An Open, Multicentre, Prospective, Non-interventional Study of the CE-marked Medical Device GlucoTab in Nursing Homes and Domiciliary Nursing Care, According to Intended Use Without Additional Invasive and Stressful Measures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy - mean percentage of fasting blood glucose in target range
研究概览
简要总结
GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.
It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.
详细描述
GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.
In this study, only the GlucoTab algorithm supported basalinsulin therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care and nursing homes requiring insulin therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly people, willing to be treated with a basal insulin therapy according to the GlucoTab system
- •Informed consent obtained after being advised of the nature of the study
- •Male or female aged ≥ 18 years
- •Type 2 diabetes (treated with insulin therapy)
- •Residents of participating nursing homes/domiciliary nursing care in the region of Camp de Tarragona (Spain).
排除标准
- •type 1 diabetes mellitus
- •intravenous insulin therapy
- •hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
- •continuous subcutaneous insulin infusion
- •gestational diabetes or pregnancy
- •known or suspected allergy to insulin
- •total parenteral nutrition
- •any mental condition rendering the patient incapable of giving his/her consent
- •any disease or condition which according to the investigator would interfere with the trial or the safety of the patient
结局指标
主要结局
Efficacy - mean percentage of fasting blood glucose in target range
时间窗: ≥ 24 hours after start of the therapy by using the GlucoTab system
Efficacy is assessed by evaluating the Mean percentage of Fasting Blood Glucose in the target range 80 - 180 mg/dl
次要结局
- Usability(at the end of the study, on average three months)
- Safety - number of hypoglycaemic events(at the end of the study, on average three months)
- Efficacy - mean pre-breakfast blood glucose(at the end of the study, on average three months)