Text Size

Efficacy of Structured Insulin Order

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01130558
First received: May 24, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Structured Insulin Orders in Improving Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Mean blood Glucose [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rates of glucose values less than 60 mg/dl or less than 40 mg/dl [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • rate of use of sliding scale insulin [ Time Frame: 6 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Enrico Cagliero, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01130558     History of Changes
Other Study ID Numbers: 2008P-0022131
Study First Received: May 24, 2010
Last Updated: May 24, 2010
Health Authority: United States: Institutional Review Board

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013