Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Percentage of Time the Glucose Level is Above 10 mmol/l
研究概览
简要总结
The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. In addition, safety parameters, pharmacodynamics and AP-related parameters will be acquired.
This study is a multicenter, open-label, randomized, cross-over trial in 12 subjects. The subjects will be randomized to receive either Lyumjev or Humalog® for a 30-day study period and will then switch to the alternate insulin treatment after a wash-out period.
详细描述
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In the current CE-marked AP, Humalog® (Eli Lilly) is used as rapid-acting insulin. Currently, the ultra rapid-acting insulin Lyumjev (Eli Lilly) is available but has not yet been tested in combination with the AP of Inreda. Both are insulin lispro, but additions to the insulin lispro allow the insulin to act faster with a shorter duration. The hypothesis is that the combination of Lyumjev and the reactive AP system can decrease the time that glucose values are above range which can have a positive effect on glucose regulation.
Objectives of the study:
The main objective is to determine the efficacy of Lyumjev in the Inreda AP system. Secondary objectives are to assess safety parameters, differences in pharmacodynamics and AP-related outcomes comparing Lyumjev to Humalog®.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosed with diabetes mellitus type 1;
- •Treated with the Inreda AP system for a minimum of 1 month;
- •Age between 18 and 75 years;
- •Willing and able to sign informed consent.
- •Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:
- •Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months;
- •HbA1c < 97 mmol/mol;
- •BMI < 35 kg/m^2;
- •No use of acetaminophen, as this may influence the sensor glucose measurements.
排除标准
- •Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
- •Pregnancy and/or breastfeeding;
- •Use of oral antidiabetic agents;
- •Insulinoma;
- •Hypersensitivity reactions to Lyumjev or any of the excipients.
研究组 & 干预措施
Lyumjev (insulin lispro)
Administration of Lyumjev for a 30-day study period (dosage and frequency is patient-dependent)
干预措施: Insulin Lispro Cartridge [Lyumjev] (Drug)
Humalog (insulin lispro)
Administration of standard used Humalog for a 30-day study period and 8-day wash-out period located between the two study periods (dosage and frequency is patient-dependent)
干预措施: Insulin Lispro Cartridge (Drug)
结局指标
主要结局
Percentage of Time the Glucose Level is Above 10 mmol/l
时间窗: 25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired
Time the glucose level is above range (\>10 mmol/l) expressed as a percentage (%)
次要结局
- Side Effects of Insulin(68 days (whole study period))
- Pharmacodynamic Parameters: Euglycemia(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Hypoglycemia(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Mean Glucose Value(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Standard Deviation of Glucose Value(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Glycemic Variability (CoV)(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- Pharmacodynamic Parameters: Glycemic Variability (IQR)(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- AP-related Parameters: Daily Insulin Usage (Units)(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- AP-related Parameters: Glucagon Usage(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))
- AP-related Parameters: Algorithm Activity(25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired))