Long-term Effects of Continuous Glucose Monitoring in Patients With Type 1 Diabetes Treated With Multiple Daily Insulin Injections - Extension of CGMMDI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- HbA1c in venous sample
研究概览
简要总结
A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option to inform the patient when glucose levels may be too high or low.
In some countries, including Sweden, CGM is reimbursed only when combined with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM over 6 months, followed by conventional therapy over six months, with a four-month wash-out period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.
From a research or regulatory standpoint, long-term data on treatment effects are expected to a greater extent today than in previous years, due to various reasons, e.g., to evaluate any sustained beneficial effects over time, or long-term patient safety. Accordingly, follow-up of treatment in an extension phase after randomized diabetes trials have become more common over time, especially where many novel glucose-lowering treatments are concerned. Therefore, the aim of the current study is to evaluate long-term effects of CGM in patients with type 1 diabetes treated with MDI. Patients who consent in an extension phase over 1 year of the CGMMDI trial will receive CGM, and evaluations will be performed on sustained glycaemic control effects, hypoglycaemia, glycaemic variability, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Completion of the CGMMDI trial.
- •Written informed consent.
排除标准
- •Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
- •Severe cognitive dysfunction or other disease, which is adjudicated by a physician as not suitable for inclusion.
- •Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the Dexcom. However, other pain killers can be used throughout the study duration.
- •History of allergic reaction to any of the CGM materials or adhesives in contact with the skin, or to chlorhexidine or alcoholic anti-septic solution.
- •Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- •Other investigator-determined criteria making patients unsuitable for participation.
研究组 & 干预措施
Long-term CGM
Continuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial
干预措施: Dexcom G4 or later generation (Device)
结局指标
主要结局
HbA1c in venous sample
时间窗: 52 weeks or 78 weeks
For all variables, measurement at the end of this extension of a cross-over study will be compared to the measurement before long-term CGM was initiated.
次要结局
- Well being: WHO 5 scores(52 weeks/78 weeks)
- Proportion of time with low glucose levels measured by CGM during two weeks.(52 weeks/78 weeks)
- Proportion of time with euglycaemic levels measured by CGM during two weeks.(52 weeks/78 weeks)
- Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more.(52 weeks/78 weeks)
- Problem areas: SWE-PAID-20 scores(52 weeks/78 weeks)
- Mean glucose level measured by CGM during two weeks.(52 weeks/78 weeks)
- Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.(52 weeks/78 weeks)
- Standard deviation of glucose levels measured by CGM during two weeks.(52 weeks/78 weeks)
- Hypoglycemia fear: SWE-HFS scores(52 weeks/78 weeks)
- Physical activity: IPAQ score(52 weeks/78 weeks)
- Treatment experience of CGM score(52 weeks/78 weeks)
- Proportion of time with high glucose levels measured by CGM during two weeks.(52 weeks/78 weeks)
- Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more(52 weeks/78 weeks)
- Treatment satisfaction: DTSQs scores(52 weeks/78 weeks)
- Number of self-reported severe hypoglycaemic events per year(52 weeks/78 weeks)