Status:
COMPLETED
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
Lead Sponsor:
HTL-Strefa S.A.
Collaborating Sponsors:
Medical University of Lodz
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-50 years
Phase:
NA
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 maximu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03479619
Start Date
March 6 2018
End Date
September 27 2018
Last Update
February 5 2020
Active Locations (1)
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1
Nzoz Magmed
Lodz, Poland, 91-738