Evaluation of Telemedicine on Metabolic Control in the Care of Diabetes Mellitus Type 1 Patients in Multiple Doses of Insulin Treatment in Andalusian Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1 diabetes mellitus (DM1) and regular metabolic control (HbA1c <8%) in multi-dose insulin treatment (MDI) measured HbA1c vs. conventional medical care.
详细描述
The substitution of face-to-face visits for telematics visits has a similar effect on glycemic control (measured by HbA1c) in patients with DM1 treated with multiple daily doses of insulin (MDI) and regular metabolic control (HbA1c <8 %). It even saves costs and consumption of health resources, and improves the quality of life and satisfaction of subjects with DM1
To evaluate the effect of a 6-month Diabetic platform on telemedicine in patients with DM1 and regular metabolic control (HbA1c <8%) on MDI treatment in the following parameters:
A) Glycemic control: Mean glycemia, number of mild hypoglycemia / week, number of severe hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , Number of hospital admissions due to glycemic decompensation / 6 months.
B) Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).
C) Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life Questionnaire (DQoL). E) Stress: DDS questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DM1 over 2 years of evolution.
- •Age ≥18 and <65 years.
- •HbA1c prior to inclusion of the study <8% (the measure being valid in the month prior to inclusion in the study)
- •Intensive insulin therapy with basal-bolus MDI.
- •Patients living in Andalusian
- •Patients candidates for telemonitoring.
- •Patients who have received written informed consent.
排除标准
- •Treatment with ISCI.
- •Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- •Pregnancy or pregnancy planning.
- •Diabetes mellitus type
- •Severe psychological disturbances.
- •Absence of collaboration (informed consent).
- •Patients who are participating in other clinical studies.
研究组 & 干预措施
Telemedicine group
Telematics visit in front of the conventional visit face to face
干预措施: Telemedicine group (Other)
Conventional group
Group with conventional medical visit
干预措施: Conventional group (Other)
结局指标
主要结局
HbA1c
时间窗: 6 months
Glycosylated hemoglobin
次要结局
- Quality of life(6 months)
- Mean blood glucose(6 months)
- Total daily dose of insulin(6 months)
- Number of severe hypoglycemia(6 months)
- Number of episodes of ketosis number of episodes of ketoacidosis(6 months)
- Cost of hypoglycaemic treatment (insulin)(6 months)
- Standard deviation(6 months)
- Total daily dose of insulin by weight(6 months)
- Number of mild hypoglycaemia(6 months)
- Number of hyperglycemia greater than 250 mg / dl / week(6 months)
- Number of hospital admissions due to glycemic decompensations(6 months)
- Time invested in the care of each patient(6 months)
- Number of telephone calls(6 months)
- Fear of hypoglycemia: FH-15 scale(6 months)
- Stress: DDS questionnaire(6 months)
- Number of face-to-face visits(6 months)
- Analytics performed in the center(6 months)
- Analytic done in domestic scope with glucometer(6 months)
- Costs and consumption of health resources(6 months)
- Costs associated with the time spent going to the patient's hospital and family members(6 months)
- Costs associated with days lost due to complications.(6 months)