The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- difference in change in urine albumine excretion from baseline to end of study (12 months)
研究概览
简要总结
The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes
详细描述
80 type 1 diabetic patients with kidney function (GFR > 45 ml/min), but with urine albumin excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the study.
Before the study is initiated all patients receive education in intensive diabetes treatment and self-care including carbohydrate counting.
Patients return to the clinic after 1,3,6,9, and 12 months for measurement of urine albumine excretion, clinical examination including blood pressure, CGM sensor readings, four-point self monitored blood glucose (SMBG) profiles, blood samples and fulfillment of questionnaire to assess quality of life. At entry and after 12 months, eye fundus foto, 24-hour blood pressure, GFR, and carotis intima media thickness (CIMT)are also evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age,
- •Type 1 diabetes according to WHO criteria,
- •Urin albumine > 30 mg/g (albumine/creatinine ratio),
- •HbA1c > 7.5 < 13.0%,
- •No change in RAAS blocking treatment at least 4 weeks prior to screening.
排除标准
- •Kidney disease other that diabetic nephropathy,
- •Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
- •Use of insulin pump within 12 months,
- •Acute myocardial infarction within 3 months,
- •Severe arteriosclerosis as judged by the investigator,
- •Heart failure (NYHA class 3 or 4),
- •Abuse of alcohol or drugs,
- •Any cancer diagnosis unless in remission at least 5 years prior to screening,
- •Participation in other intervention studies,
- •Pregnant or lactating women,
- •Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.
结局指标
主要结局
difference in change in urine albumine excretion from baseline to end of study (12 months)
时间窗: 12 months
Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
次要结局
- difference in endothelial cell dysfunction(12 months)
- difference in change of glomerular filtration rate (GFR)(12 months)
- difference in the occurence or progression of retinopathy(12 months)
- difference in change of HbA1c from baseline to 12 months(12 months)
- difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles(12 months)
- difference in change of 24-hour blood pressure(12 months)
- difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP(12 months)
- difference in carotid intima media thickness (CIMT)(12 months)
研究者
Steen Andersen
Chief physician, DMSc
Steno Diabetes Center Copenhagen