NCT04042207已完成不适用
In Adults With Very Unstable Type 1 Diabetes, is the DBLHU Closed-Loop Insulin Delivery System Able to Improve Blood Glycemic Control Compared to Low-Glucose-Predictive-Suspend System: Two-center, Randomized, Open-label Study
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年9月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods for the third and fourth week for each treatment period
研究概览
简要总结
Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period.
A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session.
An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (aged 22 or more) with Type 1 diabetes for at least 5 years and confirmed C peptide negative
- •Treated with continuous subcutaneous insulin infusion (CSII) for ≥ 6 months,
- •Trained to carbohydrate counting/flexible insulin therapy,
- •Subject that had experienced, despite optimal diabetes management and prior to any equipment with Smartguard technology, glucose instability as defined by at least 2 of the following criteria which would have led to eligibility for pancreatic islet transplantation:
- •occurrence of at least 1 severe hypoglycemic episode during the past 12 months (need for third party),
- •occurrence of ketoacidosis (hospitalization in ICU) without explanation
- •Impaired awareness of hypoglycemia (Clark Score ≥ 4; Gold Score > 4)
- •glucose levels: standard deviation > 50% of the arithmetic mean value on glucose meter or > 40 mg/dl on CGM on a 14-day recording
- •glucose levels: MAGE (mean amplitude of glucose excursions) index > 60 mg/dl
- •glucose levels: coefficient of variation (CV) > 36%
- •with persisting extreme glucose variability despite optimal medical care
- •with contra-indication or no agreement to undertake pancreatic islet transplantation or pancreas transplantation.
- •Subject willing to wear the DBLHU system continuously throughout the study
排除标准
- •patient with type 2 diabetes
- •age < 22 years old
- •patient without any social or familial support able to intervene in case of severe hypoglycemic event
- •any permanent and severe condition able to interact with the normal course of the study
- •patient with insulin-resistance defined by insulin requirements > 1.5U/kg/d
- •patient with a daily dose of insulin required greater than 90 units
- •patient receiving a total daily dose of insulin less than 8 U
- •use of any insulin that is not 100 U/mL fast-acting insulin analog
- •patient suffering from a serious illness or a treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment of steroids)
- •patient having severe problems of uncorrected hearing and/or visual acuity
- •patient who is unable to understand and perform all the instructions provided by Diabeloop SA
- •patient not willing to perform ≥4 finger stick blood glucose measurements daily
- •patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
- •patient who has had a pancreatectomy or who has pancreatic malfunctions
- •patient having severely altered renal function (Creatinine clearance < 30ml/min)
- •patient on dialysis
- •pregnancy or breast-feeding patient, or project of pregnancy during the next 6 months
- •lack of effective contraception in women of childbearing potential
- •all conditions excluding participation to clinical research as defined in France
结局指标
主要结局
Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods for the third and fourth week for each treatment period
时间窗: 14 days for each treatment period
Measured by continuous glucose monitoring
次要结局
- Average glycemia level(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Estimated HbA1c (eHbA1c) levels / glucose management indicator (GMI)(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Number of severe hypoglycemia with loss of consciousness(During 4 weeks of each treatment period and during 24-week and 48-week extension period)
- For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia(after baseline period (2-week); after crossover period; after 24-week and after 48-week extension period)
- Evolution over time of the DBLHU system's performance on a day-to-day and determination of the optimization delay of glycemic control(Over twenty-four hour periods on the four weeks of each treatment period and of the 24-week and 48-week extented CL period.)
- Percent of CGM time in glucose range 70-180 mg/dl during nighttime.(Overnight (defined as 00:00 to 06:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Percent of CGM time with glucose > 180mg/dl, > 250mg/dl, > 300mg/dl and > 360mg/dl(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- HbA1c levels(HbA1c value at the week 24 and week 48 of extented CL period.)
- Percent of CGM time in glucose range 70-180 mg/dl during daytime.(Over daytime (defined as 06:00 to 00:00) periods on the third and fourth week of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Comparison of MAGE index and Low Blood Glucose Index (LBGI)(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during 24-week extension period)
- Number of hospitalizations for severe hypoglycemia or ketoacidosis(During 4 weeks of each treatment period and during 24-week and 48-week extension period)
- Percentage of CGM time in glucose range 70-180 mg/dl, during 24 hours periods(24-week and 48-week extension period)
- Percent of CGM time with glucose < 70mg/dl, < 60mg/dl, < 54mg/dl and < 50mg/dl(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Rate of CGM excursions below 54 mg/dl (3.0 mM) for at least 15 min(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Glucose coefficient of variation (CV) and Standard deviation (SD)(Over twenty-four hour periods on the third and fourth weeks of each treatment period and during the last 4 weeks of the 24-week and 48-week extented CL period.)
- Number of acute metabolic events (severe hypoglycemia, severe Diabetic Ketoacidosis [DKA])(During 4 weeks of each treatment period and during 24-week and 48-week extension period)
研究者
研究点 (4)
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