Time in Glucose Hospital Target

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT05135676

Run by

Jaeb Center for Health Research

People needed

169

Starts

2022-05-10

Expected to finish

2024-03-01

Last updated by the study team

2024-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 that are not regimented and have been started within the last 3 months 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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