Kids Diabetes Telemedicine Study (KITES)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- metabolic control (HbA1c concentrations) at Month 9
研究概览
简要总结
Randomised prospective single-center clinical trial evaluating the outcomes of children with type 1 diabetes followed up by remote telemedicine check-ups without their personal present at the outpatient clinic.
详细描述
At the first study visit (visit Month 0), after obtaining the written informed consent from the parents, 50 children with type 1 diabetes will be randomised to two groups of equal size.
The first group will have regular visits with their diabetologist to our outpatient clinic every 3 months (visits Month 3 and Month 6), the second group will have a remote control by email only instead of regular visits (visits Month 3 and Month 6). The CGM data and inzulin dose will be evaluated through cloud systems (Diasend, Carelink) at every control by diabetologist. The patients would be instructed about the reccomendation during the "live" control or by email according the group. The final meeting (visit Month 9) will take place at our outpatient clinic for both of the study groups. The CGM data, HbA1c, and the questionaire evaluating the quality of the controls will be evaluated.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes
- •Age 1-18 years
- •Type 1 diabetes duration at least 12 months
- •Using continuous glucose monitoring for at least previous 6 months
- •Willingness to use continuous glucose monitoring for the whole study
- •Signed informed consent by the legal representatives
排除标准
- •Change of the type 1 treatment modalitry (from insulin pens to insulin pump or vice versa, start the treatment with hybrid closed loop, start of the treatment with the drug affecting the glucose metabolism) in 3 months prior to the study or planning to change the treatment modality during the study
- •Concomitant psychiatric diagnosis diagnosed by the psychiatrist
- •Hospitalisation for severe hypoglycaemia and/or diabetic ketoacidosis in 1 year prior to the study initiation
- •Glycated hemoglobin concentration >90 mmol/mol in 1 year prior to the study or substantially bad co-operation of the patient/parent
结局指标
主要结局
metabolic control (HbA1c concentrations) at Month 9
时间窗: Month 9 visit
The noninferiority of HbA1C concentration between the groups (the difference of HbA1c between the groups will be less than 5 mmol/mol,
次要结局
- Control of glycemia levels by CGM data evaluation.(Month 3, Month 6, and Month 9)
- Duration of the dia visit(Month 3and Month 6)
- Patient´s satisfaction of regular and telemedicine (email) visits.(Month 9)
研究者
Lenka Petruzelkova
Principle investigator - Lenka Petruzelkova, MD, PhD.
University Hospital, Motol