Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
研究概览
简要总结
Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Therefore, self-management of patient with type 1 diabetes must be systematically assessed in order to evaluate the effectiveness of education programs .The main objective of this prospective controlled randomized monocentric study is to assess the impact of functional insulin therapy on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes Self-care scale (CIDS) test.
详细描述
170 patients with type 1 diabetes, volunteering for education to functional insulin therapy, will be recruited by the Department od Endocrinology, Diabetes, Nutrition of Montpellier University Hospital.
After inclusion, the patients will be randomized in 2 groups: group 1 will be immediately trained to functional insulin therapy and group 2 will be trained at the end of the study. The patients will be met as outpatients 3 months after inclusion. The primary endpoint will be the global score for CIDS questionnaire.
Secondary endpoints will include: HbA1c level at month 3, frequency of hypoglycemia from inclusion to month 3, scores for each of the 20 items of CIDS questionnaire.
An ancillary study will assess: the acceptability of the new EAD questionnaire which specifically evaluates the self-management of diabetes, the concordance validity of EAD and CDIS questionnaires, the reproducibility test-retest, the internal consistency and the sensitivity to change of EAD questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Type 1 diabetes from at least 1 year
- •Age from 18 to 70 (70 not included)
- •Basal-bolus multiple-dily insulin injections or insulin pump (CSII)
- •Informed consent
- •Affiliated or benefit from an insurance regimen
排除标准
- •Type 2 diabetes
- •Unable to make mathematic calculation
- •Pregnancy, breast-feeding or absence of effective contraception
- •Psychiatric and/or cognitive status uncompatible with study
- •Eating disorders
- •Law protected person, vulnerable person
结局指标
主要结局
To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
时间窗: three months (from inclusion until end of study)
CIDS questionnaire
次要结局
- To assess the effect of education to functional insulin therapy on HbA1c level(three months (from inclusion until end of study))
- To assess the effect of education to functional insulin therapy on hypoglycemia frequency(three months (from inclusion until end of study))
- To assess the validity, the concordance and the sensitivity to change of EAD questionnaire (specific for self-management of diabetes) in comparison with CIDS test(three months (from inclusion until end of study))
- To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire(three months (from inclusion until end of study))