RAndomized SubCutaneous Insulin in INpatients (RASCIN) Trial: Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Length of Hospitalization Stay
研究概览
简要总结
The purpose of this study is to determine whether aggressive (goal pre-prandial blood glucose <110 mg/dl) versus conservative (goal pre-prandial blood glucose <180mg/dl) diabetes treatment of type 2 diabetic patients on the general medical wards has any effect on hospital outcomes.
详细描述
Objective: The objective of this study is to determine the effect of an "aggressive" blood glucose control (goal pre-prandial CBG <110 mg/dl) versus a "conservative" blood glucose control (goal pre-prandial CBG <180 mg/dl) on length of stay in hospitalized type 2 diabetic patients using levemir (detemir) and novolog (aspart) insulins.
Study Site: Parkland Memorial Hospital, 5201 Harry Hines Blvd, Dallas, Texas 75235. Parkland Hospital is a 720 adult bed public hospital that serves as the main teaching hospital for the University of Texas-Southwestern Medical Center. In addition, Parkland Memorial Hospital possesses the University Diabetes Treatment Center, an eleven bed medical ward devoted to inpatient diabetes management. This study will be conducted throughout all of Parkland's general medical floors, including the University Diabetes Treatment Center.
Patient Population: The population for this study includes men and women with type 2 diabetes admitted to the general medicine wards of Parkland Memorial Hospital.
Study Design and Duration: This is a single-center, randomized, single blind, non-inferiority study design.
Patients admitted to Parkland Hospital with type 2 diabetes will be recruited to the study within 24 hours of admission. Gravid patients, patients in DKA, or HHS will be excluded. All patients will be evaluated for inclusion and exclusion criteria. During the hospitalization, patients will be stratified by age and admitting diagnosis and randomized to either an "aggressive" blood glucose control (goal pre-prandial CBG <110 mg/dl) or a "conservative" blood glucose control (goal pre-prandial CBG <180 mg/dl). Subcutaneous detemir and novolog will be employed according to the enclosed protocol to meet the goal blood glucose level. The insulin will be administered by nursing staff via the FlexPen, a pre-filled pen-like insulin delivery device. CBGs will be obtained before breakfast, before lunch, before supper, and at bedtime. If a patient is NPO, then the CBGs will be obtained at the time that the patient was to have eaten.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing diagnosis of type 2 diabetes.
- •Admitted to a non-telemetry, non-ICU medicine inpatient bed.
- •Willing and able to give informed consent.
- •HgbA1c of any value will be accepted.
排除标准
- •Type 1 diabetes
- •Admitted to a telemetry, ICU, or non-medicine inpatient bed (e.g., surgery, neurosurgery, obstetrics/gynecology, psychiatry).
- •Diabetic ketoacidosis (arterial ph <7.24, serum bicarbonate <15, positive serum ketones, anion gap >12)
- •Hyperosmolar hyperglycemic state (blood glucose >200 mg/dl, serum osmolarity >320 mOsm/kg)
- •Inability to cooperate with study personnel.
- •Known allergy or intolerance to detemir or novolog.
- •Admission to the hospital >24 hours from entry into the study.
- •Admission to the hospital for inpatient hospice care.
- •Admission/continued admission to the hospital for procurement of a guardian.
- •Admission/continued admission to the hospital for rehabilitation.
- •Patients admitted with the diagnosis of acute coronary syndrome.
- •Patients admitted with the diagnosis of acute cerebrovascular accident.
- •Patients currently pregnant or breast-feeding.
- •Patients not fluent in English or Spanish as it will be difficult to obtained written informed consent in another language.
研究组 & 干预措施
Conservative Blood Glucose Control
Goal Pre-prandial blood glucose <180 mg/dl.
干预措施: Levemir (Detemir) and Novolog (Aspart) Insulin (Drug)
Aggressive Blood Glucose Control
Pre-prandial goal blood glucose <110 mg/dl
干预措施: Levemir (Detemir) and Novolog (Aspart) Insulin (Drug)
结局指标
主要结局
Length of Hospitalization Stay
时间窗: 18 months
次要结局
- All-Cause Mortality(18 months)
- Cost of Hospitalization(18 months)
- Frequency of Hypoglycemic Episodes(18 months)
- Rate of Transfer to Telemetry Unity(18 months)
- Rate of Surgical Procedures(18 months)
- Rate of Re-hospitalization(18 months)
- Time to goal blood glucose level(18 months)
- Time to becoming medically stable for discharge(18 months)
- Rate of Nosocomial Infections(18 months)