NCT00869076

Brief Summary

The hypothesis is that patients with poorly controlled diabetes would have greater improvement in their blood sugar control when managed by a clinical pharmacist than when managed with usual medical care. Patients with poor control are randomized to pharmacist management or to usual medical care for one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

March 23, 2009

Last Update Submit

March 24, 2009

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusPharmacist

Outcome Measures

Primary Outcomes (1)

  • Hgb A1c change

    1 year

Secondary Outcomes (3)

  • HgbA1c change based on ethnicity

    one year

  • percent of patients with a 1 point or greater decrease in A1c

    one year

  • Percent of patients with a 1 point decrease in A1c by ethnicity

    one year

Study Arms (2)

Pharmacist Management

EXPERIMENTAL

In this arm the Pharmacist managed the Diabetes in collaboration with the primary care physician

Other: Pharmacist Management

Usual Care

ACTIVE COMPARATOR

The patient was managed by the primary care physician

Other: Usual care

Interventions

Pharmacist ManagementOTHER

Pharmacist Managed the patient's diabetes in collaboration with their primary care physician

Pharmacist Management
Usual careOTHER

Patient was managed by their primary care physician as usual

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • A1c greater than or equal to 9.0

You may not qualify if:

  • Not expected to live for the duration of the study
  • Managed by an endocrinologist
  • Unwillingness to participate and attend pharmacist visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advantage Health Physican Network

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 25, 2009

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

US(1)