Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Time in glycemic range 70-180 mg/dl
研究概览
简要总结
Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.
详细描述
New algorithms for the automation of insulin delivery (AID) are showing great benefit on glucose control in people with type 1 diabetes. Indeed, Hybrid closed loop (HCL) systems can improve HbA1c levels, percentage of time in defined glucose range, time below range and time over range, according to RCT and observational studies results. However, scientific evidences demonstrating potential benefits on the reduction of diabetes complications are limited regarding CSII or SAP with demonstrated reduction of cardiovascular mortality, improvement of albuminuria and peripheral nerve damage.
Data on AID effects on complications of diabetes are missing. In this study intermediate damage markers will be measured to assess potential effects of AID in comparison to sensor augmented pumps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male and female patients
- •T1D patients above 18 years in CSII treatment for at least 3 months
- •HbA1c values between 6.0% and 9.5%
- •Disease duration ≥ 2 years
- •Written informed consent obtained from the patient
排除标准
- •Pregnancy
- •Participation to other clinical trials
- •A history of alcohol or drug abuse
- •Advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or eGFR < 60 ml/min/1,73m2
- •Proliferative Diabetic retinopathy or macular edema
- •Established Atherosclerotic Cardiovascular Disease (ASCVD) or history of heart failure
- •Presence of serious diseases or conditions which in the opinion of the Investigator makes patient non-eligible for the study
- •Hypoglycemia Unawareness (Clarke score > 4)
- •Patients unable to understand spoken and written Italian language
研究组 & 干预措施
Study Group A (Intervention)
Group treated with automated insulin delivery (advanced hybrid closed-loop)
干预措施: Medtronic MiniMed 780G with SmartGuard activation (Device)
Study Group B (Control)
Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)
干预措施: Medtronic MiniMed 780G without SmartGuard activation (Device)
结局指标
主要结局
Time in glycemic range 70-180 mg/dl
时间窗: From Baseline to 26 weeks
time spent by the patient in glucose range
Glycated Hemoglobin (HbA1c)
时间窗: From Baseline to 26 weeks
percentage of hemoglobin glycosylated
次要结局
- Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin(From Baseline to 26 weeks)
- Early microangiopathic damage markers: osteopontin(From Baseline to 26 weeks)
- Early microangiopathic damage markers: vWF levels(From Baseline to 26 weeks)
- Early microangiopathic damage markers: sTNFR-1/2(From Baseline to 26 weeks)
- Early microangiopathic damage markers: B-2 microglobulin(From Baseline to 26 weeks)
- Early microangiopathic damage markers: cystatin C(From Baseline to 26 weeks)
- Endothelial disfunction(From Baseline to 26 weeks)
研究者
Paolo Fiorina, MD
MD, Ph.D, Full Professor
University of Milan