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

Not Applicable

Completed

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

• Registration Number: NCT03479619
• Lead Sponsor: HTL-Strefa S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Primary Completion: 2018-05-14
• Study Completion: 2018-09-27
• Status Verified: 2018-11
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C/28/1	Lancing depth setting (1)	Lancing device C with personal lancet of size 28 G and minimum puncture depth.
C/28/5	Lancing device C	Lancing device C with personal lancet of size 28 G and maximum puncture depth.
C/28/5	Lancing depth setting (5)	Lancing device C with personal lancet of size 28 G and maximum puncture depth.
C/30/1	30 G lancet	Lancing device C with personal lancet of size 30 G and minimum puncture depth.
C/28/1	Lancing device C	Lancing device C with personal lancet of size 28 G and minimum puncture depth.
A/28/1	28 G lancet	Lancing device A with personal lancet of size 28 G and minimum puncture depth.
A/28/5	28 G lancet	Lancing device A with personal lancet of size 28 G and maximum puncture depth.
B/30/1	Lancing device B	Lancing device B with personal lancet of size 30 G and minimum puncture depth.
B/33/1	Lancing device B	Lancing device B with personal lancet of size 33 G and minimum puncture depth.
A/28/1	Lancing device A	Lancing device A with personal lancet of size 28 G and minimum puncture depth.
A/28/5	Lancing device A	Lancing device A with personal lancet of size 28 G and maximum puncture depth.
B/33/5	Lancing depth setting (5)	Lancing device B with personal lancet of size 33 G and maximum puncture depth.
A/28/1	Lancing depth setting (1)	Lancing device A with personal lancet of size 28 G and minimum puncture depth.
C/33/5	Lancing device C	Lancing device C with personal lancet of size 33 G and maximum puncture depth.
A/28/5	Lancing depth setting (5)	Lancing device A with personal lancet of size 28 G and maximum puncture depth.
A/30/1	Lancing device A	Lancing device A with personal lancet of size 30 G and minimum puncture depth.
B/28/1	Lancing device B	Lancing device B with personal lancet of size 28 G and minimum puncture depth.
B/28/5	Lancing depth setting (5)	Lancing device B with personal lancet of size 28 G and maximum puncture depth.
C/33/5	33 G lancet	Lancing device C with personal lancet of size 33 G and maximum puncture depth.
A/30/1	Lancing depth setting (1)	Lancing device A with personal lancet of size 30 G and minimum puncture depth.
A/30/5	30 G lancet	Lancing device A with personal lancet of size 30 G and maximum puncture depth.
B/28/1	Lancing depth setting (1)	Lancing device B with personal lancet of size 28 G and minimum puncture depth.
B/28/5	28 G lancet	Lancing device B with personal lancet of size 28 G and maximum puncture depth.
B/30/5	30 G lancet	Lancing device B with personal lancet of size 30 G and maximum puncture depth.
C/30/5	Lancing device C	Lancing device C with personal lancet of size 30 G and maximum puncture depth.
C/30/5	Lancing depth setting (5)	Lancing device C with personal lancet of size 30 G and maximum puncture depth.
A/30/1	30 G lancet	Lancing device A with personal lancet of size 30 G and minimum puncture depth.
A/30/5	Lancing depth setting (5)	Lancing device A with personal lancet of size 30 G and maximum puncture depth.
A/33/1	Lancing device A	Lancing device A with personal lancet of size 33 G and minimum puncture depth.
A/33/1	Lancing depth setting (1)	Lancing device A with personal lancet of size 33 G and minimum puncture depth.
A/33/5	Lancing device A	Lancing device A with personal lancet of size 33 G and maximum puncture depth.
A/33/5	Lancing depth setting (5)	Lancing device A with personal lancet of size 33 G and maximum puncture depth.
B/28/1	28 G lancet	Lancing device B with personal lancet of size 28 G and minimum puncture depth.
B/30/5	Lancing depth setting (5)	Lancing device B with personal lancet of size 30 G and maximum puncture depth.
C/28/1	28 G lancet	Lancing device C with personal lancet of size 28 G and minimum puncture depth.
C/30/5	30 G lancet	Lancing device C with personal lancet of size 30 G and maximum puncture depth.
A/30/5	Lancing device A	Lancing device A with personal lancet of size 30 G and maximum puncture depth.
A/33/1	33 G lancet	Lancing device A with personal lancet of size 33 G and minimum puncture depth.
B/28/5	Lancing device B	Lancing device B with personal lancet of size 28 G and maximum puncture depth.
B/30/1	Lancing depth setting (1)	Lancing device B with personal lancet of size 30 G and minimum puncture depth.
B/30/5	Lancing device B	Lancing device B with personal lancet of size 30 G and maximum puncture depth.
B/33/1	Lancing depth setting (1)	Lancing device B with personal lancet of size 33 G and minimum puncture depth.
A/33/5	33 G lancet	Lancing device A with personal lancet of size 33 G and maximum puncture depth.
B/30/1	30 G lancet	Lancing device B with personal lancet of size 30 G and minimum puncture depth.
B/33/1	33 G lancet	Lancing device B with personal lancet of size 33 G and minimum puncture depth.
B/33/5	Lancing device B	Lancing device B with personal lancet of size 33 G and maximum puncture depth.
C/28/5	28 G lancet	Lancing device C with personal lancet of size 28 G and maximum puncture depth.
C/30/1	Lancing device C	Lancing device C with personal lancet of size 30 G and minimum puncture depth.
B/33/5	33 G lancet	Lancing device B with personal lancet of size 33 G and maximum puncture depth.
C/30/1	Lancing depth setting (1)	Lancing device C with personal lancet of size 30 G and minimum puncture depth.
C/33/1	Lancing device C	Lancing device C with personal lancet of size 33 G and minimum puncture depth.
C/33/1	33 G lancet	Lancing device C with personal lancet of size 33 G and minimum puncture depth.
C/33/1	Lancing depth setting (1)	Lancing device C with personal lancet of size 33 G and minimum puncture depth.
C/33/5	Lancing depth setting (5)	Lancing device C with personal lancet of size 33 G and maximum puncture depth.

Primary Outcome Measures

Name	Time	Method
Volume (uL) of blood in the capillary tube	1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min	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.

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Nzoz Magmed; 🇵🇱 Lodz, Poland