Clinical trial NCT00645827: Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients
Official title: Use of an Insulin Infusion Conversion Equation (IICE) to Improve Inpatient Glycemic Control: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, Blood
Keywords: Insulin
Blood Glucose
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and they are effective. However, insulin infusions require the use of limited resources. Insulin infusions are therefore changed to insulin shots as a patient recovers. Once an insulin infusion is stopped and shots are started, blood sugar control is harder to maintain. This is, in part, because physicians have different ideas on how to dose insulin shots in hospitalized patients. A math equation has been developed by the research staff that attempts to predict the effective doses of insulin shots in patients whose insulin infusion have just been stopped. The math equation was developed for patients with type 2 diabetes mellitus. In this study, all patients will be treated with the same type of insulin shots, with doses of the insulin shots chosen either by the math equation or by the judgment of the patient's physician. The study will then follow blood sugar values for 24 hours to see if the math equation is effective. If the equation is proven to be effective, a new tool will exist for physicians to determine the best dose of insulin shots for type 2 diabetics. Such a tool would, in turn, allow for widespread use of insulin infusions to determine a patient's insulin needs before discharge from the hospital. Blood sugar control for type 2 diabetics that are inpatient or outpatient would improve as a result, with potentially far reaching public health benefits.


Eligibility criteria: Inclusion Criteria:

* Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled.
* Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU).

Exclusion Criteria:

* At time of enrollment, patients with type I diabetes mellitus,
* active acute or chronic pancreatitis,
* history of pancreatic surgery,
* use of a self-titratable insulin pump, or
* history of β-islet cell transplantation were excluded.
* At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of \> 20% in previous 24 hours, or
* those without caloric intake while on IV insulin were excluded.

Primary outcomes:
measure: Percentage of Blood Glucose Values Within 80-140 mg/dL
timeFrame: Within 24 hours after cessation of IV insulin
Secondary outcomes:
measure: Hypoglycemia (Serum Blood Glucose < 70 mg/dL)
timeFrame: Within 24 hours after cessation of IV insulin
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Gregory R Smith, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: