Diabetes MellitusPhase 4NCT00869076
Pharmacists Management of Diabetes
A Phase 4 study testing Pharmacist Management in people with Diabetes Mellitus, run by Advantage Health Physician Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pharmacist Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- A1c greater than or equal to 9.0
Who cannot join
- Not expected to live for the duration of the study
- Managed by an endocrinologist
- Unwillingness to participate and attend pharmacist visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Advantage Health Physican Network
Grand Rapids, Michigan, 49503
About this study
Official title: Pharmacist Management of Diabetes Mellitus: A Randomized Controlled Trial.
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Pharmacist Management, Usual care
- Keywords
- Diabetes Mellitus, Pharmacist
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist ManagementOther
Pharmacist Managed the patient's diabetes in collaboration with their primary care physician
Usual careOther
Patient was managed by their primary care physician as usual
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Management | Experimental | In this arm the Pharmacist managed the Diabetes in collaboration with the primary care physician Receives: Other: Pharmacist Management |
| Usual Care | Active comparator | The patient was managed by the primary care physician Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hgb A1c change
Measured: 1 year
Secondary outcomes (3)
HgbA1c change based on ethnicity
Measured: one year
percent of patients with a 1 point or greater decrease in A1c
Measured: one year
Percent of patients with a 1 point decrease in A1c by ethnicity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advantage Health Physician Network
- Sponsor type
- University, hospital or other
- Collaborators
- Doran Foundation, Michigan Pharmacist Foundation, Priority Health, Western Michigan Society of Health System Pharmacists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869076
- Sponsor's protocol ID
- PharmacistDiabetesJameson
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2009
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Management of Diabetes Mellitus: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00869076
- Acronym / sponsor ID
- PharmacistDiabetesJameson
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Pharmacist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Advantage Health Physician NetworkUniversity, hospital or other
- Collaborators
- Doran Foundation, Michigan Pharmacist Foundation, Priority Health, Western Michigan Society of Health System Pharmacists
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Management | Experimental | Other: Pharmacist ManagementIn this arm the Pharmacist managed the Diabetes in collaboration with the primary care physician |
| Usual Care | Active comparator | Other: Usual careThe patient was managed by the primary care physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- A1c greater than or equal to 9.0
Key exclusion criteria (3 listed)
- Not expected to live for the duration of the study
- Managed by an endocrinologist
- Unwillingness to participate and attend pharmacist visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist ManagementPharmacist Managed the patient's diabetes in collaboration with their primary care physician | Other | Pharmacist Management |
| Usual carePatient was managed by their primary care physician as usual | Other | Usual Care |
Primary outcome
Hgb A1c change
Time frame: 1 year
3 secondary outcomes
HgbA1c change based on ethnicity
Time frame: one year
percent of patients with a 1 point or greater decrease in A1c
Time frame: one year
Percent of patients with a 1 point decrease in A1c by ethnicity
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacist Management in people with Diabetes Mellitus, run by Advantage Health Physician Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hgb A1c change (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.