Diabetes MellitusNCT00277732
Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
A study testing Pharmaceutical care at baseline and follow-up visits over 6 months in people with Diabetes Mellitus, run by University Ghent at 1 site in Belgium.
Trial summary
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pharmaceutical care at baseline and follow-up visits over 6 months
- Type of treatment
- Surgery or procedure
- How many people
- 288 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2006to Nov 2006
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-75 years
- Body Mass Index >= 25
- Diabetes treatment for at least 12 months
- Regular visitors of the participating community pharmacy
Who cannot join
- Patients taking only insulin (no oral antidiabetic drugs)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).
- Conditions
- Diabetes Mellitus
- Being tested
- Pharmaceutical care at baseline and follow-up visits over 6 months
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care at baseline and follow-up visits over 6 monthsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the study groups in the change of blood glucose and HbA1c
Measured: baseline and after 6 months
Secondary outcomes (7)
Knowledge about diabetes and treatment
Measured: after 6 months
Therapy adherence
Body Mass Index
Measured: after 6 months
Periods of severe hypoglycemia
GP visits, emergency room visits and hospitalisations
Work days lost
Frequency of eye and foot examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJan 2006
- Study completionNov 2006
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.
- More trials run by University GhentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Mimi Giri, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277732
- Sponsor's protocol ID
- 2005/340
- Status last verified
- Dec 2007
- First submitted
- 13 Jan 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00277732
- Acronym / sponsor ID
- 2005/340
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Nov 2006
- First posted
- 16 Jan 2006 (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 objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45-75 years
- Body Mass Index >= 25
- Diabetes treatment for at least 12 months
- Regular visitors of the participating community pharmacy
Key exclusion criteria (1 listed)
- Patients taking only insulin (no oral antidiabetic drugs)
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 |
|---|---|---|
| Pharmaceutical care at baseline and follow-up visits over 6 months | Procedure or surgery | – |
Primary outcome
The difference between the study groups in the change of blood glucose and HbA1c
Time frame: baseline and after 6 months
7 secondary outcomes
Knowledge about diabetes and treatment
Time frame: after 6 months
Therapy adherence
Body Mass Index
Time frame: after 6 months
Periods of severe hypoglycemia
GP visits, emergency room visits and hospitalisations
Work days lost
Frequency of eye and foot examination
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 28 Dec 2007.
- Website University GhentLink provided by the sponsor.
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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.
Mimi Giri, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care at baseline and follow-up visits over 6 months in people with Diabetes Mellitus, run by University Ghent at 1 site in Belgium.
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 4 inclusion and 1 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 28 Dec 2007. 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 Belgium. 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.
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?
The difference between the study groups in the change of blood glucose and HbA1c (time frame: baseline and after 6 months). 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 28 Dec 2007.