Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hba1c reduction
研究概览
简要总结
Introduction Diabetes mellitus is a worrying global non-communicable disease where it is affecting 18.3% of Malaysian adults. Poorly managed diabetes leads to an array of serious complications, namely heart attack, kidney failure and stroke. Insulin therapy remains one of the most important medication in treating diabetes especially in the population with high sugar readings or long standing diabetes. Outpatient consultations for T2DM patients are spaced out due to the limited amount of treating physicians and clinic time. This resorts to the importance of outpatient patient-lead insulin titration. Different guidelines from local and international showed different basal insulin titration method in achieving ideal fasting blood sugar.
Objective We aim to investigate the difference of basal insulin titration methods in reducing HbA1c among the T2DM patients.
Methodology In a parallel group randomized controlled trial, we aim to recruit 70 adult T2DM patients who have poorly controlled T2DM ( HbA1c > 7.5% with FPG >8mmol/L) or newly diagnosed T2DM patients (who are symptomatic or HbA1c >10% or FPG >13 mmol/L). The subjects will be randomized to 2 groups, daily basal insulin titration and 3 daily basal insulin titration. These subjects will be follow up for 12 weeks (4th week and 8th week virtual consultation and 12th week face-to-face consultation). The primary outcome is the HbA1c reduction from baseline to the end of 12weeks intervention. The secondary outcomes are percentage of T2DM patients achieving fasting blood sugar within 4.4-7mmol/L and/or HbA1c <7% within the study period, the incidence of hypoglycemia, total daily basal insulin dosage required to achieve desired fasting blood sugar, duration taken to achieve desired fasting blood sugar, weight changes and satisfaction to the therapy between the 2 intervention groups.
Clinical Significance This study enables us to evaluate the efficacy of the different basal insulin titration methods among the T2DM patients.
详细描述
Hypothesis Daily basal insulin titration reduces HbA1c more significantly compared with 3 daily basal insulin titration among T2DM patients.
Aims
Primary Aim :
To evaluate the difference of daily basal insulin titration method and 3-daily basal insulin titration method in reducing HbA1c among T2DM patients
Secondary Aim :
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus patients with
- •Adults aged 18 years and above
- •HbA1c >7.5% and Fasting blood sugar > 8mmol/L
- •Newly diagnosed T2DM with osmotic symptoms or HbA1c >10% or FPG >13mmol/L
- •Insulin naïve patients
- •Patients planned for insulin initiation
- •Ability to give informed consent
- •Ability to perform self-monitoring blood glucose
排除标准
- •Diabetes other than type 2 diabetes mellitus
- •Diabetes in pregnancy
- •Diabetes with chronic kidney disease stage 3,4 and 5 (eGFR <60ml/min/1.73m2)
- •Patient with history of severe hypoglycemia
- •Active proliferative diabetic retinopathy
- •Any medical condition that may influence HbA1c measurements (e.g., thalassemia, sickle cell anemia)
- •Treatment with systemic corticosteroid
研究组 & 干预措施
Daily basal insulin titration
Participants in this intervention arm will be started with basal insulin of 10 units or 0.2 unit/kg (whichever lower) at pre-bed time. They will then check their morning fasting CBG the following day. If they have no hypoglycemia symptoms or documented hypoglycemic CBG (<3.9mmol/L), and their fasting CBG is more than 7mmol/L, they will then self-titrate their basal insulin by 1 unit (ie 10+1) the following night. This same process is going to be repeated until their fasting CBG achieve 7mmol/L or lower. Then, they will continue and maintain on the desired basal insulin dosage till their appointment. The maximum basal insulin that is allowed to be titrated by the participants is up to 0.5unit/kg. Participants are required to document down their CBG and any hypoglycemia symptoms in a simple table method provided to them
干预措施: NPH basal insulin titration (Drug)
3 daily basal insulin titration
Participants in this intervention arm will be started with basal insulin of 10 units or 0.2 unit/kg (whichever lower) at pre-bed time. They will then check their morning fasting CBG the following 3 days. If they have no hypoglycemia symptoms or documented hypoglycemic CBG (<3.9mmol/L), and their fasting CBG is more than 7mmol/L (for 2 out of 3 days), they will then self-titrate their basal insulin by 2 units (ie 10+2) on the 3rd night. This same process is going to be repeated until their fasting CBG achieved 7mmol/L or lower. Then, they will continue and maintain on the desired basal insulin dosage till their appointment. The maximum basal insulin that is allowed to be titrated by the participants is up to 0.5unit/kg. Participants are required to document down their CBG and any hypoglycemia symptoms in a simple table method provided to them.
干预措施: NPH basal insulin titration (Drug)
结局指标
主要结局
Hba1c reduction
时间窗: 3 months
To compare the HbA1c reduction of the daily basal insulin titration arm with the 3-daily basal insulin titration arm
次要结局
- Hypoglycemia frequency(3 months)
- Basal insulin required to achieve fasting blood sugar less than 7mmol/L(3 months)
- Satisfaction of titration(3 months)
- Duration to achieve fasting cappilary blood glucose less than 7mmol/L(3 months)
- percentage of subjects achieving fasting capillary blood glucose and/or hba1c below 7%(3 months)
- Weight changes after intervention(3 months)