Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- TIme in range
研究概览
简要总结
The aim of the study is to investigate the efficacy and safety of premixed insulin treatment in patients With type 2 diabetes mellitus using professional and personal Flash Glucose Mornitoring.
详细描述
Professional and personal Flash Glucose Mornitoring will be used in patients with type 2 diabetes who are treated with premixed insulin. The frequency of hypogycemia and the blood glucose control will be analyzed by flash glucose mornitoring once a month for 3 months and doctors will adjust the hypoglycemia treatment according to the results every month. HbA1c, glycemic variation, beta-cell function and androgen levels will be measured.
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
- Double (Investigator, Outcomes Assessor)
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
- •participate voluntarily and sign the subject informed consent before the test.
- •for patients with type 2 diabetes who met WHO1999 diagnostic criteria, subcutaneous injection with premix insulin Bid/Tid, single drug and/or combination of oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months.
- •no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
- •subjects are able and willing to undergo FGM examination, diet and exercise regularly.
排除标准
- •patients treated with GLP-1 agonist in the last 3 months
- •patients who are allergic to insulin.
- •impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- •a history of drug abuse and alcohol dependence within the past 5 years.
- •used systemic hormone therapy in recent 3 months.
- •patients with poor compliance and irregular diet and exercise.
- •patients with infection and stress within four weeks.
- •patients who cannot tolerate flash glucose mornitoring.
- •patients who are pregnant, nursing or or preparing to become pregnant.
- •any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
研究组 & 干预措施
Professional flash glucose mornitoring
Professional flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level. Patients can learn their blood glucose levels via capillary blood glucose tests, but nor FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring.
干预措施: Professional flash glucose mornitoring (Device)
Personal flash glucose mornitoring
Personal flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level. Patients can learn their blood glucose levels via FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring.
干预措施: Personal flash glucose mornitoring (Device)
结局指标
主要结局
TIme in range
时间窗: baseline and after 3 month
change of TIme in range
次要结局
- HbA1c(after 3 month)
- antibody of insulin(baseline and after 3 month)
- angrogen levels(baseline and after 3 month)
- exercise time daily(baseline and after 3 month)
- meal times(baseline and after 3 month)
- calorie intake(baseline and after 3 month)