Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Comparison of metabolic control (HbA1C) between diabetic patients followed by teleconsultation and patients with a conventional follow-up during Covid-19 infection.
研究概览
简要总结
Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Among the hospitalized patients reported in the initial Chinese studies, 48% had co-morbidity, particularly diabetes or cardiovascular disease. Covid-19 infection does not appear to be more common in diabetic patients, but infected diabetics have more severe forms.
The prevalence of diabetes is high in Alsace affecting 6.5% of the population against 4.6% in France. Du to health containment measures, asymptomatic diabetic patients can no longer come to the clinic in Hospital for their consultation. However, in the current epidemiological context, maintaining optimal glycemic control is fundamental since some of diabetic patients will have Covid-19 infections. Furthermore, the sedentary lifestyle and snacking linked to the confinement period will contribute to a glycemic imbalance in some patients. Telemedicine, and in particular teleconsultation, which until now has been very uncommon in the management of diabetic patients, represents a very interesting alternative for monitoring these patients and maintaining satisfactory metabolic control during the current period of confinement and Covid-19 epidemic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult diabetic patient (type 1,2, MODY, secondary, post transplantation) followed by diabetology consultation at the hospital or by a liberal diabetologist
- •Subject affiliated to a social health insurance
- •Subject able to understand the objectives of the research
- •Subject who expressed his non opposition to the research
排除标准
- •Pregnant woman
- •Patients with acute complications (foot ulcer, post stroke, post IDM)
- •Cancer or life expectancy of less than 6 months
- •Inability to provide informed information to the subject (subject in an emergency, difficulty of understanding for the subject, etc.)
- •Subject under judicial protection
- •Subject under guardianship or curatorship
结局指标
主要结局
Comparison of metabolic control (HbA1C) between diabetic patients followed by teleconsultation and patients with a conventional follow-up during Covid-19 infection.
时间窗: HbA1C measured at 3 months post-telemedicine consultation group / post-cancellation of the face-to-face consultation group (variation versus basal)
In the Covid 19 epidemic context, the face-to-face consultation of diabetic patients with the hospital's physician or their diabetologist is / will be replaced by a teleconsultation ( phone or computer consultation) followed at 6 months of a face-to-face consultation. Patients will be monitored in accordance with routine practice. The Teleconsultation (TC) group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist has been replaced by a teleconsultation due to the availability of diabetologists whose activity is focused on the management of Covid-19 negative patients. The Face-to-Face group will be composed of patients for whom the consultation initially scheduled in the presence of the diabetologist was postponed by 6 months due to the activity of some diabetologists entirely redirected towards the management of Covid-19 positive patients.
次要结局
- Number of patients infected with Covid-19 (positive smear by RT-PCR for SARS-CoV-2 virus).(Number of patients infected with Covid-19 during the study (6 months).)
- Number of conventional hospitalizations, in intensive care and deaths.(Number of conventional hospitalizations, in intensive care and deaths during the study (6 months).)
- HbA1C measured at 6 months post-telemedicine consultation for the TC group / post-cancellation of the face-to-face consultation for the P group.(HbA1C will be measured at visit V2 (6 months after inclusion visit)=through study completion, an average of 6 months)
- Total number of patients inaccessible to teleconsultation and number of patients inaccessible by type of associated reason.(Total number of patients inaccessible to teleconsultation will be collected through study completion, an average of 6 months.)
- Number of complications: severe hypoglycemia, ketoacidosis, myocardial infarction, stroke, foot ulcer.(Number of complications through study completion, an average of 6 months.)
- Results of patient satisfaction questionnaire.(Patients will respond to the questionnaires either at the end of study (6 months after inclusion) or in the month following the teleconsultation.)
- Results of doctor satisfaction questionnaire.(Physician will respond to the questionnaires at study completion, 6 months after the inclusion visit.)