A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed.
A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.
The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
- •Clinical diagnosis of Type 1 diabetes
- •Adult patients over 18 years of age
- •HbA1c ≥ 58 mmol/mol
- •Currently using CGM or FGM
- •To have a possibility to download and share FGM/CGM data
排除标准
- •Type 2 diabetes
- •Diabetes duration <1 year
- •Long-term Systemic glucocorticoid treatment during the last 3 months
- •Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
- •Current or planned pregnancy or breastfeeding during the next 12 months
- •Planned move during the next 12 months making it not possible to participate in study activities
- •Other reason determined by the investigator not being appropriate for participation
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to 18 weeks
Change in HbA1c from baseline to week 18
次要结局
- Mean glucose levels(from baseline to 18 weeks)
- HbA1c at week 52(From baseline to 52 weeks)
- HbA1c at week 32(From baseline to 18 weeks)
- Time in Range(from baseline to 18 weeks)
- Time above range(from baseline to 18 weeks)