Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), using an external pump, could be a solution to improve diabetes control.
The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c>7 -10%).
详细描述
Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent signature and randomisation (group CSII or MDI). Patients randomised in the CSII group are instructed to use pump between V2 and V3.
Visit 3: 5-day's hospitalisation. Start of CSII or MDI treatments. Stop of all oral diabetic medications except for metformin, which is followed up until the end of the study. Teaching program on diabetes management (diet, physical activity and self-adjustment of insulin doses). HbA1c, clinical and biological parameters. Questionnaires.
Follow-up visits 4-7 (1, 3, 6, 9 months): HbA1c. Treatment adjustment. Adverse events collection.
Final visit (12 months): HbA1c, clinical and biological parameters. Questionnaires. Adverse events collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 diabetes mellitus
- •Age > 18 years
- •Patients treated for at least 6 months by Multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection -Glargine or Detemir- or at least 2 NPH insulin injections) plus mealtimes rapid acting insulin injections (Human or analogs) +/- oral hypoglycemic agents.
- •7,5% ≤ HbA1c ≤ 10%
- •Patients able to perform self-monitoring blood glucose (SMBG) measurement and insulin injections.
- •SMBG > 3/day
排除标准
- •Diabetic retinopathy contraindicating glycemic control intensification
- •Situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency...)
- •Situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, ...)
- •Recent (<3 month) serious pathology
- •Planned treatment or therapy able to induce long-term glycemic control worsening
- •Long lasting (> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol
- •Pregnancy wish or ongoing pregnancy
- •Known Haemoglobinopathy.
- •Creatinin clearance <30ml/min (MDRD formula).
- •Organ transplant.
研究组 & 干预措施
PPE
PPE : CSII +/- Metformin.
干预措施: Detemir insulin, Aspart insulin, Metformin (Drug)
injections
INJ: basal/bolus MDI +/- Metformin
干预措施: Detemir insulin, Aspart insulin, Metformin (Drug)
结局指标
主要结局
HbA1c
时间窗: 12 months
次要结局
- Weight, waist perimeter, BP, triglycerides, total cholesterol, HDL and LDL cholesterol ; QOL, physical activity, treatment satisfaction and eating habits questionnaire.(12 months)
- self monitoring blood glucose measurements (frequency, mean and standard deviation, number of hypoglycaemic and hyperglycaemic events)(12 months)