A Single-blind, Randomized, Single-centre Study to Investigate the Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Volume (uL) of blood in the capillary tube
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
L01
Finger pricking using lancing device with personal lancets
干预措施: Droplet lancing device (HTL-Strefa S.A.) (Device)
L01
Finger pricking using lancing device with personal lancets
干预措施: Ultra-Fine 33G lancets (BD) (Device)
L02
Finger pricking using lancing device with personal lancets
干预措施: Microlet 2 lancing device (Bayer) (Device)
L02
Finger pricking using lancing device with personal lancets
干预措施: Droplet 33G lancets (HTL-Strefa S.A.) (Device)
L03
Finger pricking using lancing device with personal lancets
干预措施: OneTouch Delicia lancing device (LifeScan) (Device)
L03
Finger pricking using lancing device with personal lancets
干预措施: OneTouch Delicia Extra Fine 33G lancets (LifeScan) (Device)
L04
Finger pricking using lancing device with personal lancets
干预措施: Droplet lancing device (HTL-Strefa S.A.) (Device)
L04
Finger pricking using lancing device with personal lancets
干预措施: HaemoFine 33G lancets (HTL-Strefa S.A.) (Device)
L05
Finger pricking using lancing device with personal lancets
干预措施: ReliOn lancing device (ReliOn) (Device)
L05
Finger pricking using lancing device with personal lancets
干预措施: ReliOn Ultra-Thin Plus 33G lancets (ReliOn) (Device)
L06
Finger pricking using lancing device with personal lancets
干预措施: Accu-Chek Softclix lancing device (Roche) (Device)
L06
Finger pricking using lancing device with personal lancets
干预措施: Softclix 28 G lancets (Roche) (Device)
L07
Finger pricking using lancing device with personal lancets
干预措施: Microlet 2 lancing device (Bayer) (Device)
L07
Finger pricking using lancing device with personal lancets
干预措施: Microlet 28G lancets (Bayer) (Device)
L08
Finger pricking using lancing device with personal lancets
干预措施: Droplet lancing device (HTL-Strefa S.A.) (Device)
L08
Finger pricking using lancing device with personal lancets
干预措施: Droplet 33G lancets (HTL-Strefa S.A.) (Device)
L09
Finger pricking using lancing device with personal lancets
干预措施: BGStar lancing device (Sanofi Aventis) (Device)
L09
Finger pricking using lancing device with personal lancets
干预措施: BGStar Ultra-Thin 33G lancets (Sanofi Aventis) (Device)
L10
Finger pricking using lancing device with personal lancets
干预措施: HaemoFine 33G lancets (HTL-Strefa S.A.) (Device)
L10
Finger pricking using lancing device with personal lancets
干预措施: GlucoJect Dual S lancing device (Menarini) (Device)
结局指标
主要结局
Volume (uL) of blood in the capillary tube
时间窗: 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
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).
次要结局
- The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).(3 minutes (+/- 1 minute) after lancing)