A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test".
详细描述
A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test". Each subject will be randomly selected into one of two groups, group "A" and group "B". Forty (40) type I subjects who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
During the inpatient phase subjects will have standardized breakfast and dinner and venous blood samples will be taken for insulin and blood glucose measurements. Comparison of the two days ("control" and "test") will enable us to evaluate the effect of the device on post prandial glucose levels and insulin levels.
During the outpatient (daily life) phase subjects will be required to perform at least 5 self blood glucose measurements (SMBG), three before each meal and two at 90 minutes post breakfast and dinner. Comparing the SMBG measurement from the two periods will enable us to evaluate the effect of the device on post prandial glucose levels. The subjects will be contacted over the phone by the study staff to verify compliance with the protocol.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 to 70 years (values included)
- •Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ≥ 0.7 units per kg bodyweight.
- •6% ≤ HbA1c ≤ 9.5%
- •Use of short-acting prandial insulin analogues with injections
- •Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book.
- •Willing to sign informed consent
排除标准
- •Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
- •Known gastro- or enteroparesis.
- •Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start.
- •Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
- •Hypoglycaemia unawareness (Score > 4 in the Hypoglycaemia Awareness Questionnaire, see appendix)
- •Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
- •Any known life-threatening disease
- •Pregnant women, lactating women or women who intend to become pregnant during the observation period
- •Any other condition or compliance issues that might interfere with study participation or results
- •Subjects with heat sensitivity
- •Subjects involved in or planed to participate in other studies
- •Subjects who are incapable of contracting or under guardianship
结局指标
主要结局
efficacy
时间窗: 2 hours
AUC120 BG (area under the curve of postprandial glucose change 2 hours after meal) after breakfast and dinner under standardized conditions during the inpatient phase.
次要结局
- Safety(14 weeks)
- Efficacy(8 weeks)
- Satisfaction(14 weeks)