Daibetes Discharge Transitional CGM Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Emergency room visit and rehospitalization
研究概览
简要总结
Intervention group will receive brief diabetic education, CGM education and use and have a CGM placed before discharge. They will also sign up for "Cloud" access of their CGM data. A medical assistant will review their CGM data daily to make sure they are using the CGM adequately. The principal investigator will review the CGM data and call the patient for a brief phone evaluation of their glucoses and their transition from the hospital to outpatient care. The will be called 4 times between discharge and day 15 by the principal investigator.
Standard treatment group will receive a blinded CGM to be reviewed 30 days after discharge.
Reduction in hospitalizations and ER visits within the first 30 days is the primary outcome. Time in range, hypoglycemia, hyperglycemia and patient satisfaction will also be evaluated 30 days after discharge.
详细描述
Patients admitted to a community hospital with diabetes will be evaluated for being high risk for rehospitalization. High risk patients will be identified and those that are found to be high risk will be evaluated for entrance to the study and consented.
Those that consent will be randomized to two arms, an intervention arm and a standard care arm with CGM monitoring.
Intervention will include a brief 15 minute diabetic education session and a 15 minute brief education on how to use the Freestyle Libre CGM. A sensor will be placed and initiated before discharge. They will also sign up for a Freestyle Libre View account and grant access to the intervention team. The will receive a handout of reasons to call the principal investigator during the first 15 days and will be told to access the PI through the hospital operator. The PI will call the patient on day 3-4, day 5-6, day 9-10 and day 14-15 after reviewing their CGM data. The PI will review their glucoses and also any concerns from their hospitalization. The team can then help bridge any treatment or care gaps with the patients PCP or care team. The CGM data will be recorded for the first 14 days and data will be sent to the PCP.
The standard treatment arm will get 15 minutes of education on how to use the Libre Pro blinded CGM sensor and the sensor will be placed before discharge. The sensor will be sent back the the team and downloaded. After 30 days the data will be sent to the patients PCP.
Outcomes will be measured for 30 days from discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data evaluation group will be blinded as to which arm the data comes from
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes plus one additional criteria during hospitalization:
- •A1C greater than or equal to 9, New diagnosis of diabetes Type 2 and A1C greater than or equal to 8, On insulin, On sulfonylurea, Deemed to by high risk by hospitalist staff for post-hospitalization complications, Acute Heart Failure, Acute Coronary Syndrome (ACS), Stroke, or a TIA.
排除标准
- •Type 1 Diabetes, or Not high risk (as above), or Already using a CGM, or Unable to understand or use a CGM, or Unable or unwilling to use a CGM, or Participating in another clinical trial within 30 days.
研究组 & 干预措施
Standard Care
A blinded CGM will be placed to review glucoses after discharge in the Standard Care arm.
Diabetic education and CGM monitoring
Treatment arm will get diabetic education, active CGM use with patient feedback for 14 days, active access to the PI for concerns relating to hospitalization. They will also receive a brief, 15 minute phone call from the PI on day 3-4, 6-7, 9-10 and day 14-15.
干预措施: CGM device with diabetic education, CGM education and a follow up protocol. (Device)
结局指标
主要结局
Emergency room visit and rehospitalization
时间窗: Within 30 days after discharge from the hospital
Total Emergency room visits and total rehospitalizations
次要结局
- Time in range(From discharge to day 14)
- time in severe hyperglycemia(from discharge through day 14)
- Patient satisfaction(survey will be done between 31 and 40 days after hospital discharge)
- time in hypoglycemia(from discharge through day 14)
- Severe hypoglycemia(from discharge to day 30)
- Emergency room visits(Within 30 days after discharge from the hospital)
- Rehospitalizations(Within 30 days after discharge from the hospital)
- time in hyperglycemia(From discharge through day 14)
研究者
Christopher Jones
Principal Investigator
Intermountain Health Care, Inc.