Glucose Monitoring After Acute Myocardial Infarct in People With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Primary outcome: Percent time spent in glucose target range (3.9-10mmol/L)
研究概览
简要总结
Glucose monitoring after Acute Myocardial infarct in people with diabetes is a Dexcom funded study that is investigating whether the use of continuous glucose monitors (Dexcom ONE model) in people with type 2 diabetes facilitates time in glycaemic range in the 6 months after an acute myocardial infarction. As an exploratory outcome it will investigate whether time in glycaemic range is associated with changes in mortality and major adverse cardiac events in the 6 months after acute myocardial infarct.
详细描述
The study
- Patients recruited from cardiology services after ACS (n=140 participants)
Following informed consent study participants with known diabetes who have had an acute myocardial infarct will be recruited. Participants will be randomly allocated to either the intervention group, referred to as cohort 'a', or to the control group, referred to cohort 'b'. They will be randomised using permuted blocks in a 5:2 ratio (intervention:control). CGM (real-time or blinded) will be applied to participants prior to discharge.
Following hospital discharge, the effects of changes in blood glucose levels on cardiac and health outcomes will be evaluated. Participants recruited to cohort 'a' will wear real-time CGM continuously after hospital discharge for 26 weeks. They will have face-to-face, telephone or video reviews of CGM data at 4 and 12 weeks with clinician-led diabetes treatment escalation according to NICE guidelines based aiming for >70% time in target blood glucose range, 3.9-10mmol/L (50% for older or high risk individuals). Participants recruited to cohort 'b' will wear blinded CGM for 10 days after insertion. They will wear blinded CGM again for 10 days , with the second sensor insertion at days 17-23, third sensor insertion during week 10 and fourth sensor insertion during week 24. Following each sensor wear, participants in cohort 'b' will have a study visit when their sensor data will be downloaded. Participants in cohort 'b' will receive face-to-face or remote support to insert and establish blinded CGM but no clinical review and the participant should manage their diabetes as the participant normally would. At 26 weeks data will be analysed for all primary and secondary outcomes.
The participants who receive real-time CGM will be compared to age and sex-matched controls, who's data will be obtained from the NIHR Cardiovascular Health Informatics Collaborative for comparison of cardiovascular outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •From the Hammersmith Hospital In-patient Cardiology Services:
- •Adults aged >18 years
- •Known or newly diagnosed type 2 diabetes
- •Taking one or more oral hypoglycaemic agent, GLP1 receptor analogue and/or insulin
- •Admitted to Hammersmith Hospital cardiology inpatient services with ACS
- •Raised blood troponin level on admission
- •From Imperial College Healthcare Trust Diabetes and Cardiology Clinics:
- •Adults aged >18 years
- •Known type 2 diabetes
- •Previous acute coronary syndrome within the last 10 years but > 6 months ago
- •Taking one or more oral hypoglycaemic agent and /or GLP1 receptor analogue, and/or insulin
排除标准
- •From the Hammersmith Hospital In-patient Cardiology Services:
- •HbA1c <48mmol/mol
- •People who have previously had bariatric surgery
- •People taking hydroxyurea
- •People who undergo haemodialysis or peritoneal dialysis
- •Unable to participate due to other factors, as assessed by the Chief Investigators
- •Pregnancy as determined by clinical team
- •Known to have a terminal condition or conditions that suggest a life expectancy less than 1 year
- •From Imperial College Healthcare Trust Diabetes and Cardiology Clinics:
- •HbA1c <48mmol/mol
- •People who have previously had bariatric surgery
- •People taking hydroxyurea
- •People who undergo haemodialysis or peritoneal dialysis
- •Unable to participate due to other factors, as assessed by the Chief Investigators
- •Pregnancy as determined by clinical team
- •Known to have a terminal condition or conditions that suggest a life expectancy less than 1 year
- •Previous acute coronary syndrome more than 10 years ago or within the last 6 months
- •Withdrawal criteria
- •The subject has a serious event related to the study
- •Investigated initiated discontinuation of study due to participation or equipment concerns
- •Withdrawal of consent
结局指标
主要结局
Primary outcome: Percent time spent in glucose target range (3.9-10mmol/L)
时间窗: 26 weeks
Percent time spent in glucose target range (3.9-10mmol/L)
次要结局
- HbA1c at 12 weeks and 26 weeks.(26 weeks)
- Time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL; <3.0mmol/L, 54mg/dL),(26 weeks)
- Time in hyperglycaemia (>10mmol/L, 180mg/dL).(26 weeks)
- Hypoglycaemia requiring 3rd party assistance.(26 weeks)
- Low Blood Glucose Index (LBGI})(26 weeks.)
- Number hypoglycaemic excursions.(26 weeks)
- Time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL).(26 weeks)
- Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)(26 weeks)
- Glucose variability assessed by %Coefficient of Variation (%CV).(26 weeks)
- Mean Absolute Glucose (MAG)(26 weeks)
- Health and treatment-related quality of life measured by the Diabetes Treatment Satisfaction Scale score.(26 weeks)
- Hypoglycaemic symptoms(26 weeks.)
- Audit of Diabetes Dependent Quality of Life questionnaire domain.(26 weeks.)