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Multifactorial Control of Type 2 Diabetes and Treatment Intensity in Primary Care

NCT03283774 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300000

Last updated 2017-09-15

No results posted yet for this study

Summary

Main Objective: To identify changes in metabolic control of type 2 diabetes in patients of the Catalan national health system during 2007-2013.

Study design: Follow-up of a population with type 2 diabetes during 7 years (2007-2013).

Study participants: Approximately 300,000 people with a clinical record in the SIDIAP database.

Source: SIDIAP database. Variables and measurements: Age, gender, time since diagnosis of type 2 diabetes, associated cardiovascular risk factors, micro- and macrovascular complications of diabetes, causes of mortality, treatment for hyperglycaemia and for modifiable risk factors, other conditions related to diabetes and its management. The economic costs of diabetes during the study period will also be analyzed.

Analysis: The clinical variables will be described and 95% confidence intervals will be calculated for the main variables associated with the study outcomes. Missing values will count as non-existing data and missing value imputation will not be used in the analysis. If a subgroup of patients is considered of particular interest, sub analyses will be carried out. Predictive variables of good metabolic control and of complications and mortality of diabetes will be analyzed with the hazard ratios for each factor.

Results:

Applicability: The results related to control of diabetes will serve as a basis for improving metabolic control and decreasing chronic complications and to optimize cost-effectiveness of treatments.

Significance: A long-term study of a population receiving usual treatment is required to understand the changes in indicators of metabolic control, morbidity and mortality and in the management of the disease.

Limitations: Those associated with the use of large population databases.

Conditions

Interventions

OTHER

current clinical practice

quality management (data registration, drug prescription, diagnostic and clinical tests ...), in primary care of patients with diabetes mellitus

Sponsors & Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Josep Franch · IDIAP JORDI GOL

Eligibility

Min Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-04-30
Completion
2017-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283774 on ClinicalTrials.gov