Basal Study - Observational Multicentric Clinical Study: Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,036
- 主要终点
- basal/total ratio
研究概览
简要总结
Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2 (T2) on basal-bolus regimen, by investigating whether there is a relationship with HbA1c and episodes of hypoglycemia.
详细描述
The study was commissioned by the Italian Association of Clinical Endocrinologists (Associazione Medici Endocrinologi - AME) and approved by the Ethical Committee of Cuneo Hospital (BASAL Study- OSS 001/2016 - rif ENDO 30). The research was open to all specialists taking care of patients with diabetes in Italy.
The primary endpoint was glycemic control, evaluated by HbA1c levels, according to b/T.
Secondary endpoints were occurrence of major hypoglycemic episodes according to b/T; differences between patients with T1 and T2.
An ad hoc form was developed and used to record all medical findings. The form was emailed to all participating centers who then emailed or faxed it back to our data manager. Data were checked for accuracy.
The following data were required: age, gender, body weight and height, country of origin, type of diabetes and its duration, units of basal and total (basal plus prandial) daily insulin, type of basal insulin (Glargine, Detemir or Degludec), use and dosage of metformin, and number of major hypoglycemic episodes (<40 mg/dL or requiring caregivers intervention) in the last three months. Serum creatinine and HbA1c levels obtained within the previous two months were also required.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult outpatients (≥20 and ≤80 years);
- •T1 or T2 diabetes mellitus;
- •basal-bolus insulin regimen (basal insulin, i.e. Glargine, Detemir or Degludec, plus at least two prandial insulin shots) for at least six months;
- •assuming three daily meals;
- •capable of informed consent.
排除标准
- •pregnancy;
- •breast-feeding;
- •severe liver or renal failure (eGFR <30 mL/min/1.73 m2);
- •use of OADs (except for metformin);
- •hospitalization for any cause in the last six month;
- •glucocorticoid treatment in the last six month;
- •oncologic treatment in the last six month;
- •Ramadan in the last six months.
结局指标
主要结局
basal/total ratio
时间窗: last six month
To evaluate the basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2 (T2) on basal-bolus regimen
次要结局
- glycaemic control(last six month)
- hypoglycemia(last six month)