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OpenTrials
Completed

NCT Number: NCT02440555

Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fulfill the self-administered questionnaire

Other

Patients viewed in a pharmacy or a hospital fulfill the self-administered questionnaire before having a capillary blood glucose measurement.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Sanofi

Registry information

Official study 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.

Acronym: Sainté Diabète

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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