Type 2 DiabetesPhase 3ROSESNCT01176149
Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin
A Phase 3 study testing SMBG plus intensive education in people with Type 2 Diabetes, run by Consorzio Mario Negri Sud at 1 site in Italy.
Trial summary
The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SMBG plus intensive education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Apr 2010
- Phase
- Phase 3
- 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
- Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
- Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or TZDs alone);
- No need for insulin treatment;
- Male and female patients, aged between 45-75 years;
- Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
- No experience of self monitoring of blood glucose in the previous 12 months (SMBG performed with a frequency of < 1 times/week)
- Ability and willingness to comply with all study requirements
- Signature of consent form
Who cannot join
- Patients incapable to perform SMBG
- Patients needing insulin or multiple OHA association therapy
- Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
- Diabetes care not exclusively managed by diabetic clinics
- Patients with serious underlying medical or psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study
The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.
- Conditions
- Type 2 Diabetes
- Being tested
- SMBG plus intensive education
- Keywords
- Diabetes, Self monitoring blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMBG plus intensive educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SMBG + intensive education | Experimental | Patients will receive specific educational interventions to teach them how to perform Self monitoring Blood Glucose (SMBG), how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals (weight reduction, reduction in fat consumption intake, reduction in saturated fat intake, increase in fiber intake, regular physical activity. Receives: Behavioral: SMBG plus intensive education |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of metabolic control
Aim of this study is to evaluate the efficacy of Self Monitoring Blood Glucose and Intensive Education in terms of improvement of metabolic control expressed as HbA1c levels after 6 months.
Secondary outcomes (3)
Reduction in prandial Blood Glucose excursions
Percentage of patients needing therapy modifications
Percentage of patients reaching target HbA1c (i.e. <7.0%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startMar 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Mario Negri Sud
- Sponsor type
- University, hospital or other
- Collaborators
- LifeScan
- Investigators
- Antonio Nicolucci, MD, Study director, Consorzio Mario Negri Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176149
- Sponsor's protocol ID
- ROSES-01
- Acronym
- ROSES
- Status last verified
- Aug 2010
- First submitted
- 4 Aug 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study
- ClinicalTrials.gov ID
- NCT01176149
- Acronym / sponsor ID
- ROSES / ROSES-01
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Self monitoring blood glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Consorzio Mario Negri SudUniversity, hospital or other
- Collaborators
- LifeScan
- Study start
- Mar 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Aug 2010 (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 aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMBG + intensive education | Experimental | Behavioral: SMBG plus intensive educationPatients will receive specific educational interventions to teach them how to perform Self monitoring Blood Glucose (SMBG), how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals (weight reduction, reduction in fat consumption intake, reduction in saturated fat intake, increase in fiber intake, regular physical activity. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
- Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or TZDs alone);
- No need for insulin treatment;
- Male and female patients, aged between 45-75 years;
- Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
Key exclusion criteria (5 listed)
- Patients incapable to perform SMBG
- Patients needing insulin or multiple OHA association therapy
- Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
- Diabetes care not exclusively managed by diabetic clinics
- Patients with serious underlying medical or psychiatric condition
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 |
|---|---|---|
| SMBG plus intensive education | Behavioural | SMBG + intensive education |
Primary outcome
Improvement of metabolic control
Aim of this study is to evaluate the efficacy of Self Monitoring Blood Glucose and Intensive Education in terms of improvement of metabolic control expressed as HbA1c levels after 6 months.
3 secondary outcomes
Reduction in prandial Blood Glucose excursions
Percentage of patients needing therapy modifications
Percentage of patients reaching target HbA1c (i.e. <7.0%)
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 6 Aug 2010.
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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.
Antonio Nicolucci, MD study director
Consorzio Mario Negri Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMBG plus intensive education in people with Type 2 Diabetes, run by Consorzio Mario Negri Sud at 1 site in Italy.
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 8 inclusion and 5 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 6 Aug 2010. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improvement of metabolic control. 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 6 Aug 2010.