Diabetes MellitusSEGUDIABNCT01087541
SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients
A study testing Educational program 6-hour standardized in people with Diabetes Mellitus, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays. 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?
- Educational program 6-hour standardized
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,830 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of diabetes
- Aged between 45 and 75 years
Who cannot join
- No data in informatic system
- Severe illness
- Controlled only by specialists
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Health Care. Catalan Health Institute. Tarragona-Reus
Reus, Tarragona, 43202
About this study
Official title: SEGUDIAB Study: Safety in Diabetic Patients. Evaluation of an Educational Program for the Professionals to Improve the Safety in Diabetic Patients
The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays.
OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is followed of an improvement in the safety of the diabetic patients.
Read more
METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA) with a random distribution of the educative intervention to realize on the sanitary professionals (5 intervention/5 control). The intervention is an educative system on adults, brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the diabetics. The group control follows his usual clinical practice on the diabetics.
The participation was voluntary. The centres have been matched, being comparable in population and other characteristics, except the specific intervention; ranging between the 6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected only between 45 until 75 years old as operative age group of the 45 until the 75 years like operative aim.
Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the informatic software for primary care.
Exclusion criteria: serious or terminal illness or patients controlled exclusively by specialists.
- Conditions
- Diabetes Mellitus
- Being tested
- Educational program 6-hour standardized
- Keywords
- Patient's Safety, Diabetes mellitus, Public Health for professionals, Safety, Public health
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program 6-hour standardizedBehavioural
Also called Standardized educational programs, Patients safety
6-hour standardized program for adults ( doctors and nurses )
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual clinical health care |
| Intervention | Experimental | Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses ) Receives: Behavioral: Educational program 6-hour standardized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Haemoglobin A1c at Start
Measured: Baseline
Glycosylated Haemoglobin A1c at 6 Months
Glycohemoglobin A1c at 6 months.
Measured: 6 months
Secondary outcomes (4)
BMI ( Body Mass Index ) at Start
Measured: Baseline
BMI at 6 Months
Measured: 6 months
Blood Pressure ( Systolic / Diastolic )
Measured: Baseline
Systolic and Diastolic Blood Pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Fundación Avedis Donabedian
- Investigators
- Juan J Cabré, MD, PhD, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087541
- Sponsor's protocol ID
- SEGUDIAB
- Acronym
- SEGUDIAB
- Status last verified
- Mar 2011
- First submitted
- 15 Mar 2010
- Last updated
- 29 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cabre JJ, Ripoll M, Hernandez JM, Basora J, Bejarano F, Arija V. Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. BMC Public Health. 2011 Jun 5;11:430. doi: 10.1186/1471-2458-11-430.
PubMed 21639938
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEGUDIAB Study: Safety in Diabetic Patients. Evaluation of an Educational Program for the Professionals to Improve the Safety in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01087541
- Acronym / sponsor ID
- SEGUDIAB / SEGUDIAB
- Conditions
- Diabetes Mellitus
- Keywords
- Patient's Safety, Diabetes mellitus, Public Health for professionals, Safety, Public health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,830 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Fundación Avedis Donabedian
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Posted 24 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays.
OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is followed of an improvement in the safety of the diabetic patients.
METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA) with a random distribution of the educative intervention to realize on the sanitary professionals (5 intervention/5 control). The intervention is an educative system on adults, brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the diabetics. The group control follows his usual clinical practice on the diabetics.
The participation was voluntary. The centres have been matched, being comparable in population and other characteristics, except the specific intervention; ranging between the 6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected only between 45 until 75 years old as operative age group of the 45 until the 75 years like operative aim.
Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the informatic software for primary care.
Exclusion criteria: serious or terminal illness or patients controlled exclusively by specialists.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual clinical health care |
| Intervention | Experimental | Behavioral: Educational program 6-hour standardizedBehavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses ) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of diabetes
- Aged between 45 and 75 years
Key exclusion criteria (3 listed)
- No data in informatic system
- Severe illness
- Controlled only by specialists
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 |
|---|---|---|
| Educational program 6-hour standardizedAlso: Standardized educational programs, Patients safety6-hour standardized program for adults ( doctors and nurses ) | Behavioural | Intervention |
Primary outcome
Glycosylated Haemoglobin A1c at Start
Time frame: Baseline
Glycosylated Haemoglobin A1c at 6 Months
Time frame: 6 months
Glycohemoglobin A1c at 6 months.
4 secondary outcomes
BMI ( Body Mass Index ) at Start
Time frame: Baseline
BMI at 6 Months
Time frame: 6 months
Blood Pressure ( Systolic / Diastolic )
Time frame: Baseline
Systolic and Diastolic Blood Pressure
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21639938Cabre JJ, Ripoll M, Hernandez JM, Basora J, Bejarano F, Arija V. Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. BMC Public Health. 2011 Jun 5;11:430. doi: 10.1186/1471-2458-11-430.
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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.
Juan J Cabré, MD, PhD principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program 6-hour standardized in people with Diabetes Mellitus, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 29 Mar 2011. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycosylated Haemoglobin A1c at Start (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT01087541, 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 29 Mar 2011.