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

Type 2 Diabetes Clinical Trial

— Sainté Diabète  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440555
• Other study ID #: OBS2014-2
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: May 27, 2016
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1305
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (inclusion day)	No
Secondary	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	Day 1 (inclusion day)	No
Secondary	To evaluate the cost of the targeted screening and the screening accessibility to population from the priority health area of Saint-Etienne		Month 2	No
Secondary	To evaluate the numbers of patients screened by self-administered questionnaire and diagnosed as diabetics using fasting glucose.		Month 2	No