Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Mean plasma glucose level measured 3 times just before the first hemodialysis session
研究概览
简要总结
The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes
详细描述
We conducted a pilot prospective multicenter study in five French centers (Strasbourg University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.
All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. The CGM was continued during the next dialysis session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. The probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. Due to the time required for CGM calibration, plasma glucose levels were only partially recorded during the first dialysis session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 83 years
- •diagnosis of type 1 or type 2 diabetes
- •treatment with insulin injections or oral hypoglycemic agents
- •HbA1c ≥ 7% (i.e., 53 mmol/mol)
- •on hemodialysis for more than three months
排除标准
- •unstable anemia or blood transfusions within the two months prior to the beginning of the study
- •a life expectancy of less than 1 year
- •chronic inflammatory disease
- •evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
- •noncompliant patients
研究组 & 干预措施
Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
干预措施: Basal-bolus detemir-aspart insulin regimen (Drug)
结局指标
主要结局
Mean plasma glucose level measured 3 times just before the first hemodialysis session
时间窗: Baseline and at 3 months of treatment
Determination by the glucose dehydrogenase method
次要结局
- HbA1c(Baseline and at 3 months of treatment)
- Body weight(Baseline and at 1 month and 3 months of treatment)
- Insulin requirements(Baseline and at 1 month and 3 months of treatment)
- Symptomatic hypoglycemia(Baseline and at 1 month and 3 months of treatment)
- Continuous glucose monitoring parameters(Baseline and at 1 month and 3 months of treatment)
- Deaths and major cardiovascular events(Baseline and at 3 months of treatment)