The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus

NCT04253431 | Completed

• 1 other identifier: mp08.13
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized single-blind study with the use of different lancing devices equipped with personal lancets to determine and to compare the amount of capillary blood volume and perceived pain after a single lancing of the fingertip.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

lancing device; lancet; fingerprick; capillary blood; self-monitoring of blood glucose

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 different lancing devices set to maximum puncture depth, with the use of various-sized personal lancets (28G and 33G).

  The blood from the puncture site was collected to the capillaries for 30 seconds, and afterwards amount of the blood was measured using a calibrated ruler

Secondary Outcomes (1)

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

  3 minutes (+/- 1 minute) after lancing

Study Arms (10)

L01

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: Droplet lancing device (HTL-Strefa S.A.); Device: Ultra-Fine 33G lancets (BD)

L02

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: Microlet 2 lancing device (Bayer); Device: Droplet 33G lancets (HTL-Strefa S.A.)

L03

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: OneTouch Delicia lancing device (LifeScan); Device: OneTouch Delicia Extra Fine 33G lancets (LifeScan)

L04

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: Droplet lancing device (HTL-Strefa S.A.); Device: HaemoFine 33G lancets (HTL-Strefa S.A.)

L05

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: ReliOn lancing device (ReliOn); Device: ReliOn Ultra-Thin Plus 33G lancets (ReliOn)

L06

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: Accu-Chek Softclix lancing device (Roche); Device: Softclix 28 G lancets (Roche)

L07

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: Microlet 2 lancing device (Bayer); Device: Microlet 28G lancets (Bayer)

L08

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: Droplet lancing device (HTL-Strefa S.A.); Device: Droplet 33G lancets (HTL-Strefa S.A.)

L09

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: BGStar lancing device (Sanofi Aventis); Device: BGStar Ultra-Thin 33G lancets (Sanofi Aventis)

L10

EXPERIMENTAL

Finger pricking using lancing device with personal lancets

Device: HaemoFine 33G lancets (HTL-Strefa S.A.); Device: GlucoJect Dual S lancing device (Menarini)

Interventions

Droplet lancing device (HTL-Strefa S.A.) DEVICE

L01; L04; L08

Microlet 2 lancing device (Bayer) DEVICE

L02; L07

OneTouch Delicia lancing device (LifeScan) DEVICE

L03

ReliOn lancing device (ReliOn) DEVICE

L05

Accu-Chek Softclix lancing device (Roche) DEVICE

L06

BGStar lancing device (Sanofi Aventis) DEVICE

L09

Ultra-Fine 33G lancets (BD) DEVICE

L01

Droplet 33G lancets (HTL-Strefa S.A.) DEVICE

L02; L08

OneTouch Delicia Extra Fine 33G lancets (LifeScan) DEVICE

L03

HaemoFine 33G lancets (HTL-Strefa S.A.) DEVICE

L04; L10

Softclix 28 G lancets (Roche) DEVICE

L06

ReliOn Ultra-Thin Plus 33G lancets (ReliOn) DEVICE

L05

GlucoJect Dual S lancing device (Menarini) DEVICE

L10

Microlet 28G lancets (Bayer) DEVICE

L07

BGStar Ultra-Thin 33G lancets (Sanofi Aventis) DEVICE

L09

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the informed consent.
• Must currently be diagnosed with either Type I or Type II diabetes mellitus.
• Otherwise in good physical and mental health.
• Must currently be performing self-monitoring of blood glucose (self reported).
• Must be between 18-75 years of age (inclusive).
• Ability to read and follow study instructions.

You may not qualify if:

• Pregnancy (self reported).
• Severe poor blood circulation in the fingers.
• Any skin condition on his or her fingers that prevents blood sampling.
• History of a bleeding disorder.
• Neuropathy or other condition affecting sensation in the hands.
• Self-reported blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
• Currently participating in another study.
• History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
• Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
• Any prescription or OTC medication within two days of starting the study which might affect pain perception (for example, ibuprofen or paracetamol).
• Alcohol 48 hours before study start.

Sponsors & Collaborators

• HTL-Strefa S.A.: lead

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 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: January 31, 2020
• First Posted: February 5, 2020
• Study Start: August 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 5, 2020

Record last verified: 2018-08