Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.

A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Lancing device A; Device: 28 G lancet; Other: Lancing depth setting (1); Other: Lancing depth setting (5); Device: 30 G lancet; Device: 33 G lancet; Device: Lancing device B; Device: Lancing device C

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 91-738
    • Nzoz Magmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with diagnosed diabetes type 1 or 2 ,
• aged 18 - 50,
• period of suffering from diabetes >2 years,
• performing on average 3-8 daily measurements of glycaemia,
• glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.

Exclusion Criteria:

• glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
• previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
• anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
• non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
• patients with signs of dehydration,
• patients who are currently participating in another clinical study,
• currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A/28/1; Lancing device A with personal lancet of size 28 G and minimum puncture depth.	Device: Lancing device A; Glucoject Dual Plus lancing device; Device: 28 G lancet; Droplet 28 G; Other: Lancing depth setting (1); The lowest depth setting (1)
Experimental: A/28/5; Lancing device A with personal lancet of size 28 G and maximum puncture depth.	Device: Lancing device A; Glucoject Dual Plus lancing device; Device: 28 G lancet; Droplet 28 G; Other: Lancing depth setting (5); The highest depth setting (5)
Experimental: A/30/1; Lancing device A with personal lancet of size 30 G and minimum puncture depth.	Device: Lancing device A; Glucoject Dual Plus lancing device; Other: Lancing depth setting (1); The lowest depth setting (1); Device: 30 G lancet; Droplet personal lancet 30 G
Experimental: A/30/5; Lancing device A with personal lancet of size 30 G and maximum puncture depth.	Device: Lancing device A; Glucoject Dual Plus lancing device; Other: Lancing depth setting (5); The highest depth setting (5); Device: 30 G lancet; Droplet personal lancet 30 G
Experimental: A/33/1; Lancing device A with personal lancet of size 33 G and minimum puncture depth.	Device: Lancing device A; Glucoject Dual Plus lancing device; Other: Lancing depth setting (1); The lowest depth setting (1); Device: 33 G lancet; Droplet personal lancet 33 G
Experimental: A/33/5; Lancing device A with personal lancet of size 33 G and maximum puncture depth.	Device: Lancing device A; Glucoject Dual Plus lancing device; Other: Lancing depth setting (5); The highest depth setting (5); Device: 33 G lancet; Droplet personal lancet 33 G
Experimental: B/28/1; Lancing device B with personal lancet of size 28 G and minimum puncture depth.	Device: 28 G lancet; Droplet 28 G; Other: Lancing depth setting (1); The lowest depth setting (1); Device: Lancing device B; Droplet lancing device
Experimental: B/28/5; Lancing device B with personal lancet of size 28 G and maximum puncture depth.	Device: 28 G lancet; Droplet 28 G; Other: Lancing depth setting (5); The highest depth setting (5); Device: Lancing device B; Droplet lancing device
Experimental: B/30/1; Lancing device B with personal lancet of size 30 G and minimum puncture depth.	Other: Lancing depth setting (1); The lowest depth setting (1); Device: 30 G lancet; Droplet personal lancet 30 G; Device: Lancing device B; Droplet lancing device
Experimental: B/30/5; Lancing device B with personal lancet of size 30 G and maximum puncture depth.	Other: Lancing depth setting (5); The highest depth setting (5); Device: 30 G lancet; Droplet personal lancet 30 G; Device: Lancing device B; Droplet lancing device
Experimental: B/33/1; Lancing device B with personal lancet of size 33 G and minimum puncture depth.	Other: Lancing depth setting (1); The lowest depth setting (1); Device: 33 G lancet; Droplet personal lancet 33 G; Device: Lancing device B; Droplet lancing device
Experimental: B/33/5; Lancing device B with personal lancet of size 33 G and maximum puncture depth.	Other: Lancing depth setting (5); The highest depth setting (5); Device: 33 G lancet; Droplet personal lancet 33 G; Device: Lancing device B; Droplet lancing device
Experimental: C/28/1; Lancing device C with personal lancet of size 28 G and minimum puncture depth.	Device: 28 G lancet; Droplet 28 G; Other: Lancing depth setting (1); The lowest depth setting (1); Device: Lancing device C; Commercially available lancing device
Experimental: C/28/5; Lancing device C with personal lancet of size 28 G and maximum puncture depth.	Device: 28 G lancet; Droplet 28 G; Other: Lancing depth setting (5); The highest depth setting (5); Device: Lancing device C; Commercially available lancing device
Experimental: C/30/1; Lancing device C with personal lancet of size 30 G and minimum puncture depth.	Other: Lancing depth setting (1); The lowest depth setting (1); Device: 30 G lancet; Droplet personal lancet 30 G; Device: Lancing device C; Commercially available lancing device
Experimental: C/30/5; Lancing device C with personal lancet of size 30 G and maximum puncture depth.	Other: Lancing depth setting (5); The highest depth setting (5); Device: 30 G lancet; Droplet personal lancet 30 G; Device: Lancing device C; Commercially available lancing device
Experimental: C/33/1; Lancing device C with personal lancet of size 33 G and minimum puncture depth.	Other: Lancing depth setting (1); The lowest depth setting (1); Device: 33 G lancet; Droplet personal lancet 33 G; Device: Lancing device C; Commercially available lancing device
Experimental: C/33/5; Lancing device C with personal lancet of size 33 G and maximum puncture depth.	Other: Lancing depth setting (5); The highest depth setting (5); Device: 33 G lancet; Droplet personal lancet 33 G; Device: Lancing device C; Commercially available lancing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume (uL) of blood in the capillary tube	Examination of the volume of blood obtained after puncturing a fingertip with the use of 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G). The volume of blood sample will be measured with the use of capillary tubes calibrated for the volume of 10 μl and a graduated ruler.	1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).	Examination of the intensity of pain perceived when puncturing a fingertip with the use of 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G).	1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Collaborators and Investigators

• Sponsor: HTL-Strefa S.A.
• Collaborators: Medical University of Lodz
• Investigators: Principal Investigator: Agnieszka Szadkowska, PhD,Md, Medical University of Lodz

Publications and helpful links

General Publications

• Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): May 14, 2018
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: lancing device; lancet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Pain
• Other Study ID Numbers: 010617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No