Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control
Mayo Clinic
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with ages above 18 years old at the time of informed consent. 2. Male or female 3. Admitted to non-ICU setting in brick-and-mortar medical and surgical ward or admitted to Advanced Care at Home Program. 4. Admitted under observation or inpatient status. 5. Expected to remain in the hospital for more than 48 hours. 6. Patients that are using a transcutaneous or implantable real time CGM as outpatient and are bringing it to the hospital. 7. Patients with diagnosis of diabetes mellitus or hyperglycemia requiring treatment with SQ insulin in the hospital either wit…
Interventions
- DeviceReal time CGM data monitoring
CGM data will be monitored in real time during daytime in the hospital. Alerts about high and low glucose levels will be communicated to patient's nurse and treating providers.
- DeviceInsulin dose adjustment based on glucometer and CGM glucose data trends
Insulin dose will be modulate based on glucometer values and previous day glucose trends as recorded on CGM.
- DeviceShare CGM data on admission and on discharge from the hospital
Record 14 days' worth of CGM data prior to admission and all CGM data recorded during the hospitalization at the time of discharge from the hospital
Location
- Mayo Clinic in FloridaJacksonville, Florida