Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Comparison of HbA1c means
研究概览
简要总结
TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)
详细描述
All patients will attend a functional insulin therapy training course and be randomized into 2 groups. One group will receive a PDA-phone and one month of phone consultations with a nurse and a physician. The other group will only have the usual paper support. This study compares the evolution of HbA1c in the 2 groups over a period of 3 months. It also assesses time spent by nurses and physicians, changes in quality of life, hypoglycaemia frequency and weight changes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for ≥ 6 months or more
- •Age > 18 year old
- •The patient has attended a functional insulin therapy class or workshop
- •Insulin basal-bolus therapy for at least 6 months. At inclusion, patients should be treated either with a long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
- •Ability to understand how the PDA-phone works and ability to use it
- •Social Security membership or benefit from Social Security
- •Patients equipped with a memory blood glucose monitor
- •Informed consent, with a signed and approved form
排除标准
- •Underage patient, major patient under guardianship or protected by the Law
- •Patient with any unstable associated evolutive pathology that could cause a diabetes imbalance within the coming year
- •Change in diabetes treatment within the 3 months before inclusion or planned during the study
- •Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
- •Patient attending another education program within the 3 months before inclusion or planning to attend one during the study
- •Patient with toxicomania, alcoholism or psychological troubles that could impact the study
- •Type-2-diabetic patient
- •Patient who doesn't need strict metabolic objectives
- •Pregnant or possibly pregnant woman
- •Person with no freedom (prisoner)
结局指标
主要结局
Comparison of HbA1c means
时间窗: M0 (start) and M3 (3 months)
次要结局
- Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session(M0 (start) and M3 (3 months))
- DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire(M0 (start) and M3 (3 months))
- Time spent by physicians and nurses in the different groups(M0 (start) and M3 (3 months))
- Weight changes during the 3-month period(M0 (start) and M3 (3 months))
- Number of hypoglycemias (moderate and severe) during the 3-month period(M0 (start) and M3 (3 months))