Barriers to the Implementation of Complete Insulin Order Sets - Full Text View

Sponsors and Collaborators:	Park Nicollet Institute International Diabetes Center Park Nicollet Foundation
Information provided by:	Park Nicollet Institute
ClinicalTrials.gov Identifier:	NCT00813280

Purpose

The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG >300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the BG >300 mg/dl).

Condition
Hyperglycemia

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Barriers to the Implementation of Complete Insulin Order Sets in the Management of Individuals With Hyperglycemia or Diabetes at Park Nicollet Methodist Hospital

Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:

glucose levels [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

type of insulin treatment [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	200
Study Start Date:	June 2008
Study Completion Date:	December 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
hyperglycemia hospitalized patients with BG >300 ml/dL

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

hospitalized patients with blood glucose >300 mg/dL

Criteria

Inclusion Criteria:

Park Nicollet Methodist Hospital patient
recorded BG > 300 mg/dL during the study data collection period
admitted to general floor hospital units

Exclusion Criteria:

birth center
intensive care units
eating disorder unit
pediatric patients < 18 years of age
patients receiving insulin infusions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813280

Locations

United States, Minnesota
Park Nicollet Methodist Hospital
Minneapolis, Minnesota, United States, 55416

Sponsors and Collaborators

Park Nicollet Institute

International Diabetes Center

Park Nicollet Foundation

Investigators

Principal Investigator:	Lisa Fish, MD	Park Nicollet Health Services Endocrinology
Principal Investigator:	Robert M Cuddihy, MD	International Diabetes Center

More Information

Publications:

van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65.

Responsible Party:	( Lisa Fish, MD )
Study ID Numbers:	03735-08-A
Study First Received:	December 19, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813280
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus

Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 13, 2009