Evaluation of Blood Volume and Perceived Pain During Fingerstick Monitoring of Blood Glucose When Using Different Currently Marketed Lancing Devices and Lancets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- Blood Sample of Sufficient Volume to Yield a Valid Meter Reading
研究概览
简要总结
The procurement of blood for SMBG, usually via a finger stick, is considered by many patients to be the most painful portion of diabetes therapy. This has led to the marketing of smaller gauge lancets, lancing devices with variable depth settings and blood glucose sensors that require less blood for measurement.
In this study, two main outcomes were evaluated: The first, which was assessed at Visit 1, was whether specific combinations of lancets and lancing devices would yield sufficient blood volume to allow valid assessment of diabetic subjects' glucose levels. The other outcome, assessed at Visit 2, was the level of pain perceived by subjects during lancing with specific combinations of lancets and lancing devices. During Visit 2, pain assessment was done using a Visual Analog Scale and such that for each lancet/lancing device, the lowest lancing device setting that yielded a valid BG reading for each subject during Visit 1 was used. A third outcome measure, overall comfort with lancing, was also assessed at Visit 2.
A total of 5 combinations of lancets and lancing devices were evaluated.
These were as follows:
- BD/33G = BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
- OTM/33G =OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
- OTM/28G =OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
- OTU/28G = OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips)
- ACC/28G= Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip)
After enrollment and qualification, subjects were assigned to one of 4 intervention arms. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to each arm are shown in the Assigned Interventions Table below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must currently be diagnosed with either Type I or Type II diabetes mellitus.
- •Must currently be performing self monitoring of blood glucose
- •Must be between 18-70 years of age (inclusive).
- •Must be able to read and follow study instructions in English.
排除标准
- •Pregnant (self reported)
- •History of poor blood circulation.
- •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 [non A, non B], syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
- •Currently participating in another study
- •Employed by BD, J&J, Roche or the Clinical Site.
结局指标
主要结局
Blood Sample of Sufficient Volume to Yield a Valid Meter Reading
时间窗: Study Day 1 (Visit 1)
Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.
Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)
时间窗: Approximately Day 3 (Visit 2)
In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.
次要结局
- Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)(Approximately Day 3 (Visit 2))
- Reported Device Preference Within Lancing Pair at Visit 2(Approximately Day 3 (Visit 2))