Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
lancing device, lancet
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.
Interventions
OTHERLancing depth setting (1)
The lowest depth setting (1)
OTHERLancing depth setting (5)
The highest depth setting (5)
DEVICE28 G lancet
Droplet 28 G
DEVICE30 G lancet
Droplet personal lancet 30 G
DEVICE33 G lancet
Droplet personal lancet 33 G
DEVICELancing device A
Glucoject Dual Plus lancing device
DEVICELancing device B
Droplet lancing device
DEVICELancing device C
Commercially available lancing device
Sponsors
Medical University of Lodz
HTL-Strefa S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Poland
Outcome results
None listed