Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Percentage of total time spent by patients in safe range (70-180mg/dL)
研究概览
简要总结
The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.
详细描述
During this study, we would like to assess the efficacy in keeping blood glucose in a safe range (70-180 mg/dL) of the second generation of a Glucose Predictive and Therapy Advisory system in diabetic patients treated by basal-bolus insulin regimens using pumps or multiple daily injections. We want to compare the time spent in safe range while using the predictor and advisor outputs and when the patient is not using them. This is a randomized controlled crossover trial. Patient will come for two admissions of 3 days, one with the DIAdvisor system fully activated, and one with the prediction and advice features disabled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be aged between 18 (inclusive) and 70 years old
- •Patients diagnosed with type 1 or type 2 diabetes according to WHO criteria for at least one year prior to study entry
- •Patient treated by a basal-bolus insulin therapy using an external pump or multiple-daily injections. The insulin regimen has to be stable for the previous six months. NPH insulin use will not be acceptable.
- •Patient should have stable diabetes with a HbA1c between ≥ 7.5 % and < 10.5 % with no keto-acidosis for the previous 6 months.
- •Patient must have a Body Mass Index (BMI) lower than 35 Kg/m²
- •Patient must be willing to undergo all study procedures
- •Patient must be affiliated or beneficiary of a social medical insurance
- •Patient has signed informed consent form prior to study entry
排除标准
- •Patient is pregnant, or breast feeding during the period of the study
- •Patient has impaired renal function with a creatinine blood concentration over 150 μmol/L
- •Patient has a liver disease (ALAT, ASAT > 2 x upper limit of normal range)
- •Patient is treated by sulfamides, GLP-1 analogues, DPP-IV inhibitors or glitazones
- •Alcohol or drug addiction, as identified by investigator during screening visit
- •Allergy to sensors or one of their components
- •Manifest psychological disorders
- •Patient health status is not compatible with physical exercise
- •Patient is actively enrolled in another clinical trial or was part of study within 30 days
- •Persons deprived of freedom, adults protected by law or vulnerable persons
研究组 & 干预措施
algorithm DIAdvisor activated
Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.
干预措施: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) (Device)
algorithm of DIAdvisor disactivated
Glucosepredictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.
干预措施: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) (Device)
结局指标
主要结局
Percentage of total time spent by patients in safe range (70-180mg/dL)
时间窗: during 3 days with DIAdvisor 2
The primary endpoint is the percentage of total time spent by patients in safe range (70-180mg/dL). A clinically significant benefit will be reached if an increase of at least 10% of total time in range is obtained while using DIAdvisor-2.
次要结局
- Score of patient survey regarding the acceptability of DIAdvisor-2 system(during 3 days with DIAdvisor 2)
- Mean of YSI blood glucose during total period, night time and meal periods(during the two 3 days-hospitalizations)
- Percentage of total time spent in hypoglycemia (< 70 mg/dL)(during 3 days with DIAdvisor 2)
- Percentage of total of time spent in hyperglycemia (>180 mg/dL)(during 3 days with DIAdvisor 2)
- Percentage paired glucose values(during 3 days with DIAdvisor 2)
- Coherence between system advices and physician recommendations > 0.80(during 3 days with DIAdvisor 2)