Type 2 DiabetesSainté DiabèteNCT02440555
Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose
An observational study of Type 2 Diabetes, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Type 2 diabetes is the chronic disease with the most important development in France, and particularly in the Saint-Etienne area due to his specific population. Different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- fulfill the self-administered questionnaire
- How many people
- 1,305 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Mar 2015
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population is composed by patients living in the Saint-Etienne area, 45 years or older, not known as diabetics, and viewed in a pharmacy or a hospital.
Who may be able to join
- Man or woman
- 45 years or older
- Signed informed consent
Who cannot join
- fasting glucose performed in the last 2 years
- diabetes history
- not living in Saint-Etienne
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose Compared to Current Screening in the Priority Health Area of Saint-Etienne and the Sainté Diabète Network.
Type 2 diabetes is the chronic disease with the most important development in France, and particularly in the Saint-Etienne area due to his specific population.
Different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality.
Read more
The current screening recommandation is an opportunist targeted screening on population older than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire screening targeted on population older than 45 years suffering precarity with or without risk factors by capillary blood glucose or fasting glucose.
The objective of the Sainté Diabete network is to optimize the screening of diabetics, their follow-up and their treatments. Using a self-administered questionnaire during a medical visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.
- Conditions
- Type 2 Diabetes
- Being tested
- fulfill the self-administered questionnaire
- Keywords
- diabetes, capillary blood glucose, self-administered questionnaire
- 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.
fulfill the self-administered questionnaireOther
Patients viewed in a pharmacy or a hospital fulfill the self-administered questionnaire before having a capillary blood glucose measurement.
| Study group | Role | What they receive |
|---|---|---|
| patients included | fulfill the self-administered questionnaire. Receives: Other: fulfill the self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of detection of type 2 diabetes
To evaluate the sensitivity (true positive) of detection of type 2 diabetes by a self-administered questionnaire performed in a pharmacy or a hospital compared to capillary blood glucose measurements in the same population from the priority health area of Saint-Etienne.
Measured: Day 1 (inclusion day)
Secondary outcomes (3)
Specificity of detection of type 2 diabetes
To evaluate the specificity (true negative) of detection of type 2 diabetes by a self-administered questionnaire performed in a pharmacy or a hospital compared to capillary blood glucose measurements in the same population from the priority health area of Saint-Etienne
Measured: Day 1 (inclusion day)
To evaluate the cost of the targeted screening and the screening accessibility to population from the priority health area of Saint-Etienne
Measured: Month 2
To evaluate the numbers of patients screened by self-administered questionnaire and diagnosed as diabetics using fasting glucose.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
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.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,305 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Christophe BOIS, Pr, Study director, Université de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440555
- Sponsor's protocol ID
- OBS2014-2
- Acronym
- Sainté Diabète
- Status last verified
- May 2016
- First submitted
- 7 May 2015
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose Compared to Current Screening in the Priority Health Area of Saint-Etienne and the Sainté Diabète Network.
- ClinicalTrials.gov ID
- NCT02440555
- Acronym / sponsor ID
- Sainté Diabète / OBS2014-2
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, capillary blood glucose, self-administered questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,305 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 May 2015 (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.
Type 2 diabetes is the chronic disease with the most important development in France, and particularly in the Saint-Etienne area due to his specific population.
Different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality.
The current screening recommandation is an opportunist targeted screening on population older than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire screening targeted on population older than 45 years suffering precarity with or without risk factors by capillary blood glucose or fasting glucose.
The objective of the Sainté Diabete network is to optimize the screening of diabetics, their follow-up and their treatments. Using a self-administered questionnaire during a medical visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients included | – | Other: fulfill the self-administered questionnairefulfill the self-administered questionnaire. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population is composed by patients living in the Saint-Etienne area, 45 years or older, not known as diabetics, and viewed in a pharmacy or a hospital.
Key inclusion criteria (3 listed)
- Man or woman
- 45 years or older
- Signed informed consent
Key exclusion criteria (3 listed)
- fasting glucose performed in the last 2 years
- diabetes history
- not living in Saint-Etienne
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 |
|---|---|---|
| fulfill the self-administered questionnairePatients viewed in a pharmacy or a hospital fulfill the self-administered questionnaire before having a capillary blood glucose measurement. | Other | patients included |
Primary outcome
Sensitivity of detection of type 2 diabetes
Time frame: Day 1 (inclusion day)
To evaluate the sensitivity (true positive) of detection of type 2 diabetes by a self-administered questionnaire performed in a pharmacy or a hospital compared to capillary blood glucose measurements in the same population from the priority health area of Saint-Etienne.
3 secondary outcomes
Specificity of detection of type 2 diabetes
Time frame: Day 1 (inclusion day)
To evaluate the cost of the targeted screening and the screening accessibility to population from the priority health area of Saint-Etienne
Time frame: Month 2
To evaluate the numbers of patients screened by self-administered questionnaire and diagnosed as diabetics using fasting glucose.
Time frame: Month 2
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 May 2016.
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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.
Christophe BOIS, Pr study director
Université de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 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 30 May 2016. 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 France. 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?
Sensitivity of detection of type 2 diabetes (time frame: Day 1 (inclusion day)). 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 30 May 2016.