Diabetes Mellitus Type 2NCT01154413
Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical
A study testing Intensive education of the doctor/nursing team on the protocol in people with Diabetes Mellitus Type 2, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial summary
To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Intensive education of the doctor/nursing team on the protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to May 2009
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years
Who cannot join
- Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study
About this study
Official title: Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical Trial
To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.
Read the detailed description
Management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days.
Eligibility criteria:
Patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, aged greater 18 years.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Intensive education of the doctor/nursing team on the protocol
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive education of the doctor/nursing team on the protocolBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intensive education of the doctor/nursing team on the protocol | Experimental | Not described Receives: Behavioral: Intensive education of the doctor/nursing team on the protocol |
| Without intervention in the team | No intervention | Not described Receives: Behavioral: Intensive education of the doctor/nursing team on the protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in hypo/hyperglycemia episodes
Secondary outcomes (1)
Lower mean glycemia, reduced time of stay in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154413
- Sponsor's protocol ID
- UP3984/07
- Status last verified
- Jun 2010
- First submitted
- 29 Jun 2010
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Moraes MA, Rodrigues J, Cremonesi M, Polanczyk C, Schaan BD. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial. Clinics (Sao Paulo). 2013 Nov;68(11):1400-7. doi: 10.6061/clinics/2013(11)03.
PubMed 24270950
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01154413
- Acronym / sponsor ID
- UP3984/07
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Jun 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.
To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.
Detailed description
Management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days.
Eligibility criteria:
Patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, aged greater 18 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive education of the doctor/nursing team on the protocol | Experimental | Behavioral: Intensive education of the doctor/nursing team on the protocol |
| Without intervention in the team | No intervention | Behavioral: Intensive education of the doctor/nursing team on the protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years
Key exclusion criteria (1 listed)
- Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study
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 |
|---|---|---|
| Intensive education of the doctor/nursing team on the protocol | Behavioural | Intensive education of the doctor/nursing team on the protocol, Without intervention in the team |
Primary outcome
Reduction in hypo/hyperglycemia episodes
1 secondary outcome
Lower mean glycemia, reduced time of stay in hospital
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 30 Jun 2010.
- Derived from this study: PubMed 24270950Moraes MA, Rodrigues J, Cremonesi M, Polanczyk C, Schaan BD. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial. Clinics (Sao Paulo). 2013 Nov;68(11):1400-7. doi: 10.6061/clinics/2013(11)03.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive education of the doctor/nursing team on the protocol in people with Diabetes Mellitus Type 2, run by Instituto de Cardiologia do Rio Grande do Sul.
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 1 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 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction in hypo/hyperglycemia episodes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154413, which also lists 1 linked publication.
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 30 Jun 2010.