Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/3/2017 |
| Start Date: | July 2015 |
| End Date: | June 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- Type 2 diabetes
Exclusion Criteria:
- Pregnant
- Admitted directly to an intensive care unit
- Length of stay <2 days
We found this trial at
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site
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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