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

NCT03283774 | Completed DMC

• 1 other identifier: GOL-DML-2015-01
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Outcome Measures

Primary Outcomes (13)

• Diagnosis of the most common cardiovascular risk factors

  High Blood Pressure (more then \>140/90mm Hg), Dyslipidaemia, Smoking and Obesity

  2007-2013

• Level of of glycated haemoglobin (HbA1c)

  The value closer and prior to the DTALL date will be considered. A window of up to a year before the DTALL date will be accepted (i.e., from July 1 of the previous year up to DTALL)

  2007-2013

• Average of the three last measurements of systolic and diastolic blood pressure

  A window of up to a year before the DTALL date will be accepted (i.e., from July 1 of the previous year up to DTALL). If there are no 3 BP measurements, the average of 2 measurements or the value closer and prior to DTALL will be accepted

  2007-2013

• Levels of Total Cholesterol (TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C), triglycerides (TGC) and non-HDL Cholesterol.

  A window of up to a year before the DTALL date will be accepted (i.e., from July 1 of the previous year up to DTALL)

  2007-2013

• Body Mass Index (BMI)

  A window of up to a year before the DTALL date will be accepted (i.e., from July 1 of the previous year up to DTALL). BMI values and calculation of BMI with weight in kg and height in m will be accepted. The height value accepted will be that closer to DTALL measured after 18 years of age. Priority will be given to the calculation with weight in kg and height in m over a BMI value. The date of the calculation of the BMI with the weight and height will determine the weight value

  2007-2013

• Kidney function: glomerular filtration estimated by MDRD

  The value closer and prior to the DTALL date will be considered. A window of up to a year before the DTALL date will be accepted (i.e., from July 1 of the previous year up to DTALL)

  2007-2013

• Kidney function: urinary albumin excretion (albumin/creatinine ratio).

  The value closer and prior to the DTALL date will be considered. A window of up to a year before the DTALL date will be accepted (i.e., from July 1 of the previous year up to DTALL)

  2007-2013

• Use of hypoglycaemic agents (oral and/or GLP1) and insulin on the DTALL date

  Monotherapy and combined therapy with other hypoglycaemic agents will be analysed. Dosage will not be specified. Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut).

  2007-2013

• Use of antihypertensive, hypolipidemic, antiplatelet and anticoagulant agents on the DTALL date

  Monotherapy and therapy combined with hypoglycaemic agents will be analysed. Dosage will not be specified. Data of use will be obtained from the pharmacy billing of the Catalan Health Service (CatSalut)

  2007-2013

• Cardiovascular disease

  Ischemic heart disese Cerebrovascular accident with codes Arterial peripheral disease with codes Heart failure with codes Cardiovascular procedures such as coronary revascularization, revascularization and non-traumatic lower extremity amputation

  2007-2013

• Diagnosis of Diabetic retinopathy

  Diabetic retinopathy on the DTALL date

  2007-2013

• Causes of mortality in the population with type 2 diabetes during the study period

  Causes of mortality in the population with type 2 diabetes during the study period

  2007-2013

• Cost analysis

  Pharmacological treatment, which will include pharmacological treatment of diabetes complications. * Number of visits carried out by primary care professionals (physician, nurse and other) * Visits carried out by specialists. * Number of referrals. * Medical tests. * Sick leave days * Hospital admissions (number of days in hospital and cost) * Number of test strips used for self-monitoring.

  2007-2013

Interventions

current clinical practice OTHER

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

Eligibility Criteria

• Age: 31 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is selected from 5,8 million people from the 282 primary care centres of the Catalan Health Service identified with an anonymized personal identifier and included in a unique patient registry called "SIDIAP" for primary care in Catalonia (North East region in Spain)

You may qualify if:

• Female and male patients \> 30 years of age with a clinical record in the SIDIAP database.
• Patients with a diagnosis of type 2 diabetes (codes ICD10: E11, E11.0-E11.9, E14, E14.0-E14.9) on June 30 (DTALL) of each year.

You may not qualify if:

• Patients with a diagnosis of type 1 diabetes (E10), gestational diabetes (O24), secondary diabetes (E12) or any other type of diabetes (E13)

Sponsors & Collaborators

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

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Josep Franch

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: September 14, 2017
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

ES (1)