Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- Mean Fasting Blood Glucose
研究概览
简要总结
Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting information on BG levels at different time points during the day in order to assess glycemic control and to guide insulin adjustment/correction doses. Although POC testing provides insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of insulin supplements that may result in increased frequency of hypoglycemia and is expensive with an estimated annual cost in hospitals of several hundreds of millions of dollars in the U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin supplementation (correction doses) at bedtime in improving glycemic control and in preventing hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU medical and surgical patients treated with basal bolus regimen will undergo POC testing before meals and bedtime (standard of care) and half of the patients will receive insulin correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol, while the other half will be followed without insulin supplementation at bedtime except for extreme hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University Hospital and Grady Memorial Hospital.
详细描述
The value of POC testing and use of insulin supplements (correction doses) in particular at bedtime, has not been prospectively evaluated in insulin-treated patients with T2DM. In the non-ICU setting, practice guidelines for the management of hyperglycemia in patients with T2DM favor the use of physiologic (basal-nutritional-correction dose) insulin regimens over sliding scale regular insulin. POC testing is invasive and painful, and has the limitation of providing glycemic profile that is an incomplete picture of BG excursions and is not always an accurate method to monitor glucose compared to laboratory assays in addition to the major expense in health care delivery. The overall objective of this proposal is to conduct the first prospective randomized controlled trial (RCT) to determine the POC glucose testing and use of insulin supplementation at bedtime in improving glycemic control and in preventing hypoglycemia in insulin-treated non-ICU patients with T2DM. The central hypothesis of this proposal is that routine BG measurement and insulin supplementation at bedtime does not improve glycemic control or reduce frequency of hypoglycemia in insulin treated medicine and surgery patients with T2DM.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a known history of T2DM for > 3 months
- •Age 18-80 years
- •Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
- •BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis
排除标准
- •Hyperglycemia without a history of diabetes
- •Acute critical illness admitted to the ICU or expected to require ICU admission
- •Receiving continuous insulin infusion
- •Clinically relevant hepatic disease
- •Patients on corticosteroid therapy
- •Patients with creatinine ≥ 3.5 mg/dl
- •Subjects unable to sign consent
研究组 & 干预措施
Bedtime supplementation
Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
干预措施: Bedtime insulin Aspart (Novolog) (Drug)
结局指标
主要结局
Mean Fasting Blood Glucose
时间窗: up to 10 days
The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.
次要结局
- Length of Hospital Stay(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Hospital Mortality(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Pneumonia(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Bacteremia(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Mean Daily BG(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Number of Hypoglycemia (BG < 70 mg/dl)(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl](participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Daily Dose of Insulin(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Nosocomial Infections (CDC)(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days(daily while in hospital for up to 10 days)
- Number of BG Within Target(Participants will be followed over the hospital stay- expected 6 days.)
- Number of Subjects With BG > 300 mg/dL(Subjects will be followed over the hospital stay: expected 6 days)
研究者
Guillermo Umpierrez
Prinicipal Investigator
Emory University