A Randomized Trial of the Effect of Continuous Glucose Monitoring (CGM) in Individuals With Type 1 Diabetes Treated With Multiple Daily Insulin Injections (MDI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 30
- 主要终点
- Difference in HbA1c between week 26 and week 69
研究概览
简要总结
Breif summary
A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels has been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option for notifying the patient on trends in glucose levels and warning when these are estimated to be too high and too low.
In some countries today, Sweden among others, CGM is reimbursed in combination with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adult type 1 diabetic patients. This is based on existing clinical trials showing a beneficial effect on HbA1c by combining CGM with CSII. However, the majority of adult type 1 diabetic patients are treated with multiple daily insulin injections (MDI). Clinical trial data are sparse on the effect of CGM in adult type 1 diabetic patients treated with MDI, and there are no clinical trial data including only patients on MDI.
The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction among adult type 1 diabetic patients on CGM treated with MDI. The design is a 69-week, cross-over clinical trial, including 26 weeks treatment with CGM, 26 weeks treatment with conventional SMBG and a wash-out period of 17 weeks. In total 120 patients will be included at 8 sites in Sweden. The study will have 80% power to detect a 3 mmol/mol (0.3 percentage unit) change in HbA1c resulting from CGM.
详细描述
Background
A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control (1). Today, intensive glycaemic treatment is generally achieved through multiple daily insulin injections (MDI) or an insulin pump, also termed continuous subcutaneous insulin infusion (CSII, [2]). Regular capillary self-measured blood glucose values have been most crucial in obtaining good glycaemic control and guiding the patient on insulin doses (3, 4, 5).
During recent years continuous glucose monitoring (CGM) has become a treatment option for guiding the patient on insulin dosage and other activities (6). CGM has the advantage of informing the patient on estimated glucose values continuously, not the least important of which is to illustrate trends on increases or decreases in glucose levels.
Data from several clinical trials on CGM has shown divergent results on its glycaemic control effects (7). In some clinical trials, only patients on CSII have been included or have initiated CGM and CSII simultaneously as an intervention. In other trials both patients with MDI and CSII have been included, and post hoc analyses have also resulted in divergent findings whether the effect on glycaemic control potentially differs when combining CGM with MDI or CSII (8, 9, 10). Although the absolute majority of adult type 1 diabetic patients are treated with MDI, clinical trials initiating CGM in a pure MDI-treated group are absent.
The current trial is a cross-over design and 69 weeks in duration, where patients will be randomized patients to CGM-treatment for 26 weeks, conventional therapy for 26 weeks and a wash-out period for 17 weeks. The primary endpoint is the effect on HbA1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Type 1 diabetes
- •Adults 18 years or older
- •Written Informed Consent
- •HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard)
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 judged by the physician to be 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 DexComG
- •However, other pain killers can be used throughout the study duration.
- •Current CGM use. (within the past 4 months
- •History of allergic reaction to any of the CGMS materials or adhesives in contact with the skin.
- •History of allergic reaction to chlorhexidine or alcohol antiseptic solution.
- •Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- •Patient is uncomfortable by using the sensor during the blinded run-in period and believes it is unlikely that he/she will use the sensor more than 80% of the time during the trial.
- •The patient has on average performed 12 or less calibrations per week during the run-in period.
- •Insulin pump therapy=Continuous subcutaneous insulin infusion (CSII)
- •Diabetes duration < 1 year
- •Participation in another study.
- •Fasting C-peptide level of 0.3 nmol/l or higher
- •eGFR < 30 ml/min (estimated from creatinine, age and sex at the inclusion visit by the MDRD-formula)
- •Planned house move during the next 1.5 years, making it difficult to come to study visits
- •Other investigator-determined criteria making patients unsuitable for participation.
结局指标
主要结局
Difference in HbA1c between week 26 and week 69
时间窗: Week 26, week 69
次要结局
- Difference in the proportion of time with high glucose levels measured by CGM during two weeks between week 23-26 and week 66-69 measured by CGM (above 10.0 mmol/l and above 13.9 mmol/l respectively)(Week 23-26, week 66-69)
- Difference in the proportion of patients reducing their HbA1c by 5 mmol/mol (0.5% in DCCT) or more(Week 26, week 69)
- Difference in the mean number of severe hypoglycaemic events between weeks 1-26 and weeks 43-69 defined as unconsciousness due to hypoglycaemia or need of assistance from another person to resolve the hypoglycaemia(Week 1-26, week 43-69)
- Difference in WHO 5 scores between weeks 26 and 69(Week 26, week 69)
- Difference in SWE-HFS scores between weeks 26 and 69(Week 26, week 69)
- Difference in the proportion of time with euglycaemic levels measured by CGM during two weeks between weeks 23-26 and weeks 66-69 (5.5-10.0 mmol/l and 3.9-10.0 mmol/l respectively)(Week 23-26, week 66-69)
- Difference in SWE-PAID-20 scores between weeks 26 and 69(Week 26, week 69)
- Difference in the proportion of time with low glucose levels measured by CGM during two weeks between week 23-26 and week 66-69 measured by CGM (below 3.0 mmol/l and below 4.0 mmol/l respectively)(Week 23-26, week 66-69)
- Difference in mean glucose level measured by CGM between week 23-26 and 66-69(Week 23-26, week 66-69)
- Difference in DTSQs scores between weeks 26 and 69(Week 26, week 69)
- Difference in mean amplitude glucose excursion (MAGE) measured by CGM between week 23-26 and week 66-69(Week 23-26, week 66-69)
- Difference in standard deviation of glucose levels measured by CGM between week 23-26 and week 66-69(Week 23-26 and week 66-69)
- DTSQc score at week 69(Week 69)
- Difference in the proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more(Week 26, week 69)