NCT02994277已完成不适用
Pilot Study of Automatic Glycaemic Correction Systems (Closed-loop) in Patients With Type 1 Diabetes Mellitus With Continuous Subcutaneous Insulin Infusion
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- System connectivity
研究概览
简要总结
The purpose of this study is to use closed-loop systems with the algorithms designed by the University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).
详细描述
Aims:
- To test University of Virginia closed-loop algorithm with meal announcement for 36 hours at our facilities.
- To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm without meal announcement to maintain glucose control for 2 periods of 12 hours
In both cases, the adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time .
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient have been diagnosed with T1DM at least two years ago and have been using an insulin pump and a CGM for at least 6 months prior to the trial first visit.
- •Patient is >18 and <65 years.
- •Patient has HbA1c > 6.5 % and < 10%.
- •Woman in premenopausal age agrees to use contraceptive methods.
- •Woman in premenopausal age has negative B-HCG in the tests performed in the trial.
- •Patient is trained in carbohydrates counting.
- •Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits.
排除标准
- •Patient has been hospitalized for diabetic ketoacidosis in the last 12 months.
- •Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months.
- •Patient has a history of coronary disease or cardiac failure.
- •Patient with uncontrolled arterial hypertension.
- •Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia.
- •Patient has symptoms compatible with an active infectious disease.
- •Patient has Cystic Fibrosis.
- •Pregnant women, or women with the intention of getting pregnant; women breastfeeding.
- •Patient has been hospitalized for psychiatric treatment in the last 6 months.
- •Patient with a diagnosis of an adrenal disease.
- •Patient has abnormal laboratory values for liver function: transaminase > 2x upper limit of normal.
- •Patient has abnormal laboratory values for renal function: GFR < 60 ml/min/1.73m2
- •Patient has active gastroparesis.
- •Patient is under oncological treatment.
- •Patient has taken acetaminophen 72 hours previous to the study.
研究组 & 干预措施
UVa and ITBA/UNLP algorithm arm
Experimental
To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm
干预措施: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm (Device)
结局指标
主要结局
System connectivity
时间窗: 36 hours
Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.
次要结局
- Number of all hypoglycaemic events (syntomatic and non syntomatic)(36 hours)
- Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial(36 hours)
- Meal composition's effect in the efficacy of the system to control glycaemia(36 hours)
- Technical fail rate(36 hours)
- Percentage of time in glycaemia between 70-180 mg/dl(36 hours)
- Percentage of time in glycaemia between 181-250 mg/dl(36 hours)
- Percentage of time in hypoglycaemia defined as <70 mg/dl(36 hours)
- Percentage of time in hyperglycaemia defined as >180 mg/dl(36 hours)
研究者
Waldo Horacio Belloso
MD
Hospital Italiano de Buenos Aires
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