Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (Hba1c)
研究概览
简要总结
The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits.
详细描述
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Objectives
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To evaluate the effect of telecare on glycemic control for patients with type 1 diabetes (T1DM).
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To assess the cost of telecare to Maccabi, the patient and the economy.
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To assess patients' quality of life and satisfaction with telecare intervention.
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To assess the effect of telecare intervention on insulin adjustment to consumed carbohydrates.
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Working hypothesis Telecare can be used for efficient management of T1DM in adults using insulin pump, in lieu of frequent clinic visits.
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Methodology A randomized controlled prospective trial for one year. Intervention group: Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.
Control group: 3-month routine clinic visits 4. Significance of the proposed research (its uniqueness and innovation) Telecare potentially offers a method for efficient continuous care management of patients with T1DM using insulin pump in lieu of clinic visits. It enables real time responses of clinical personnel and increases patient involvement. This trial will be the first telecare intervention lasting for one year to determine if treatment is as efficient as face to face visits, thus enabling cost reduction and time saving without affecting the quality of care. .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T1D lasted >1 year, age 22 and up, using insulin pump
- •Patients possessing a mobile phone and internet access
排除标准
- •Patients with Severe target organ damage
- •Patients with Mental retardation
- •Patients with Eating disorders
- •Pregnant patients or patients planning pregnancy
结局指标
主要结局
Change in Glycosylated Hemoglobin (Hba1c)
时间窗: From date of randomization every 3 months, up to one year
次要结局
- Time spent on data analysis and telephone calls by team(1 year)
- Number of severe hypoglycemic and diabetic ketoacidosis (DKA) events and hospitalizations(1 year)
- Patients' quality of life(1 year)
- Patients' satisfaction(1 year)
研究者
Bruria Sher
Dietitian
Assuta Hospital Systems