Improving Glycemic Control on GMS: A Quality Improvement Study

August 9, 2019 updated by: Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects will include all type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who do not have an indication for IV insulin.

Exclusion Criteria:

  • Type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who have an indication for IV insulin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
admission to medical team floor to usual care
Experimental: Intervention
consists of usual care as well as an admission order set built into BWH's proprietary computer provider order entry (CPOE) system
Behavioral: Order Set, Education, Feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Point-of-care testing glucose values (percent of routine glucose readings between 60 and 180 mg/dL)
- Lab glucose values (percent of routine glucose readings between 60 and 180 mg/dL)

Secondary Outcome Measures

Outcome Measure
- Quality of insulin orders using explicit criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 30, 2005

First Submitted That Met QC Criteria

December 30, 2005

First Posted (Estimate)

January 4, 2006

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-P-001880/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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