Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments, by Means of a Designated Nutritional Care Program
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Total number of patients with at least 1 documented low (equal or below 70 mg/dL) glucose levels
研究概览
简要总结
This is a prospective randomized study to evaluate the efficacy of nutritional intervention for the prevention of hypoglycemia among diabetes patients with low albumin level that are admitted to internal medicine units, regardless of the reason for admission. All patients suitable for participation in the study will be asked to participate and be randomized to the interventional arm or the control arm.
After admission to the internal medicine unit, eligible patients will be asked to participate in the study. After signing an informed consent form, patients will be randomized to the treatment or control arms. For patients allocated to the treatment arm, the physician in charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The nurse in charge of the patient (at either the morning or evening shifts) will make sure the patient is receiving and consuming the ONS.
For every patient included in the interventional arm, 2 bottles of GlucernaTM will be supplied to the patient, one at 08:00 with the morning medications, and one at 16:00 with the evening medications. For clarification purposes, the GlucernaTM will be supplied on top of the designated meal plan, as "over-feeding". Evaluation of adequate ONS consumption will be performed 2-3 hours after the dispensing of the ONS (at 10:00-11:00 and 19:00-21:00), and the amount consumed will be documented.
Patients in the control arm will receive no oral nutritional supplementation, and their caloric intake will be composed of the food supplied by the hospital. Other analysis will be considered usual care. Additional diet consultations as requested by the medical staff will constitute usual care, and the patient will continue the study.
The duration of ONS treatment will be the entire length of hospital stay. Upon discharge, a recommendation to continue nutritional care will be added to the patients' discharge letters but no oral nutritional supplement (ONS) will be prescribed or dispensed.
Following discharge, a 30-day follow-up call will be made to ascertain whether the patient is alive, whether the patient was re-admitted or re-hospitalized, and the usage of ONS prescribed by the family/general practitioner that was consumed after the hospital discharge.
详细描述
1.2 Definitions: A. Hypoglycemia: a blood glucose level of 70 mg/dL or lower, regardless of symptoms B. Hypoalbuminemia: Albumin level below 3.5 g/dL upon admission to the hospital C. Adequate nutritional consumption: the consumption of at least half of the oral nutritional supplements D. Target population: Diabetes patients admitted to internal medicine units that have baseline hypoalbuminemia upon admission.
This is a prospective randomized study to evaluate the efficacy of nutritional intervention for the prevention of hypoglycemia among diabetes patients with low albumin level that are admitted to internal medicine units, regardless of the reason for admission. All patients suitable for participation in the study will be asked to participate and be randomized to the interventional arm or the control arm.
After admission to the internal medicine unit, eligible patients will be asked to participate in the study. After signing an informed consent form, patients will be randomized to the treatment or control arms. For patients allocated to the treatment arm, the physician in charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The nurse in charge of the patient (at either the morning or evening shifts) will make sure the patient is receiving and consuming the ONS.
2.3 Study population: All adult patients admitted to internal medicine units of the Wolfson Medical Center that will participate in the study. The admission to the unit can be either from the ER or as a transfer from other departments in the hospital.
Inclusion and Exclusion criteria specified above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •admission to internal medicine units &
- •Diabetes mellitus type 2 &
- •Admission serum-albumin level below 3.5 gr/dL.
排除标准
- •nasogastric [NG] tube
- •percutaneous endoscopic gastrostomy [PEG]
- •feeding jejunostomy
- •total parenteral nutrition [TPN]
- •chemotherapy or immunotherapy for malignancy during the past 6 months
- •Malignancy with life expectancy of less than 6 months
结局指标
主要结局
Total number of patients with at least 1 documented low (equal or below 70 mg/dL) glucose levels
时间窗: During the entire hospital stay, estimated up to 60 days
The number of patients with at least 1 documented glucose levels equal or below 70 mg/dL for the entire study arm
次要结局
- In-hospital and 30-day mortality rates(Estimated up to 90 days)
- Total number of documented low (equal or below 70 mg/dL) glucose levels(During the entire hospital stay, estimated up to 60 days)
- Length of hospital stay(During the entire hospital stay, estimated up to 60 days)
- 30-day readmission rate(During the first 30 days from discharge)
研究者
Eyal Leibovitz
Chair, Internal medicine unit B, Laniado hospital
Yoseftal Hospital