NCT01130558

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable type-2-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

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
Last Updated

May 26, 2010

Status Verified

May 1, 2010

Enrollment Period

3 months

First QC Date

May 24, 2010

Last Update Submit

May 24, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitusbasal-bolus insulininsulin ordering

Outcome Measures

Primary Outcomes (1)

  • Mean blood Glucose

    6 days

Secondary Outcomes (2)

  • rates of glucose values less than 60 mg/dl or less than 40 mg/dl

    6 days

  • rate of use of sliding scale insulin

    6 days

Study Arms (2)

Ordering template and education

ACTIVE COMPARATOR

Internal medical residents who were asked to use the insulin order template and received education about basal-bolus insulin ordering.

Other: Diabetes Management

Education

ACTIVE COMPARATOR

Internal medical residents who received education about basal-bolus insulin ordering.

Other: Diabetes Management

Interventions

Diabetes ManagementOTHER

Using electronic insulin order template for basal-bolus insulin and education

EducationOrdering template and education

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Diagnosis of Type 1 Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Enrico Cagliero, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 26, 2010

Record last verified: 2010-05

Locations

US(1)