CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- DTSQc
研究概览
简要总结
This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs.
A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.
详细描述
This is a multi center prospective cohort study in Europe with pre- and post-measurements in type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be retrieved from their medical records and from uploaded data of their medical devices used for their type 1 diabetes treatment.
The study will consist of two periods. A 3 months' retrospective period in which data will be retrieved from patients' dossier followed by a 12 months' prospective period after introduction of CloudCare as part of patients' standard care by the treating physician.
The 3 months' retrospective period is the control period for the prospective period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents/caregivers and, depending on local laws and regulations, also the patient are willing to sign the study informed consent form prior to any data collection for this study
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes and using insulin with or without metformin for at least 6 months.
- •Age between 1 and 15 years old.
- •Use of multiple daily injections of insulin (MDI, with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion (CSII) with Flash or Continuous Glucose Monitoring (FGM/CGM), but without CloudCare for at least three months.
- •Receiving CloudCare as part of their standard care for at least 6 months.
排除标准
- •Patients with type 1 diabetes on glucose lowering treatments other than insulin with or without metformin.
- •Any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.
结局指标
主要结局
DTSQc
时间窗: 6 months
Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents
次要结局
- Change in mean % HbA1c(-3 months to 3, 6 and 12 months)
- Change in mean TIR(-3 months to 3, 6 and 12 months)
- Change in mean PAID-teens and PAID-parent(0, 3, 6 and 12 months)
- Change in mean TAR(-3 months to 3, 6 and 12 months)
- Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire(0, 3, 6 and 12 months)
- DTSQs(0, 6, 12 months)
- Change in mean TBR(-3 months to 3, 6 and 12 months)
- Change in mean QoL score and mean QoL diabetes related score(0, 3, 6 and 12 months)
- Treatment costs(0, 3, 6 and 12 months)