Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Sliding-Scale Insulin Therapy; Other: Physiologic Insulin Therapy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40391

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop-University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized patients with type 2 diabetes mellitus admitted to a medical or surgical service

Description

Inclusion Criteria:

• Type 2 diabetes

Exclusion Criteria:

• Pregnant
• Admitted directly to an intensive care unit
• Length of stay <2 days

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Historical control group (H); Winthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011	Other: Sliding-Scale Insulin Therapy
Intervention group (I); Winthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012	Other: Physiologic Insulin Therapy
Parallel control group (P-sub-H); Patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region	Other: Sliding-Scale Insulin Therapy
Parallel control group (I-sub-H); Patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region	Other: Sliding-Scale Insulin Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Winthrop University Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Donald A Brand, Ph.D., Winthrop University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 15, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 756440-2; R18DK104110 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No