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Time in Glucose Hospital Target
Sponsor: Jaeb Center for Health Research
Summary
Inpatient management of glycemia in people with diabetes has been inadequately studied. Previous randomized trials of intensive insulin therapy in the hospital setting resulted in excessive hypoglycemia. Current ADA guidelines (glucose 140-180 mg/dL) are by consensus with the upper bound defined by observational data and the lower bound by safety concerns. None of the previous studies of intensive glucose management used CGM technology. Whether near normal glucose levels can be achieved without increasing hypoglycemia among hospitalized patients with diabetes with the advent of CGM technology is not known. There are clear associations between hyperglycemia and poor outcomes in patients with diabetes hospitalized with infection, including COVID-19. The COVID-19 pandemic has increased the urgency to definitively answer the question of whether glucose lowering below 140-180 mg/dL can be achieved without increasing hypoglycemia. If this proposed study demonstrates intensive management of glucose to a target of 90 to 130 mg/dL without hypoglycemia is achievable in the inpatient setting with CGM technology, a larger study could then be performed to evaluate whether there is clinical benefit including a reduction in morbidity and mortality. The primary study hypothesis is that glucose management with CGM can achieve a mean glucose of 90-130 mg/dL without increasing hypoglycemia compared with standard care with a glucose target of 140-180 mg/dL. Individuals with diabetes who are hospitalized (non-ICU) for an eligible condition will be randomly assigned to receive standard therapy (glucose target 140-180 mg/dL per ADA guidelines) or intensive therapy (glucose target 90-130 mg/dL and CGM used for monitoring). Real-time CGM will be used in the Intensive Target Group and masked CGM will be used in the Standard Target Group. The co-primary outcomes, assessed via a hierarchical approach, include a treatment group comparison of mean glucose (superiority) followed by a non-inferiority comparison of time \<54 mg/dL measured with CGM.
Official title: Time in Glucose Hospital Target (TIGHT) - A Randomized Clinical Trial to Evaluate the Use of CGM to Achieve a Mean Glucose Target of 90 to 130 mg/dL Without Hypoglycemia in Hospitalized Adults With Type 2 Diabetes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
166
Start Date
2022-05-10
Completion Date
2024-03-01
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Blinded CGM
A masked CGM sensor will be worn
real-time CGM
An unmasked CGM sensor will worn
Locations (6)
University of Colorado, Anschutz Inpatient Pavilion 1 and 2
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Baltimore Research and Education Foundation
Baltimore, Maryland, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Washington Medical Center
Seattle, Washington, United States