Use of a CMGS to Validate Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Treated With Subcutaneous Continuous Insulin Infusion and Practicing Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of episodes of symptomatic or non-symptomatic hypoglycaemia
研究概览
简要总结
Primary aim:
To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin infusion, adjustment of the recommended basal insulin flow rate in the event of physical activity allows the subjects to practice sports without any increase in incidence of hypoglycaemia during physical activity or the ensuing hours.
(NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance with the EMEA definition).
The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80 percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical activity (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be studied as an option to adjust insulin dosage in the event of unprogrammed physical activity (temporary reduction of basal flow by 100 percent).
Secondary aims:
- Characterisation of hypoglycaemia during and after physical activity based on CGMS data: symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of hypoglycaemia in relation to the start of physical activity, degree and severity of hypoglycaemia.
- Evaluation of overall variations in blood glucose in the event of physical activity using CGMS data (area under the curve).
- Evaluation of glucose restoration methods used in the event of hypoglycaemia.
- Analysis of subgroups of patients with and without hypoglycaemia.
详细描述
Inclusion criteria:
- Patients aged over 18 years, presenting type 1 diabetes for at least 1 year
- Patients on basal-prandial regimen treated with functional insulin therapy
- Patients with a subcutaneous insulin pump for at least 3 months
- Patients with HbA1c less than 9 percent less than 3 months before
- Patients with stable basal flow for at least 1 week
- Patients able to pedal
- Patients covered by social security
- Patients consenting to take part in the study and having signed a written informed consent form.
Non-inclusion criteria:
- Patients with a history of severe hypoglycaemia in the 6 months prior to entry into the study
- Patients unable to detect their hypoglycaemia
- Patients with perforating foot ulcer or a known history of heart disease or obliterative arteriopathy of the lower limbs, or a history of cerebrovascular accident, or ongoing proliferative retinopathy or renal failure.
- Patients with poorly controlled hypertension
- Women either pregnant or likely to become pregnant
- Patients deprived of liberty by judicial or administrative decision, patients placed under legal guardianship.
Primary criterion:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Patients aged over 18 years, presenting type 1 diabetes for at least 1 year
- •Patients on basal-prandial regimen treated with functional insulin therapy
- •Patients with a subcutaneous insulin pump for at least 3 months
- •Patients with HbA1c < 9% less than 3 months before
- •Patients with stable basal flow for at least 1 week
- •Patients able to pedal
- •Patients covered by social security
- •Patients consenting to take part in the study and having signed a written informed consent form.
排除标准
- •Patients with a history of severe hypoglycaemia in the 6 months prior to entry into the study
- •Patients unable to detect their hypoglycaemia
- •Patients with perforating foot ulcer or a known history of heart disease or obliterative arteriopathy of the lower limbs, or a history of cerebrovascular accident, or ongoing proliferative retinopathy or renal failure.
- •Patients with poorly controlled hypertension
- •Women either pregnant or likely to become pregnant
- •Patients deprived of liberty by judicial or administrative decision, patients placed under legal guardianship.
结局指标
主要结局
Number of episodes of symptomatic or non-symptomatic hypoglycaemia
时间窗: 24 hours
Number of episodes of symptomatic or non-symptomatic hypoglycaemia detected by CGMS throughout the duration of physical activity and subsequent hours until the next morning (threshold: 3 mmol/l or 0.54 g/l).
次要结局
- Duration of hypoglycaemia(24 hours)