Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
研究概览
简要总结
This program will provide patients with type 1 and high risk type 2 diabetes the safest hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their glucose parameters in real-time similar to other continuously monitored vital signs. The CGM will inform a team of health professionals who will monitor the patients' progress, communicate recommendations, and be available for discussion when recommended targets are not achieved. Health teams will utilize sensor results in addition to existing electronic medical records data to evaluate progress and manage care.
详细描述
All patients with type 1 or type 2 diabetes who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by an advanced practice diabetes nurse for glucose management during their hospitalization. All patients included in the study will receive a CGM. Patients with type 2 diabetes will be randomized to control (blinded CGM glucose values to APN, care team and researchers) or intervention (CGM blood glucose values will be used to aid with glucose management during the hospitalization). In addition, a research only supplemental order set will be implemented for all study participants. The order set focuses on any glucose point of care test that is between 70-79 mg/dL or ≥ 250 at bedtime or before the 4 am usual care blood glucose check. The goal is to prevent hypoglycemia and hyperglycemia for all study patients. The advanced practice diabetes nurse will work with the physician in charge of the patient's care as well as the patient's care team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Expected length of hospital stay of at least 48 hours
- •One of the following:
- •Diagnosed with diabetes type 1 OR
- •Diagnosed with diabetes type 2, with an HbA1c > 8% or 3 point-of-care blood glucose (POC) > 200, and requiring insulin during this hospitalization.
- •Literate in English or Spanish
排除标准
- •(not all listed):
- •Pregnant or post-partum
- •Patient admitted to OB unit
- •Patient in ICU or with insulin drip
- •Known allergy to adhesives
- •Anticipated CT/MRI/diathermy procedure within 48 hours from admission (patients with a planned operation within 48 hours from admission may be included in the study post operation).
结局指标
主要结局
Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
时间窗: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL
Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL)
时间窗: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL
Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL)
时间窗: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL
次要结局
- Percentage Time in Hypoglycemia (<70 mg/dL)(Up to 30 days)
- Percentage Time in Hyperglycemia (>250 mg/dL)(Up to 30 days)
研究者
Athena Philis-Tsimikas
Corporate Vice President
Scripps Whittier Diabetes Institute