Management of Hyperglycemia in the ER: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care (NOVO ER)
In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis and many patients with uncontrolled diabetes are admitted to the hospital after initial evaluation in the ED. Currently there are no guidelines in the US for the management of hyperglycemia in patients with diabetes during the duration of evaluation and treatment in the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. In this study, we hypothesize that a defined two-step approach to the management of high blood sugars with insulin injections initiated in the ED may decrease length of stay in the ED or hospital, improve clinical outcome and prevent some hospital complications. In the first phase, patients with diabetes admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive scheduled aspart or the usual care as dictated by the ED physicians. In the second phase, patients enrolled in the first phase that are subsequently admitted to the hospital will receive a combination of detemir and aspart insulin or usual care as dictated by the Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120 patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo Nordisk.
|Diabetes||Drug: aspart insulin Drug: Usual care as prescribed by the ED physicians.||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care|
- to determine whether initiation of hyperglycemia management in the ED with scheduled aspart insulin for patients versus usual care with type 2 diabetes will result in a decrease in subsequent hospital length of stay. [ Time Frame: once all subjects have been recruited ]
- to determine diff. in the mean BG during the ED stay, the mean BG achieved during hospital, frequency of hypoglycemia during the ED and hospital visits among those treated with the scheduled protocol insulin regimen vs. usual hyperglycemia mgmt [ Time Frame: once all subjects have been recruited ]
Subcutaneous aspart insulin every 2 hours
Drug: aspart insulin
subcutaneous aspart insulin every 2 hours
Placebo Comparator: Active Comparator
Usual care as prescribed by the ED physicians
Drug: Usual care as prescribed by the ED physicians.
Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663624
|Principal Investigator:||Dawn Smiley, MD||Emory SOM|