Time in Glucose Hospital Target (TIGHT)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Continuous glucose monitoring, Hypoglycemia, Glycemia, Hyperglycemia, In-patient, Hospital
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 years old
Type 2 diabetes (per investigator assessment); or if not previously diagnosed as having diabetes, HbA1c>=7.0% (laboratory-measured at or since hospital admission or within prior 3-months).
• Type 1 diabetes, atypical forms of diabetes (including pancreatectomy and pancreatitis) and stress hyperglycemia alone are not eligible.
- At least 1 blood glucose measurement >180 mg/dL since admission
- Insulin already initiated since admission or planned to be initiated
- Non-critical hospitalization with expected length of stay on non-ICU floor >3 days at time of randomization
Exclusion Criteria:
- Inability to provide written consent
Admission to ICU
• Patients transferred from ICU with an expected length of stay >3 days on a non-ICU floor are eligible
- Treatment with systemic immunosuppressive agents such as high dose (>7.5 mg/day Prednisone equivalent) steroids or biologics at time of enrollment or planned treatment prior to randomization
- Suspected or confirmed acute myocardial infarction or stroke as reason for hospital admission or since admission
- Considered unlikely to survive hospitalization per investigator's judgment
- Diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the 6 months prior to hospital admission, at hospital admission or prior to randomization during the current hospital admission
- One or more severe hypoglycemic events within the 6 months prior to hospital admission or prior to randomization during the current admission
For females, pregnant or breastfeeding
• A negative serum or urine pregnancy test will be required for all females of child-bearing potential.
- CGM other than study CGM being used during hospitalization or planned to be used
- Blood glucose >400 mg/dL at time of potential enrollment (most recent blood glucose measurement in hospital)
- Insulin pump being used to deliver insulin during hospitalization or planned to be used
- Use of IV insulin at time of potential enrollment
- Hypoxia (O2 saturation <90) present at time of potential enrollment
- Anasarca present at time of potential enrollment
- Use of hydroxyurea or high dose acetaminophen use of >4g daily
- eGFR <20 mL/min or dialysis being received or planned
- ALT >3X normal or current diagnosis of cirrhosis
- Cystic fibrosis
Expected need for surgery requiring general anesthesia during hospitalization
• Post-surgical enrollment is permitted
- Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
Sites / Locations
- University of Colorado, Anschutz Inpatient Pavilion 1 and 2Recruiting
- Emory UniversityRecruiting
- Baltimore Research and Education Foundation
- University of North Carolina HospitalsRecruiting
- University of Pittsburgh Medical CenterRecruiting
- University of Washington Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Target Group
Intensive Target Group
Standard therapy with glucose target 140-180 mg/dL (ADA guidelines) and masked CGM
Intensive therapy with glucose target 90-130 mg/dL with real-time CGM