A Randomized Trial of the Effect of Continuous Glucose Monitoring (CGM) in Individuals With Newly Diagnosed Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- HbA1c
研究概览
简要总结
The aim of the current study is to evaluate effectiveness, sustainability and satisfaction of CGM in adult persons with newly diagnosed type 2 diabetes. The study is a randomized clinical trial randomizing patients to CGM or SMBG over 26 weeks with a follow-up period up to 70 weeks. An extension period will exist between 26 and 70 weeks. Between 26-52 weeks both groups will use only capillary testing for glucose monitoring and during 53-70 weeks the group initially randomized to capillary testing will use CGM. During the extension period similar variables will be evaluated as during the main phase of the trial including HbA1c, CGM-metrics, glucose-lowering medications, physical activity, treatment satisfaction and well-being.
详细描述
A keystone in preventing complications in persons with type 2 diabetes is good glycaemic control as soon as possible after onset of diabetes. The basic treatment is optimizing lifestyle factors with increased physical activity, weight control and a healthy diet. In addition to glucose control, it is important that blood pressure and blood lipids are well regulated. Self-monitoring of blood glucose (SMBG) by repeated capillary glucose measurements has been a standard for regulating plasma glucose levels and to give information about the influence of lifestyle. In recent years continuous glucose monitoring (CGM) has become an option for guiding the patient by immediate feedback on the influence of lifestyle, such as physical activity and diet.
Previous studies indicate that CGM helps and encourages people with type 2 diabetes to improve their lifestyle and that it is highly appreciated.. However, it is relatively expensive and the effect of CGM on glycaemic control may fade over time.
No previous study has examined the effect of CGM on lifestyle in individuals with newly diagnosed type 2 diabetes. Individuals with newly diagnosed diabetes are more prone to change their lifestyle while quick improvement of glucose measurements also is of uttermost importance.
The aim of the current study is to evaluate effectiveness, sustainability and satisfaction of CGM in adult persons with newly diagnosed type 2 diabetes. The study is a randomized clinical trial randomizing patients to CGM or SMBG over 26 weeks with a follow-up period up to 70 weeks. The primary endpoint is effect on HbA1c over 26 weeks. Other essential endpoints over 26 weeks of treatment include effects on time in range, glucose variability, treatment satisfaction, well-being and weight over 26 weeks of treatment. Need of adding glucose lowering medications will also be compared between the treatment groups. An extension period will exist between 26 and 70 weeks. Between 26-52 weeks both groups will use only capillary testing for glucose monitoring and during 53-70 weeks the group initially randomized to capillary testing will use CGM. During the extension period similar variables will be evaluated as during the main phase of the trial including HbA1c, CGM-metrics, glucose-lowering medications, physical activity, treatment satisfaction and well-being.
In total 238 patients will be included in this study, carried out at 30 health care centres in Sweden
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 2 diabetes
- •Adults 18 years or older
- •Written Informed Consent
- •HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard) and less than 100 mmol/mol
- •Type 2 diabetes diagnosis <4 weeks
- •Body mass index > 25 kg/m2
排除标准
- •Pregnancy or planned pregnancy for the study duration
- •Type 1 diabetes
- •Judged to be in need of insulin
- •Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
- •History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
- •Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- •Participation in another study.
- •Other investigator-determined criteria unsuitable for patient participation.
结局指标
主要结局
HbA1c
时间窗: 6 months
Differences in changes in HbA1c between the CGM and SMBG group.
次要结局
- Well-being(6 months, 52 and 70 weeks)
- Glucose variability(6 months, 52 and 70 weeks)
- Treatment satisfaction(6 months, 52 and 70 weeks)
- Weight(6 months, 52 and 70 weeks)
- Time in range (TIR)(6 months, 52 and 70 weeks)