NCT03020264终止不适用
Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 161
- 试验地点
- 7
- 主要终点
- Number of confirmed or severe hypoglycemia
研究概览
简要总结
Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in France.
Currently the investigators are seeing an aging of the population explained by the increase in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the frequency of hypoglycemia in older vulnerable patients remains poorly characterized
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 75 years of age;
- •Type 2 diabetes for at least 1 year and treated with insulin for at least 6 months;
- •Treated with basal insulin (ie glargine U100: Lantus®, Abasaglar®, glargine U300: Toujeo®, detemir: levemir®, NPH), premix (ie Novomix® and Humalog Mix®), and / Insulin associated or not with one or more oral and / or injectable antidiabetic agents (analog of GLP1...);
- •Benefiting from at least 1 capillary glucose per day (carried out by the patient himself or a caregiver);
- •Benefiting from a standardized geriatric assessment;
- •Signature of informed consent
- •Patient benefiting from a social security system.
排除标准
- •Male or female aged <75 years;
- •Person without diabetes or type 1 diabetes;
- •Patient treated only lifestyle modifications and / or oral anti-diabetic drugs and / or GLP-1 receptor agonists alone;
- •Subjects with secondary or corticosteroid-induced diabetes;
- •Refusal to participate in the study or inability to collect consent;
- •Patient for whom follow-up of the study procedures is impossible (glycemic record impossible or insufficient);
- •Patient not eligible for geriatric assessment;
- •Patient already participating in another study;
- •Patient with a severe pathology limiting his life expectancy (palliative care ...) compromising his participation in the study at the discretion of the investigator;
- •Patient benefiting from a safeguard of justice.
研究组 & 干预措施
Patients older than 75 years
Experimental
Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro
干预措施: glycemic sensor FREESTYLE Libre Pro (Device)
结局指标
主要结局
Number of confirmed or severe hypoglycemia
时间窗: 1 month
Percentage of patients with at least one episode of confirmed and / or severe hypoglycaemia by measuring capillary blood glucose during 4 weeks of prospective follow-up.
次要结局
- Number of confirmed and severe hypoglycaemia in patients with type 2 diabetes aged 75 years and older in "vigorous" and "vulnerable" subgroups of patients according to a geriatric assessment score(1 month)
- Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia(1 month)
- Number of hypoglycaemia in elderly patients admitted to EHPAD(1 month)
- Score for fear of hypoglycemia in elderly diabetic patients(1 month)
- Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)(1 month)
- number of events / patient / month of severe hypoglycemia(1 month)
- Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold)(1 month)
- Number of hospitalizations due to hypoglycemia(1 month)
- Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)(1 month)
- Number of the transition to ER due to hypoglycemia(1 month)
- Number of falls due to hypoglycemia(1 month)
- Number of death due to hypoglycemia(1 month)
研究者
研究点 (7)
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