Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, hyperglycemia
Treatments physiologic insulin therapy, sliding-scale insulin therapy
Sponsor Winthrop University Hospital
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date July 2015
End date September 2016
Trial size 41400 participants
Trial identifier NCT02868606, 756440-2, R18DK104110

Summary

Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home. Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated these benefits except in patients who are critically ill. The purpose of this study, therefore, is to evaluate whether such insulin therapy actually does reduce in-hospital complications, deaths, need for intensive care, or length of stay in the hospital.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Winthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011
sliding-scale insulin therapy
Winthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012
physiologic insulin therapy
Patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region
sliding-scale insulin therapy
Patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region
sliding-scale insulin therapy

Primary Outcomes

Measure
Transfer to intensive care unit (y/n)
time frame: Upon hospital discharge (median length of stay, 5 days)

Secondary Outcomes

Measure
Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)
time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)
time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)
time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)
time frame: Upon hospital discharge (median length of stay, 5 days)
Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)
time frame: Upon hospital discharge (median length of stay, 5 days)
Development of any complication (y/n)
time frame: Upon hospital discharge (median length of stay, 5 days)
In-hospital death (y/n)
time frame: Upon hospital discharge (median length of stay, 5 days)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Type 2 diabetes Exclusion Criteria: - Pregnant - Admitted directly to an intensive care unit - Length of stay <2 days

Additional Information

Official title Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
Principal investigator Donald A Brand, Ph.D.
Description The primary aim of the proposed study is to determine if physiologic insulin therapy administered to general hospital inpatients with hyperglycemia favorably affects in-hospital complications and mortality, need for intensive care, or length of stay. The secondary aim is to determine if the magnitude of benefit derived from this therapy differs (a) in patients with known vs. newly diagnosed diabetes, or (b) in medical vs. surgical patients. The study will analyze data from a natural experiment that occurred when the applicant institution introduced universal physiologic insulin therapy as the standard of care for hyperglycemia. A quasi-experimental before-and-after study will compare in-hospital complications, mortality, and resource use in patients with comorbid type 2 diabetes before vs. after implementation of this standard (n≈6400). Outcomes measured at 7 nearby acute-care teaching hospitals during the same two time intervals will provide parallel control data (n≈35,000). Data from the control hospitals will make it possible to evaluate whether temporal changes in patient characteristics or other variables affecting hospitals in the region could explain effects that might otherwise be erroneously attributed to the intervention. Given the high prevalence of comorbid diabetes in the hospital and the possibility that universal physiologic insulin for managing hyperglycemia may not deliver the intended benefit or could even do more harm than good, answering this question is an important goal.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Winthrop University Hospital.