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

This study has been completed.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00645827
First received: March 25, 2008
Last updated: August 11, 2009
Last verified: March 2009
  Purpose

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 Intervention
Glucose, Blood
Other: IICE Dosing
Other: Healthcare Provider dosing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of an Insulin Infusion Conversion Equation (IICE) to Improve Inpatient Glycemic Control: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • % of serum blood glucose values within 80-140 mg/dL [ Time Frame: Within 24 hours after cessation of IV insulin ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hypoglycemia (serum blood glucose < 70 mg/dL) [ Time Frame: Within 24 hours after cessation of IV insulin ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: 2
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645827

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

No publications provided

Responsible Party: Gregory Randall (Randy) Smith, Jr. MD, Emory University School of Medicine
ClinicalTrials.gov Identifier: NCT00645827     History of Changes
Other Study ID Numbers: 00006564
Study First Received: March 25, 2008
Last Updated: August 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Insulin
Blood Glucose

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014