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

NCT03479619 | Completed

• 1 other identifier: 010617
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

lancing device; lancet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).

  1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

Study Arms (18)

A/28/1

EXPERIMENTAL

Lancing device A with personal lancet of size 28 G and minimum puncture depth.

Device: Lancing device A; Device: 28 G lancet; Other: Lancing depth setting (1)

A/28/5

EXPERIMENTAL

Lancing device A with personal lancet of size 28 G and maximum puncture depth.

Device: Lancing device A; Device: 28 G lancet; Other: Lancing depth setting (5)

A/30/1

EXPERIMENTAL

Lancing device A with personal lancet of size 30 G and minimum puncture depth.

Device: Lancing device A; Device: 30 G lancet; Other: Lancing depth setting (1)

A/30/5

EXPERIMENTAL

Lancing device A with personal lancet of size 30 G and maximum puncture depth.

Device: Lancing device A; Device: 30 G lancet; Other: Lancing depth setting (5)

A/33/1

EXPERIMENTAL

Lancing device A with personal lancet of size 33 G and minimum puncture depth.

Device: Lancing device A; Device: 33 G lancet; Other: Lancing depth setting (1)

A/33/5

EXPERIMENTAL

Lancing device A with personal lancet of size 33 G and maximum puncture depth.

Device: Lancing device A; Device: 33 G lancet; Other: Lancing depth setting (5)

B/28/1

EXPERIMENTAL

Lancing device B with personal lancet of size 28 G and minimum puncture depth.

Device: Lancing device B; Device: 28 G lancet; Other: Lancing depth setting (1)

B/28/5

EXPERIMENTAL

Lancing device B with personal lancet of size 28 G and maximum puncture depth.

Device: Lancing device B; Device: 28 G lancet; Other: Lancing depth setting (5)

B/30/1

EXPERIMENTAL

Lancing device B with personal lancet of size 30 G and minimum puncture depth.

Device: Lancing device B; Device: 30 G lancet; Other: Lancing depth setting (1)

B/30/5

EXPERIMENTAL

Lancing device B with personal lancet of size 30 G and maximum puncture depth.

Device: Lancing device B; Device: 30 G lancet; Other: Lancing depth setting (5)

B/33/1

EXPERIMENTAL

Lancing device B with personal lancet of size 33 G and minimum puncture depth.

Device: Lancing device B; Device: 33 G lancet; Other: Lancing depth setting (1)

B/33/5

EXPERIMENTAL

Lancing device B with personal lancet of size 33 G and maximum puncture depth.

Device: Lancing device B; Device: 33 G lancet; Other: Lancing depth setting (5)

C/28/1

EXPERIMENTAL

Lancing device C with personal lancet of size 28 G and minimum puncture depth.

Device: Lancing device C; Device: 28 G lancet; Other: Lancing depth setting (1)

C/28/5

EXPERIMENTAL

Lancing device C with personal lancet of size 28 G and maximum puncture depth.

Device: Lancing device C; Device: 28 G lancet; Other: Lancing depth setting (5)

C/30/1

EXPERIMENTAL

Lancing device C with personal lancet of size 30 G and minimum puncture depth.

Device: Lancing device C; Device: 30 G lancet; Other: Lancing depth setting (1)

C/30/5

EXPERIMENTAL

Lancing device C with personal lancet of size 30 G and maximum puncture depth.

Device: Lancing device C; Device: 30 G lancet; Other: Lancing depth setting (5)

C/33/1

EXPERIMENTAL

Lancing device C with personal lancet of size 33 G and minimum puncture depth.

Device: Lancing device C; Device: 33 G lancet; Other: Lancing depth setting (1)

C/33/5

EXPERIMENTAL

Lancing device C with personal lancet of size 33 G and maximum puncture depth.

Device: Lancing device C; Device: 33 G lancet; Other: Lancing depth setting (5)

Interventions

Lancing device A DEVICE

Glucoject Dual Plus lancing device

A/28/1; A/28/5; A/30/1; A/30/5; A/33/1; A/33/5

Lancing device B DEVICE

Droplet lancing device

B/28/1; B/28/5; B/30/1; B/30/5; B/33/1; B/33/5

Lancing device C DEVICE

Commercially available lancing device

C/28/1; C/28/5; C/30/1; C/30/5; C/33/1; C/33/5

28 G lancet DEVICE

Droplet 28 G

A/28/1; A/28/5; B/28/1; B/28/5; C/28/1; C/28/5

30 G lancet DEVICE

Droplet personal lancet 30 G

A/30/1; A/30/5; B/30/1; B/30/5; C/30/1; C/30/5

33 G lancet DEVICE

Droplet personal lancet 33 G

A/33/1; A/33/5; B/33/1; B/33/5; C/33/1; C/33/5

Lancing depth setting (1) OTHER

The lowest depth setting (1)

A/28/1; A/30/1; A/33/1; B/28/1; B/30/1; B/33/1; C/28/1; C/30/1; C/33/1

Lancing depth setting (5) OTHER

The highest depth setting (5)

A/28/5; A/30/5; A/33/5; B/28/5; B/30/5; B/33/5; C/28/5; C/30/5; C/33/5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HTL-Strefa S.A.: lead
• Medical University of Lodz: collaborator

Study Sites (1)

Nzoz Magmed

Lodz, 91-738, Poland

Location

Related Publications (1)

• 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.

  PMID: 32856497 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Agnieszka Szadkowska, PhD,Md

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: March 6, 2018
• Primary Completion: May 14, 2018
• Study Completion: September 27, 2018
• Last Updated: February 5, 2020

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)