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Trial record 32 of 7527 for:    Type 2 Diabetes

Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose (Sainté Diabète)

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ClinicalTrials.gov Identifier: NCT02440555
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 30, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

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.


Condition or disease Intervention/treatment
Type 2 Diabetes Other: fulfill the self-administered questionnaire

Study Design

Study Type : Observational
Actual Enrollment : 1305 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : November 2014
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
patients included
fulfill the self-administered questionnaire.
Other: fulfill the self-administered questionnaire
Patients viewed in a pharmacy or a hospital fulfill the self-administered questionnaire before having a capillary blood glucose measurement.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Specificity of detection of type 2 diabetes [ Time Frame: Day 1 (inclusion day) ]
    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

  2. 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 ]
  3. To evaluate the numbers of patients screened by self-administered questionnaire and diagnosed as diabetics using fasting glucose. [ Time Frame: Month 2 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Man or woman
  • 45 years or older
  • Signed informed consent

Exclusion Criteria:

  • fasting glucose performed in the last 2 years
  • diabetes history
  • not living in Saint-Etienne
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440555


Locations
France
Chu Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Sanofi
Investigators
Study Director: Christophe BOIS, Pr Université de Saint-Etienne
More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02440555     History of Changes
Other Study ID Numbers: OBS2014-2
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
diabetes, capillary blood glucose, self-administered questionnaire

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases