FreeStyle Libre 2 Discharge Trial
Diabetes Mellitus, Type 2, Hypoglycemia
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Hospital discharge, algorithm, CGM, technology, type 2 diabetes, hospital hyperglycemia
Eligibility Criteria
Inclusion Criteria: 1. Males and females ≥18 years of age admitted to general medicine and surgery services. 2. Known history of T2D treated with oral antidiabetic agents (sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinedione, DPP-4 inhibitors, SGLT2- inhibitors), GLP1-RAs (exenatide, liraglutide, dulaglutide, semaglutide) or insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs [ lispro, aspart, glulisine, fast acting insulin aspart, insulin lispro]), intermediate acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations. 3. Discharged on insulin therapy consisting of basal therapy 1) with or without bolus insulin and also 2) with or without other diabetes drugs. Exclusion Criteria: 1. Subjects admitted with a diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state. 2. Subjects using CGM technology prior to admission 3. Subjects with type 1 diabetes 4. Subjects not willing to receive insulin injections or test POC 4 times daily 5. Subjects discharged from the hospital on diabetes therapy that does not include basal insulin. 6. Subjects not willing to wear a CGM device 7. Pregnant women 8. Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), dialysis, critically ill or terminal illness. 9. Subjects with history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study. 10. Subjects expected to be readmitted to the hospital within 3 months post-discharge.
Sites / Locations
- Palo Alto Medical Foundation Research InstituteRecruiting
- Division of Endocrinology, Department of Medicine, Emory University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
FreeStyle Libre 2
Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing
Subjects randomized to Group 1: FreeStyle Libre 2 will wear two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. They will have two sensors inserted under their skin: FreeStyle Libre 2 sensor with display on, meaning they will be able to see their blood sugar values on the mobile application or a reader. FreeStyle Libre Pro sensor is used without mobile application or reader. This sensor is place as a backup in case the information is missing from the Libre 2 sensor.
Subjects randomized to Group 2: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing will wear one FreeStyle Libre Pro CGM sensor without using the mobile application or reader (blinded). These subjects will have the one sensor inserted under their skin but you will not see sugar values on the CGM. Subjects will wear the CGM for 12-14 days three times over a 12-week (3 month) period but will not use the CGM to monitor and control their blood sugar. Instead, they will monitor their sugar values by the standard method of fingerstick before each meal and at bedtime.