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

HTL-Strefa

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Other: Lancing depth setting (1); Device: 30 G lancet; Device: Lancing device C; Device: Lancing device A; Device: Lancing device B; Device: 28 G lancet; Device: 33 G lancet; Other: Lancing depth setting (5)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03479619

010617

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 18 patient groups

A/28/1

Experimental group

Description:

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

Treatment:

Device: 28 G lancet

Other: Lancing depth setting (1)

Device: Lancing device A

A/28/5

Experimental group

Description:

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

Treatment:

Device: 28 G lancet

Other: Lancing depth setting (5)

Device: Lancing device A

A/30/1

Experimental group

Description:

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

Treatment:

Other: Lancing depth setting (1)

Device: 30 G lancet

Device: Lancing device A

A/30/5

Experimental group

Description:

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

Treatment:

Other: Lancing depth setting (5)

Device: 30 G lancet

Device: Lancing device A

A/33/1

Experimental group

Description:

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

Treatment:

Other: Lancing depth setting (1)

Device: Lancing device A

Device: 33 G lancet

A/33/5

Experimental group

Description:

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

Treatment:

Other: Lancing depth setting (5)

Device: Lancing device A

Device: 33 G lancet

B/28/1

Experimental group

Description:

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

Treatment:

Device: 28 G lancet

Device: Lancing device B

Other: Lancing depth setting (1)

B/28/5

Experimental group

Description:

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

Treatment:

Device: 28 G lancet

Other: Lancing depth setting (5)

Device: Lancing device B

B/30/1

Experimental group

Description:

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

Treatment:

Device: Lancing device B

Other: Lancing depth setting (1)

Device: 30 G lancet

B/30/5

Experimental group

Description:

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

Treatment:

Other: Lancing depth setting (5)

Device: Lancing device B

Device: 30 G lancet

B/33/1

Experimental group

Description:

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

Treatment:

Device: Lancing device B

Other: Lancing depth setting (1)

Device: 33 G lancet

B/33/5

Experimental group

Description:

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

Treatment:

Other: Lancing depth setting (5)

Device: Lancing device B

Device: 33 G lancet

C/28/1

Experimental group

Description:

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

Treatment:

Device: 28 G lancet

Device: Lancing device C

Other: Lancing depth setting (1)

C/28/5

Experimental group

Description:

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

Treatment:

Device: 28 G lancet

Device: Lancing device C

Other: Lancing depth setting (5)

C/30/1

Experimental group

Description:

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

Treatment:

Device: Lancing device C

Other: Lancing depth setting (1)

Device: 30 G lancet

C/30/5

Experimental group

Description:

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

Treatment:

Device: Lancing device C

Other: Lancing depth setting (5)

Device: 30 G lancet

C/33/1

Experimental group

Description:

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

Treatment:

Device: Lancing device C

Other: Lancing depth setting (1)

Device: 33 G lancet

C/33/5

Experimental group

Description:

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

Treatment:

Device: Lancing device C

Other: Lancing depth setting (5)

Device: 33 G lancet