Effectiveness of a Multidisciplinary Treatment and Structured Education for Type 1 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Changes in Glycemic Control Measured by A1c
研究概览
简要总结
This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.
详细描述
Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The standard educational and treatment program consists of outpatient management and education in the office and consultation referral to nutrition and psychology with a duration of 4 months.
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes
- •Diabetes duration >1 year
- •BMI 18.5-40kg/m2
- •A1c 6.5-13%
排除标准
- •Pregnancy
- •Dementia or severe cognitive impairment
- •Uncontrolled psychiatric disorder
- •Absence of >20% of the educational sessions
研究组 & 干预措施
Educational programme 12
The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.
干预措施: Educational programme 12 (Behavioral)
Standard
The standard educational program consists of outpatient management with diabetic education slides and material for the patient, with a duration of 4 months. Standard treatment consists of endocrinology consultation with nutrition and psychology referral if required
干预措施: Standard education and treatment (Behavioral)
结局指标
主要结局
Changes in Glycemic Control Measured by A1c
时间窗: Baseline and 6 months
Difference between baseline A1c and A1c at 6 month follow up
次要结局
- Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol(Baseline and 6 months)
- Changes in insulin resistance control Measured by eGDR(Baseline and 6 months)
- Changes Anthropometry Measured by BMI and WC(Baseline and 6 months)
- Changes in Glycemic Control Measured by severe hypoglycemia(Baseline and 6 months)
- Changes in Mental health Measured by DDS, GAD7 and PHQ9(Baseline and 6 months)
研究者
David Sanchez Garcia
Principal investigator
Instituto Mexicano del Seguro Social