NCT01955031已完成不适用
Effectiveness and Cost-effectiveness Analysis of a Telemonitoring Program on Lifestyle for People With Type 2 Diabetes at Home. Study Based on a Health Network in Diabetology.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 2
- 主要终点
- To assess effectiveness of our telemonitoring program in Diabetes care, HbA1C assays will be compared between the two groups.The change of HbA1c between day 0, month 1,month 3, month 6, month 9 and month 12
研究概览
简要总结
Severity of diabetes is related to the development of disabling and costly complications (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus. Despite these recommendations, patients often have difficulties to implement dietary recommendations every day. The objective of EDUC@DOM is to help people with diabetes to improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of the patients. It is expected that our program leads to a better monitoring of health status, a greater adherence to medical and non-medical prescriptions, an empowerment of the patient, and as a consequence, a more efficient health care consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patient with type 2 diabetes
- •Older than 18 years
- •With an insulin treatment or not
- •Having a glycemic impairment characterized by 6.5% <HbA1c ≤10
- •Having an active internet connection at home.
- •Accepting the terms of training, loan and use of the device
- •Benefiting from social protection system
- •Having given his/her free and informed consent and signed the consent
排除标准
- •Serious illness recently (<3 months) or decompensated may influence glycemic control of the patient permanently according to the judgment of the physician in charge of monitoring
- •Retinal state that does not allow optimization in equilibrium of glycaemia
- •Known severe renal impairment defined by creatinine clearance <30ml/min
- •Known hemoglobinopathy
- •Visual or intellectual resulting inability to use the remote monitoring tool according to the judgment of the physician in charge of monitoring
- •Inability to understand all or part of the software information according to the judgment of the physician in charge of monitoring
- •Subject to disabled
- •Person with severe behavioral disorders (anorexia, bulimia, ...) according to the judgment of the physician in charge of monitoring
- •Person who had, or in preparation for bariatric surgery (software nutrition education are not suitable for this type of care.)
- •Person with a medical device implanted electronic pacemakers and defibrillators with cardiac (possibility of interference with the impedance)
- •Another person involved in research including a period of ongoing exclusion to inclusion,
- •A person under legal protection
- •Subject living in institutions
- •Desire for pregnancy, pregnancy or breastfeeding
结局指标
主要结局
To assess effectiveness of our telemonitoring program in Diabetes care, HbA1C assays will be compared between the two groups.The change of HbA1c between day 0, month 1,month 3, month 6, month 9 and month 12
时间窗: HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12
次要结局
- Food inquiries will be given to patients to assess the improvement of eating habits(At day 0 and month 24)
- Questionnaires will be given to patients to assess the physical activity practice(At day 0 and month 24)
- Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),(At day 0 and month 24)
- The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia(At day 0, month 12 and month 24)
- For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software(Everytime patients use the software from Day0 to month 24)
- For the telemonitoring arm, assessment of physical activity declared through Acti-Kiosk software and measures collected with the pedometer (number of steps, number of stairs climbed up)(Every time patients use the software and the pedometer from day 0 to month 24)
- For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections(At month 24)
- For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire(At month 24)
- Assessment efficacy of our program by the measure of HbA1C will(At month 15, month 18, month 21 and month 24)
- For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections leading to a medical decision (phone call or medical appointment) and a questionnaire(At month 24)
- Questionnaires will be given to patients to assess the improvement of nutritional knowledge(At day 0 and month 24)
- A blood sample will be collected to assess lipid status(At day 0 and month 24)
- Two questionnaires will be given to patients to assess quality of life of patients(At day 0 and month 24)
- A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects(At month 24)
- For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software(Everytime patients use the software from Day 0 to month 24)
- For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance(Everytime patients use the balance from day 0 to month 24)
- For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device(Everytime patients use the blood glucose device from day 0 to month 24)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular RiskCardiovascular AbnormalitiesChronic Kidney DiseasesDiabetesNCT03958760West China Hospital200,000
终止
不适用
Time To Complications Occurs in DiabetesNephropathyVascular DiseaseIschemic Heart DiseaseDiabetic NeuropathyRetinopathyNCT00969956Karolinska Institutet17
Unknown
不适用
A Study to Investigate the Benefits of the Early Detection and Intensive Treatment of Type 2 DiabetesType 2 Diabetes MellitusNCT00318032University Hospitals, Leicester8,579
招募中
2 期
Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT06010992Tanta University70
已完成
不适用
Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable TherapyDiabetes Mellitus Type 2NCT02843399AstraZeneca15,498