We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Structured Insulin Order

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130558
First Posted: May 26, 2010
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Massachusetts General Hospital
  Purpose
The purpose of this study is to determine whether an electronic order template for basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients with poorly controlled type 2 diabetes.

Condition Intervention
Type 2 Diabetes Mellitus Other: Diabetes Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Structured Insulin Orders in Improving Glycemic Control

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Mean blood Glucose [ Time Frame: 6 days ]

Secondary Outcome Measures:
  • rates of glucose values less than 60 mg/dl or less than 40 mg/dl [ Time Frame: 6 days ]
  • rate of use of sliding scale insulin [ Time Frame: 6 days ]

Enrollment: 128
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ordering template and education
Internal medical residents who were asked to use the insulin order template and received education about basal-bolus insulin ordering.
Other: Diabetes Management
Using electronic insulin order template for basal-bolus insulin and education
Active Comparator: Education
Internal medical residents who received education about basal-bolus insulin ordering.
Other: Diabetes Management
Using electronic insulin order template for basal-bolus insulin and education

Detailed Description:
The study randomly assigned internal medicine residents to use an electronic insulin order template plus basal-bolus ordering education versus education only. For all patients with uncontrolled type 2 diabetes treated by these physicians, mean blood glucose, rate of hypoglycemia, and rate of sliding scale insulin use were measured.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Blood glucose less than 60 mg/dl or greater than 180 mg/dl during hospital stay

Exclusion Criteria:

  • Diagnosis of Type 1 Diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130558


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Enrico Cagliero, M.D. Massachusetts General Hospital
  More Information

Responsible Party: Enrico Cagliero, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01130558     History of Changes
Other Study ID Numbers: 2008P-0022131
First Submitted: May 24, 2010
First Posted: May 26, 2010
Last Update Posted: May 26, 2010
Last Verified: May 2010

Keywords provided by Massachusetts General Hospital:
type 2 diabetes mellitus
basal-bolus insulin
insulin ordering

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs