Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Mean Daily BG Levels
研究概览
简要总结
The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.
详细描述
The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
- •Known history of Type 2 diabetes mellitus for >3 months
- •Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
- •Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis
排除标准
- •Hyperglycemia without a history of diabetes
- •Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
- •Subjects receiving continuous insulin infusion
- •Clinically relevant hepatic disease
- •Corticosteroid therapy
- •Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30
- •Subjects unable to sign consent
研究组 & 干预措施
Insulin Aspart for BG > 140 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
干预措施: Insulin glargine (Drug)
Insulin Aspart for BG > 140 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
干预措施: Insulin aspart (Drug)
Insulin Aspart for BG > 140 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.
干预措施: Supplemental insulin aspart (Drug)
Insulin Aspart for BG > 260 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
干预措施: Insulin glargine (Drug)
Insulin Aspart for BG > 260 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
干预措施: Insulin aspart (Drug)
Insulin Aspart for BG > 260 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
干预措施: Supplemental insulin aspart (Drug)
结局指标
主要结局
Mean Daily BG Levels
时间窗: 5 days (average time of discharge from the hospital)
Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.
次要结局
- Mean Blood Glucose Levels at Bedtime(5 days (average time of discharge from the hospital))
- Mean Blood Glucose Levels Before Dinner(5 days (average time of discharge from the hospital))
- Mean Blood Glucose Levels Before Lunch(5 days (average time of discharge from the hospital))
- Number of Hypoglycemia Events(5 days (average time of discharge from the hospital))
- Average Number of Days of Hospital Stay(5 days (average time of discharge from the hospital))
- Number of Blood Glucose Readings Within 100-140 mg/dL Range(5 days (average time of discharge from the hospital))
- Incidence of Hyperglycemia(5 days (average time of discharge from the hospital))
- Mortality(5 days (average time of discharge from the hospital))
- Number of Subjects That Experienced Hospital Complications(5 days (average time of discharge from the hospital))
- Mean Daily Dose of Insulin(5 days (average time of discharge from the hospital))
研究者
Priyathama Vellanki
Assistant Professor
Emory University