Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference in mean glucose levels between subjects in intervention vs control group
研究概览
简要总结
The purpose of this research is to prove that data generated by your real-time personal continuous glucose monitors CGMs brought in the hospital at the time of hospitalization can be monitored and safely used to guide insulin therapy aiming to improve glycemic control and to diminish the hypoglycemia and hyperglycemia episodes without negatively affecting patients' satisfaction, providers and your nurses satisfaction with how glucose is monitored and treated in the hospital.
详细描述
This study will be a single center, randomized, unblinded, prospective, crossover, 2 arm, pilot study. The study will compare the glucose control in hospitalized patients with diabetes mellitus on insulin therapy and wearing a personal CGM when the CGM data will be continuously accessed versus glucose control for hospitalized patients not having the CGM data continuously accessed and receiving inpatient standard of care for diabetes mellitus.
Population:
Adult patients with diagnosis of diabetes mellitus, receiving subcutaneous insulin therapy in the hospital or in the home hospital program - Advanced Care at Home Program (ACH) and wearing a personal real time CGM at the time of admission.
Eligible subjects will be identified and will be approached for enrollment in person by the research coordinators. After enrollment they will be randomized in 2 arms: intervention and control arms.
Both intervention and control arm subjects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with ages above 18 years old at the time of informed consent.
- •Male or female
- •Admitted to non-ICU setting in brick-and-mortar medical and surgical ward or admitted to Advanced Care at Home Program.
- •Admitted under observation or inpatient status.
- •Expected to remain in the hospital for more than 48 hours.
- •Patients that are using a transcutaneous or implantable real time CGM as outpatient and are bringing it to the hospital.
- •Patients with diagnosis of diabetes mellitus or hyperglycemia requiring treatment with SQ insulin in the hospital either with multiple daily injections or subcutaneous infusion of insulin via insulin pump.
排除标准
- •Participants unable to provide informed medical consent.
- •Participants admitted to Intensive Care Units (ICU). Enrollment is possible after transferring out of the ICU.
- •Actively being treated for DKA (diabetes ketoacidosis) or HHS (hyperosmolar hyperglycemic state)
- •Patients with a diagnosis of liver cirrhosis.
- •Patients with a diagnosis of ESRD or Acute Renal Failure on hemodialysis or peritoneal dialysis.
- •Patients with planned MRI or surgical procedure. Enrollment is possible after MRI or surgery.
- •Participants with allergy to medical grade adhesive or medical tape.
- •Participants who are pregnant, wanting to become pregnant, or nursing during study period.
- •Participants using Medtronic and Dexcom sensors and taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
- •Participants using Dexcom sensors and taking hydroxyurea.
- •Participants using Libre sensors and taking over 500 mg of ascorbic acid.
- •Patients using Eversense sensors and taking tetracycline type of antibiotics.
- •Participants actively enrolled in other studies addressing their CGM use unless express permission is obtained from prior study research team principal investigator or co-principal investigator.
研究组 & 干预措施
Control
patients admitted to the hospital wearing a CGM with data not monitored in real time
干预措施: Share CGM data on admission and on discharge from the hospital (Device)
Monitored
patients admitted to the hospital wearing a CGM with data monitored in real time
干预措施: Real time CGM data monitoring (Device)
Monitored
patients admitted to the hospital wearing a CGM with data monitored in real time
干预措施: Insulin dose adjustment based on glucometer and CGM glucose data trends (Device)
Monitored
patients admitted to the hospital wearing a CGM with data monitored in real time
干预措施: Share CGM data on admission and on discharge from the hospital (Device)
结局指标
主要结局
Difference in mean glucose levels between subjects in intervention vs control group
时间窗: From admission date to discharge date up to 8 weeks.
Difference in mean glucose levels between subjects in intervention vs control group
Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts
时间窗: From admission date to discharge date up to 8 weeks.
Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts
次要结局
- Measure subjects perceived satisfaction with CGM inpatient monitoring(At the time of discharge date assessed up to 8 weeks.)
- Difference in Time Below Range <54 mg/dl and Time Below Range <70 mg/dl between subjects in intervention and control cohorts(From admission date to discharge date up to 8 weeks.)
- Difference in Time Above Rance >180 mg/dl and Time Above Rance >250 mg/dl between subjects in intervention and control cohorts.(From admission date to discharge date up to 8 weeks.)
研究者
Adrian G. Dumitrascu
Principal Investigator
Mayo Clinic