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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Lancing device A
Lancing device B
Lancing device C
28 G lancet
30 G lancet
33 G lancet
Lancing depth setting (1)
Lancing depth setting (5)
Sponsored by
HTL-Strefa S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring lancing device, lancet

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nzoz Magmed

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A/28/1

A/28/5

A/30/1

A/30/5

A/33/1

A/33/5

B/28/1

B/28/5

B/30/1

B/30/5

B/33/1

B/33/5

C/28/1

C/28/5

C/30/1

C/30/5

C/33/1

C/33/5

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
March 20, 2018
Last Updated
January 30, 2020
Sponsor
HTL-Strefa S.A.
Collaborators
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT03479619
Brief Title
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
Official Title
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
May 14, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HTL-Strefa S.A.
Collaborators
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
lancing device, lancet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A/28/1
Arm Type
Experimental
Arm Description
Lancing device A with personal lancet of size 28 G and minimum puncture depth.
Arm Title
A/28/5
Arm Type
Experimental
Arm Description
Lancing device A with personal lancet of size 28 G and maximum puncture depth.
Arm Title
A/30/1
Arm Type
Experimental
Arm Description
Lancing device A with personal lancet of size 30 G and minimum puncture depth.
Arm Title
A/30/5
Arm Type
Experimental
Arm Description
Lancing device A with personal lancet of size 30 G and maximum puncture depth.
Arm Title
A/33/1
Arm Type
Experimental
Arm Description
Lancing device A with personal lancet of size 33 G and minimum puncture depth.
Arm Title
A/33/5
Arm Type
Experimental
Arm Description
Lancing device A with personal lancet of size 33 G and maximum puncture depth.
Arm Title
B/28/1
Arm Type
Experimental
Arm Description
Lancing device B with personal lancet of size 28 G and minimum puncture depth.
Arm Title
B/28/5
Arm Type
Experimental
Arm Description
Lancing device B with personal lancet of size 28 G and maximum puncture depth.
Arm Title
B/30/1
Arm Type
Experimental
Arm Description
Lancing device B with personal lancet of size 30 G and minimum puncture depth.
Arm Title
B/30/5
Arm Type
Experimental
Arm Description
Lancing device B with personal lancet of size 30 G and maximum puncture depth.
Arm Title
B/33/1
Arm Type
Experimental
Arm Description
Lancing device B with personal lancet of size 33 G and minimum puncture depth.
Arm Title
B/33/5
Arm Type
Experimental
Arm Description
Lancing device B with personal lancet of size 33 G and maximum puncture depth.
Arm Title
C/28/1
Arm Type
Experimental
Arm Description
Lancing device C with personal lancet of size 28 G and minimum puncture depth.
Arm Title
C/28/5
Arm Type
Experimental
Arm Description
Lancing device C with personal lancet of size 28 G and maximum puncture depth.
Arm Title
C/30/1
Arm Type
Experimental
Arm Description
Lancing device C with personal lancet of size 30 G and minimum puncture depth.
Arm Title
C/30/5
Arm Type
Experimental
Arm Description
Lancing device C with personal lancet of size 30 G and maximum puncture depth.
Arm Title
C/33/1
Arm Type
Experimental
Arm Description
Lancing device C with personal lancet of size 33 G and minimum puncture depth.
Arm Title
C/33/5
Arm Type
Experimental
Arm Description
Lancing device C with personal lancet of size 33 G and maximum puncture depth.
Intervention Type
Device
Intervention Name(s)
Lancing device A
Intervention Description
Glucoject Dual Plus lancing device
Intervention Type
Device
Intervention Name(s)
Lancing device B
Intervention Description
Droplet lancing device
Intervention Type
Device
Intervention Name(s)
Lancing device C
Intervention Description
Commercially available lancing device
Intervention Type
Device
Intervention Name(s)
28 G lancet
Intervention Description
Droplet 28 G
Intervention Type
Device
Intervention Name(s)
30 G lancet
Intervention Description
Droplet personal lancet 30 G
Intervention Type
Device
Intervention Name(s)
33 G lancet
Intervention Description
Droplet personal lancet 33 G
Intervention Type
Other
Intervention Name(s)
Lancing depth setting (1)
Intervention Description
The lowest depth setting (1)
Intervention Type
Other
Intervention Name(s)
Lancing depth setting (5)
Intervention Description
The highest depth setting (5)
Primary Outcome Measure Information:
Title
Volume (uL) of blood in the capillary tube
Description
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.
Time Frame
1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Secondary Outcome Measure Information:
Title
The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).
Description
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).
Time Frame
1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Szadkowska, PhD,Md
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nzoz Magmed
City
Lodz
ZIP/Postal Code
91-738
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32856497
Citation
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.
Results Reference
derived

Learn more about this trial

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

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