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

NCT02440555 | Completed

• 1 other identifier: OBS2014-2
• Study Type: observational
• Target: 1,305
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes, capillary blood glucose, self-administered questionnaire

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Specificity of detection of type 2 diabetes

  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

  Month 2

• To evaluate the numbers of patients screened by self-administered questionnaire and diagnosed as diabetics using fasting glucose.

  Month 2

Study Arms (1)

patients included

fulfill the self-administered questionnaire.

Other: fulfill the self-administered questionnaire

Interventions

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.

patients included

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Sanofi: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christophe BOIS, Pr

  Université de Saint-Etienne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

FR (1)