A Prospective Investigation Into the Causes, Symptoms, and Outcomes in Patients With Diabetes Who Experience Hypoglycemia During Their Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores
研究概览
简要总结
Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at risk for losing the ability to develop symptoms that warn them that they are having a low blood sugar. There is almost no available information investigating how the inability to feel symptoms of a low blood sugar contributes to the risk of this happening when people with diabetes are hospitalized. The purpose of this study is to develop a symptom score model that will help to identify patients at risk for low blood sugars in the hospital and to examine what happens to patients who do experience a low blood sugar in the hospital.
详细描述
Patients who develop recurrent hypoglycemia are predisposed to developing hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no information investigating the contribution of HAAF as a risk factor for hypoglycemia in hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic symptom score model to examine HAAF and its correlation with cognitive dysfunction, re-hospitalization rates, inpatient morbidity and mortality.
This will be a prospective non-blinded study performed in a tertiary care center that will include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (< 40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing within 24-36 hours post event. Participants will be contacted at 6 and 12 months following the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia, need for re-hospitalization, and occurrence of any new diabetes related complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes
- •Non-critically ill hospitalized surgical and medical patients
- •Anticipated length of stay (LOS) >3 days
- •Anticipated life expectancy > 1 year
- •Mentally competent individuals
排除标准
- •Patients who are admitted for hypoglycemia or Diabetic Ketoacidosis
- •Anticipated LOS <3 days
- •Mentally incompetent individuals defined as any patient with evidence of dementia or delirium recorded in their medical history or progress note
- •Patients receiving Total Parenteral Nutrition
- •Treatment with high dose narcotic medications
- •Patients who would not be able to follow up at 3 to 6 and 9-12 months by telephone call
- •Patients with expected life expectancy < 1 year
结局指标
主要结局
Prevalence of Hypoglycemia Associated Autonomic Failure in the inpatient setting as assessed by hypoglycemia symptom scores
时间窗: Within 24-36 hours following a hypoglycemia event.
Hypoglycemia Symptom Score Questionnaires will be administered to participants in time frame described. These questionnaires include a list of potential autonomic and neuroglycopenic symptoms that can occur in response to hypoglycemia.
次要结局
- Measures of cognitive function following a hypoglycemic event(Within 24 to 36 hours of a hypoglycemia event.)
研究者
Mary Korytkowski
Professor of Medicine
University of Pittsburgh