children in the US (or seven percent of the population) suffer from diabetes and depend on routine blood glucose monitoring to manage the condition and to reduce potential disease complications. Circumstances may present, however, in which patients fail to assess their blood glucose levels on a consistent basis, with real or perceived pain during finger punctures for low blood volume collection as a major factor. (5-7) In addition, these situations may result in an inability to retrieve an adequate blood sample for glucose testing.

In reference to this, the purpose of the study was to assess four currently marketed lancets for subjects' relative pain perception and capillary blood flow (volume) when used to perform finger punctures for glucose monitoring.

MATERIALS AND METHODS

A total of 10 nurses and phlebotomists, who currently perform finger-puncture procedures for the collection of low blood volumes, each performed four skin punctures on each of eight adult subjects utilizing four different lancets (BD Microtainer Contact-Activated Lancet, Low Flow; LifeScan OneTouch SureSoft Gentle; BD Genie Blue; SurgiLance Safety). All subjects were previously diagnosed with type I or type II diabetes mellitus and routinely underwent finger-puncture procedures for glucose monitoring. Following receipt of written informed patient consent, a skin puncture was achieved on each subject using all four devices in a randomized schedule that integrated the device, finger (third/middle or fourth/ring), and hand rotation. Prior to the punctures, a total of 80 subjects washed their hands with warm soapy water. Immediately prior to each skin puncture, the site was cleansed with 70% isopropyl alcohol and allowed to air dry. Each skin puncture was performed in accordance with the manufacturer's instructions for the specific device. To obtain the first drop of blood after device penetration, the clinician applied pressure above the puncture site for three to five seconds; pressure was then released. The first drop of blood was collected into a 75 [micro]L microcapillary tube; the fill height was measured against a scale (in millimeters), and the total volume was calculated.

After the puncture site was cleansed and bandaged, the subject assessed the perceived pain upon initial skin puncture ([t.sub.0]) using a Gracely Pain Scale--a nominal 0-20 rating scale, where 0 was defined as "no pain" and 20 as "excruciating pain." (8)

The skin puncture procedure was repeated until the subject received one puncture from each of the four devices. The pressure above the puncture site was kept at a constant time for each subject and among the four devices. This was accomplished by recording the pressure time for the first skin puncture and applying the same time to the three remaining device punctures. Upon completion of all four finger punctures, the subject was asked to identify the most and least painful of the four devices. In addition, each subject assessed lingering pain by gently rubbing the thumb over the skin puncture after approximately 5 min [+ or -]1 min ([t.sub.5 min]) and 10 min [+ or -]1 min ([t.sub.10 min]) after the first puncture for each hand.

The lower limit for blood volume collected from each device was not predetermined. Instead, this was assessed by each clinician based on the volume collected and their personal experience using point-of-care devices to determine glucose value.

DATA ANALYSIS

Data from the subjects for perceived pain and data from clinicians for capillary blood flow (volume) were obtained. Subjects' perceived pain evaluations on the Gracely Pain Scale (0-20 scale) were analyzed with a general linear model performed on the log transformed data. Analysis of variance (ANOVA) procedures, followed by a predetermined set of multiple comparisons, were used to determine whether there were significant differ ences among the four lancet types. The model used for the ANOVA was:

y = Order + Clinician + Subject + Hand + Finger + Lancet Type.

Dunnett's simultaneous tests were used for comparing the Contact-Activated Lancet with the other three lancet types. Descriptive statistics for the blood volume collected after each skin puncture, along with 95% confidence intervals for the mean volume were computed for each lancet type.

RESULTS AND DISCUSSION

Data were collected to assess pain perception (comfort) and capillary blood volume of the four lancets. Table 1 presents the range of study scores obtained for subjects' pain perception, which was the range of results obtained for each device for all subjects (80 subjects, four devices = 320 reported values). Also documented are the mean and standard deviation for each device, as well as the size of the study population.

Examination of the data revealed the mean value of subjects' perceived pain, with the Contact-Activated Lancet at the lowest with a scale mean of 1.80. In addition, this lancet had the lowest range in subjects' intensity of perceived pain, with a maximum Gracely Pain Scale score of 15 versus maximum scores of 19 and 20 for the remaining devices.

Results were then obtained for subject responses to the questions regarding lingering pain: Any pain on first finger puncture or following the first puncture on each hand? These questions were asked of each subject at 5 min ([t.sub.5 min]) and 10 min ([t.sub.10 min]) (Table 2). Results were then documented for all subjects, each device, each hand, and for each question (or question interval). None of the subjects felt lingering pain at [t.sub.5 min] or at [t.sub.10 min] when the Contact-Activated Lancet was used for skin penetration. Thirty-eight subjects (95%) felt no lingering pain at [t.sub.5 min] and 39 subjects (97.5%) experienced no lingering pain at [t.sub.10 min] when the OneTouch SureSoft Gentle Lancet was used. Thirty-nine subjects (97.5%) and 40 subjects (100%) felt no lingering pain at [t.sub.5 min] and at [t.sub.10 min] respectively when using BD Genie Blue. Thirty-two subjects (80%) and 36 subjects (90%) reported no lingering pain at [t.sub.5 min] and at [t.sub.10 min] respectively when using the SurgiLance Safety lancet.

Table 3 presents the units and range of results obtained for total blood volume, which was the range of results obtained for each device for all subjects using the same puncture pressure time across all lancets for each subject. Also shown are the mean, standard deviation, and median values for each device. Subjects' skin punctures from the Contact-Activated Lancet had the smallest amount of blood volume (bleeding) when compared to the other devices (mean = 6.39 [L, median 4.5 [L), while successfully providing an adequate sample volume when evaluated by the clinicians. The Contact-Activated Lancet generated significantly less blood than the SurgiLance Safety lancet. There were no significant differences between the other evaluated lancets.

CONCLUSION

This study demonstrated that the Contact-Activated Lancet elicited less perceived pain than the other lancet devices, which were evaluated in the research examination. In addition, the study confirmed the acquisition of an adequate capillary blood volume required for glucose monitoring in a diabetic population.

ACKNOWLEDGEMENTS: The authors wish to acknowledge Karen Byron for her help in the statistical analysis and Julie Ravo for her editorial assistance.

Clin Lab Sci encourages readers to respond with thoughts, questions, or comments regarding this article. Email responses to ic.ink@mchsi.com. In the subject line, please type "CLIN LAB SCI21(4) RR WARUNEK" : Selected responses will appear in the Dialogue and Discussion section in a future issue. Responses may be edited for length and clarity. We look forward to hearing from you.

REFERENCES

(1.) American Diabetes Association. NAACLS DMS accreditation information: standards documentation. Available from www.naacls. org/accreditation/dms. Accessed 2007 Nov 6.

(2.) Diabetes Public Health Resource. Centers for Disease Control and Prevention. Available from www.cdc.org. Accessed 2007 Nov 20.

(3.) Diabetes on the rise. Am J Nuts 2000;100(11):21.

(4.) Steinbrook R. Facing the diabetes epidemic-mandatory reporting of glycosylated hemoglobin values in New York City. N Eng J Med 2006;354(6):545-8.

(5.) Yum S1, Roe J. Capillary blood sampling for self-monitoring of blood glucose. Diabetes Technol Ther 1999;1(1):29-37.

(6.) Pacaud D, Lemay JF, Buithieu M, Yale JE Blood volumes and pain following capillary punctures in children and adolescents with diabetes. Diabetes Care 1999;22(9):1592-4.

(7.) Terrie YC. Blood glucose testing: Less pain, more to gain. Pharmacy Times Feb 2005:99-100.

(8.) Turk D, Melzack R. Handbook of pain assessment. 2nd ed. New York, NY: Guilford Press; 2001.

David Warunek PhD MBA MT(ASCP) is the worldwide director, Scientific Affairs, BD Diagnostics--Preanalytical Systems, Franklin Lakes NJ.

Ana StankovicPhDMDMSPHis the vicepresident, Medical, Scientific Affairs and Clinical Operations, BD Diagnostics--Preanalytical Systems, Franklin Lakes NJ

Address for correspondence: David Warunek PhD MBA MT (ASCP), worldwide director, ScientificAffairs BD Diagnostics--Preanalytical Systems, 1 Becton Drive, Franklin Lakes NJ 07417. (201) 847-4376. David_Warunek@bd.com.
Table 1. Pain perception: device, mean
and [+ or -] standard deviation (SD)

Device Contact- OneTouch
 Activated SureSoft
 Lancet Gentle

Study 0-15 0-19
range
across
each device
(Gracely
Pain Scale)

Mean 1.80 [+ or -] 3.23 2.66 [+ or -] 3.28
[+ or -] SD
(n=80)

p value * -- 0.0089

Device BD Genie SurgiLance
 Blue Safety Lancet

Study 0-20 0-19
range
across
each device
(Gracely
Pain Scale)

Mean 2.40 [+ or -] 3.45 3.14 [+ or -] 4.33
[+ or -] SD
(n=80)

p value * 0.0464 0.0026

* All data were expressed as mean [+ or -] SD. The difference between
the Contact-Activated Lancet and other devices for pain perception was
evaluated using the Dunnett's simultaneous test. p value <0.05 was
considered significant.

Table 2. Lingering pain, Response (n=80) *

Device Contact- OneTouch BD Genie SurgiLance
 Activated SureSoft Blue Safety Lancet
 Lancet Gentle

 [T.sub.5 minutes]
No 40 38 39 32
Yes 0 2 1 8
Percent 100% 95% 97.5% 80%

 [T.sub.10 minutes]
No 40 39 40 36
Yes 0 1 0 4
Percent 100% 97.5% 100% 90%

* Total values obtained = 160: 80 subjects, two hands. Question
was asked after each skin puncture with the first lancet on each
hand.

Table 3. Blood volume ([micro]L): device, range, mean
and 95% confidence intervals (95% CI), [+ or -] standard
deviation (SD), and median

Device Contact- OneTouch
 Activated SureSoft
 Lancet Gentle

Study 0-26 0-25
range
across
each device
([micro]L)

Mean ([micro]L) 6.39 8.09
(95% (5.26, 7.51) (6.96, 9.21)
C.I.)

SD 6.22 6.35
Median ([micro]L) 4.5 6.0
p value * -- 0.0923

Device BD Genie SurgiLance
 Blue Safety Lancet

Study 0-38 0-28
range
across
each device
([micro]L)

Mean ([micro]L) 7.15 8.75
(95% (6.02, 8.28) (7.62, 9.88)
C.I.)

SD 6.21 7.17
Median ([micro]L) 5.0 6.0
p value * 0.6633 0.0104

* All data were expressed as mean [+ or -] SD. The difference between
the Contact-Activated Lancet and other devices for blood volume
([micro]L) was evaluated using the Dunnett'ssimultaneous test.
p value <0.05 was considered significant.
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Title Annotation:RESEARCH AND REPORTS
Author:Warunek, David; Stankovic, Ana K.
Publication:Clinical Laboratory Science
Article Type:Report
Geographic Code:1USA
Date:Sep 22, 2008
Words:1821
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