Back to results

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)

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

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

NCT ID

NCT03479619

First Posted

March 20, 2018

Last Updated

January 30, 2020

Sponsor

HTL-Strefa S.A.

Collaborators

Medical University of Lodz

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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.

We'll reach out to this number within 24 hrs