Efficacy of Structured Insulin Order

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Efficacy of Structured Insulin Orders in Improving Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130558
• Other study ID #: 2008P-0022131
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: May 24, 2010
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: May 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Diabetes Management
Using electronic insulin order template for basal-bolus insulin and education

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood Glucose		6 days	No
Secondary	rates of glucose values less than 60 mg/dl or less than 40 mg/dl		6 days	Yes
Secondary	rate of use of sliding scale insulin		6 days	No