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

• ClinicalTrials.gov Identifier: NCT00645827
• Recruitment Status: Completed
• First Posted: March 28, 2008
• Results First Posted: September 15, 2014
• Last Update Posted: September 15, 2014
• Sponsor: Emory University
• Information provided by (Responsible Party): G. Randy Smith, Jr., M.D., Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glucose, Blood	Other: IICE Dosing; Other: Healthcare Provider dosing	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of an Insulin Infusion Conversion Equation (IICE) to Improve Inpatient Glycemic Control: A Randomized Controlled Trial
• Study Start Date: January 2008
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
Active Comparator: Control; Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.	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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Blood Glucose Values Within 80-140 mg/dL [ Time Frame: Within 24 hours after cessation of IV insulin ]
   Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL

Secondary Outcome Measures :

1. Hypoglycemia (Serum Blood Glucose < 70 mg/dL) [ Time Frame: Within 24 hours after cessation of IV insulin ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Georgia

Emory Crawford Long Hospital

Atlanta, Georgia, United States, 30308

Sponsors and Collaborators

Emory University

Investigators

• Principal Investigator: Gregory R Smith, Jr., MD; Emory University

More Information

• Responsible Party: G. Randy Smith, Jr., M.D., Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT00645827
• Other Study ID Numbers: IRB00006564
• First Posted: March 28, 2008
• Results First Posted: September 15, 2014
• Last Update Posted: September 15, 2014
• Last Verified: September 2014

Keywords provided by G. Randy Smith, Jr., M.D., Emory University:

Insulin; Blood Glucose