NCT00271700

Brief Summary

This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
4.3 years until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

December 30, 2005

Last Update Submit

August 9, 2019

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusOutcome Assessment (Healthcare)InpatientsHospital Information SystemsEducation

Outcome Measures

Primary Outcomes (2)

  • - 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 Outcomes (1)

  • - Quality of insulin orders using explicit criteria

Study Arms (2)

Usual Care

NO INTERVENTION

admission to medical team floor to usual care

Intervention

EXPERIMENTAL

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

Interventions

Order Set, Education, FeedbackBEHAVIORAL
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jeffrey L Schnipper, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jeffrey Schnipper, MD

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 4, 2006

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

US(1)