Inpatient Self Monitoring and Administration Study (ISMAS)
试验速览
- 阶段
- 不适用
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- number of blood glucose measurements obtained/number of blood glucose measurements ordered
研究概览
简要总结
ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin.
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
- •Male or female, age < 80
- •Most recent hemoglobin A1C within the past 6 months < 12%
- •Recent history of regular self-administered peripheral blood glucose checks as an outpatient
- •Recent history of insulin self-administration at least twice a day as an outpatient
- •Admitted for a hospitalization anticipated to last at least 3 days
- •Mini Mental Status Examination (MMSE) ≥ 25 at admission and the same or better post-operatively
- •All patients will be actively followed by the Endocrinology inpatient consultation team during the hospitalization.
排除标准
- •Currently receiving peritoneal or hemodialysis
- •Patients with unstable angina
- •History of myocardial infarction within 3 weeks prior to enrollment
- •Current admission due to or associated with altered mental status or encephalopathy
- •History of an episode of altered mental status or encephalopathy within the 4 weeks prior to enrollment
- •A confirmed diagnosis of dementia
- •Inability to self-adjust insulin
- •No recent history of ability to perform regular peripheral blood glucose checks
- •Frequency of hypoglycemia (< 60 mg/dL) > twice/week by history
- •Inability to eat without assistance
- •Study objectives will not be pursued in patients during stays in any intensive care unit.
研究组 & 干预措施
Standard care
Patients admitted for elective surgery will receive standard diabetes care, including but not limited to finger stick blood glucose determinations, and insulin injections delivered by the nursing staff.
干预措施: Standard care (Procedure)
Patient administered care
Patients will self-monitor and record finger-stick blood glucose measurements, and self administer insulin at doses agreed upon with the consulting endocrinology in-patient service.
干预措施: Self blood glucose monitoring and insulin administration (Procedure)
结局指标
主要结局
number of blood glucose measurements obtained/number of blood glucose measurements ordered
时间窗: patients will be followed for the duration of hospital stay, an expected average of 5 days
number of insulin doses administered/number of insulin doses prescribed
时间窗: patients will be followed for the duration of hospital stay, an expected average of 5 days
average blood glucose
时间窗: patients will be followed for the duration of hospital stay, an expected average of 5 days
次要结局
未报告次要终点
研究者
Peter Thule
Chief, Section Endocrinology
Atlanta VA Medical Center