Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868606
• Other study ID #: 756440-2
• Secondary ID: R18DK104110
• Status: Completed
• Start date: July 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2019
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40391
• Est. completion date: June 30, 2018
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes

Exclusion Criteria:

• Pregnant

• Admitted directly to an intensive care unit

• Length of stay <2 days

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia

Intervention

Other:
• Physiologic Insulin Therapy

• Sliding-Scale Insulin Therapy

Locations

Country	Name	City	State
United States	Winthrop-University Hospital	Mineola	New York

Sponsors (2)

Lead Sponsor	Collaborator
Winthrop University Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfer to intensive care unit (y/n)	Assigned "y" if patient is transferred to an intensive care unit for any length of time; otherwise, assigned "n".	Upon hospital discharge (median length of stay, 5 days)
Secondary	Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)		Upon hospital discharge (median length of stay, 5 days)
Secondary	Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)		Upon hospital discharge (median length of stay, 5 days)
Secondary	Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)		Upon hospital discharge (median length of stay, 5 days)
Secondary	Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)		Upon hospital discharge (median length of stay, 5 days)
Secondary	Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)		Upon hospital discharge (median length of stay, 5 days)
Secondary	Development of any complication (y/n)		Upon hospital discharge (median length of stay, 5 days)
Secondary	In-hospital death (y/n)		Upon hospital discharge (median length of stay, 5 days)