Reducing E.D. Visits and Hospital Readmissions, and Improving Glucose Control of Patients With Uncontrolled Type 2 Diabetes by Use of Continuous Glucose Monitoring Sensors Placed at Hospital Discharge.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
Quality measures and cost-reduction methods are a high priority in the United States health care system. This includes the high burden of patients with uncontrolled Type 2 Diabetes. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on the system are a necessity. Use of FDA-approved continuous glucose monitoring (CGM) sensors have shown benefit in better management plans in the outpatient setting. Hence, this study hypothesizes that using CGM sensors starting in the inpatient setting will provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates. The study will randomly assign patients to either receive a CGM sensor plus the standard diabetes management and instructions or who will only receive the standard diabetes management. The patients will be followed in the outpatient endocrinology clinic 1-month, 3-month, and 6-month from the time of hospital discharge.
详细描述
Rationale: Quality measures and cost-reduction methods are a high priority in the United States health care system currently. This includes the high burden of patients with uncontrolled Type 2 Diabetes on the system especially given the continued dramatic rise in the prevalence of these patients. Innovative ways to better understand and implement diabetes management plans to reduce the burden of this disease on our health care system are a necessity. The use of continuous glucose monitoring (CGM) sensors have already shown benefit in better management plans in the outpatient setting. Hence, this study aims to assess the use of CGM sensors starting in the inpatient setting and whether they will help provide better and quicker understanding of the disease to make expedited changes to management plans thereby improving blood glucose control and mitigating some of the health care burden by means of reducing E.D visits and hospital re-admission rates.
Objectives: To determine whether the use of CGM sensors in patients with uncontrolled type 2 diabetes at the time of hospital discharge leads to improved glucose control and a reduction of E.D visits and hospital readmission rates.
Trial Design: The trial design will be a randomized, non-blinded prospective study; a 1:1 comparison of uncontrolled type 2 diabetes patients who receive CGM sensors + conventional diabetes management at the time of discharge versus uncontrolled type 2 diabetes patients who receive only the conventional diabetes management.
Study Setting: Study setting will be at the Albert Einstein Medical Center (AEMC), Philadelphia, Pennsylvania for the inpatient type 2 diabetes population who will be followed at the AEMC endocrinology clinics.
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 (Outcomes Assessor)
盲法说明
Statistical analysis to be performed on the primary and secondary outcome measure data will be provided to the assessor without information indicating whether or not a subject received the CGM sensor.
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
- •inpatient uncontrolled Type 2 Diabetes patients defined by HbA1c of ≥9.0% within the last 2-3 months
- •require an endocrinology consultation
- •will be followed at AEMC endocrinology clinic
排除标准
- •patients with HbA1c <9.0%
- •patients not managed by AEMC endocrinology clinic
- •Type 1 Diabetic patients
结局指标
主要结局
Change in HbA1c
时间窗: Measured at the 180-day interval post-intervention
The difference of the average changes in HbA1c from baseline between each group (intervention vs control)
# of E.D. visits
时间窗: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Number of ED visits after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
# od hospital re-admissions
时间窗: Within 30 days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
Number of hospital re-admissions after the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data
次要结局
- Time till first E.D. Visit(data collected for any visit occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data)
- Time till first hypoglycemic event(Data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data)
- Outpatient Visit Compliance(assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data)
- HbA1c <9.0% at the end of study(Assessed at the 180-day interval from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data)
- Diabetes Mellitus (DM) Management change based on CGM sensor/log data(assessed within 30 days from the time the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data)
- Severity of first hypoglycemic event(data collected for any event occuring within 180-days from the time of the first recommendation made by the clinician based on the CGM sensor data/blood glucose log data)
研究者
Catherine Anastasopoulou, MD, PhD, FACE
Endocrine Chair, Einstein Healthcare Network
Albert Einstein Healthcare Network