Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients

NCT ID: NCT00645827

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Glucose, Blood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin infusion conversion equation

Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.

Group Type: EXPERIMENTAL

IICE Dosing

Intervention Type: OTHER

Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.

Control

Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.

Group Type: ACTIVE_COMPARATOR

Healthcare Provider dosing

Intervention Type: OTHER

Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.

Interventions

IICE Dosing

Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.

Intervention Type: OTHER

Healthcare Provider dosing

Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \[3 x scheduled aspart dose\]). For BG \< 70 mg/dL, ½ ampule D50W IV x1 was given.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

G. Randy Smith, Jr., M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory R Smith, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00006564

Identifier Type: -

Identifier Source: org_study_id