Assessing the Benefits of a Painless Lancing Device Among Diabetes Subjects in Improving Self-monitoring Frequency and HbA1c
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percentage SMBG adherence
研究概览
简要总结
The purpose of this study is to assess the benefits of a painless lancing device among diabetes subjects in improving self-monitoring frequency and HbA1c compared to the conventional lancing device.
详细描述
Self-monitoring of glucose forms the cornerstone of diabetes management. There are multiple limiting factors towards efficient self- monitoring of blood glucose, including cost barriers, inconvenience, investment of time, pain associated with pricking etc. Pain has perceived as a major impediment to the self-monitoring of blood glucose.
Genteel lancing device offers a painless pricking experience and hence helps to report blood sugar values at least 4 times a day. The perceived pain sensitivity of the study subjects would be assessed using the 4- point pain screening questionnaire during the course of the study.
The aim of this study is to gather information on the percentage reduction in HbA1c values in diabetes patients as compared to the baseline values after three months and six months respectively brought about by percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period. SMBG adherence = actual number of fingerpricks (6 times daily in type 1 subjects or twice weekly in type 2 subjects).
SMBG adherence can be provisionally attained by multiple pricking using painless Genteel lancing device compared to the conventional lancing device. Additionally, the subject is asked about the likelihood they would use the device if available for routine SMBG practice in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 70 years of age. If minor (<18 years), accompanied by caretaker.
- •Diagnosed with either Type 1 or Type 2 diabetes including newly diagnosed. 50% of the study participants will be type 1 diabetes subjects and 50% will be type 2 diabetes subjects
- •Presenting with an uncontrolled glycemic status (HbA1c >8.0%).
- •Ready for Self-Monitoring of Blood Glucose (SMBG) practices.
- •Attending physician prescribed testing at least 2 times per day
- •Judged by the study trainer to be competent to correctly use Genteel AND demonstrated to the trainer that the subject can use the Genteel device properly.
排除标准
- •More than 70 years and less than 5 years
- •HbA1c < 8.0%
- •Unwilling for SMBG.
研究组 & 干预措施
Genteel arm
In the Genteel arm, the subjects exclusively use the Genteel device for the first 12 weeks, and then switch to the conventional method of SMBG for an additional 12 weeks. This arm will use Butterfly Touch Lancets (BTL) throughout the study.
干预措施: Genteel lancing device (Device)
Genteel arm
In the Genteel arm, the subjects exclusively use the Genteel device for the first 12 weeks, and then switch to the conventional method of SMBG for an additional 12 weeks. This arm will use Butterfly Touch Lancets (BTL) throughout the study.
干预措施: Conventional lancing device (Device)
Conventional arm
In the Conventional arm, the subjects use the conventional method of SMBG for the first 12 weeks and then switch to the Genteel device for an additional 12 weeks. This arm will use the lancet and lancing device which they were using prior to randomization to the study.
干预措施: Genteel lancing device (Device)
Conventional arm
In the Conventional arm, the subjects use the conventional method of SMBG for the first 12 weeks and then switch to the Genteel device for an additional 12 weeks. This arm will use the lancet and lancing device which they were using prior to randomization to the study.
干预措施: Conventional lancing device (Device)
结局指标
主要结局
Percentage SMBG adherence
时间窗: 24 weeks
Percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period.SMBG adherence = actual number of fingerpricks/ ideal number of fingerpricks(6 times daily in type 1 subjects or twice weekly in type 2 subjects). Should be assessed both at baseline and end of 24 weeks.
Percentage reduction in HbA1c
时间窗: 24 weeks
2) Percentage reduction in the HbA1c values as compared to the baseline values at 12 weeks and 24 weeks.
次要结局
- Subjective assessment of pain reduction after using Genteel(24 weeks)
- Subjective assessment of probability of using Genteel for SMBG(24 weeks)
研究者
Dr. Jothydev Kesavadev
Chief Diabetologist and Chairman
Jothydev's Diabetes and Research Centre