NCT02663245.

Trial name or title	INTEGRA Study: Primary care Intervention in Type 2 diabetes patients with poor glycaemic control
Methods	NRCT
Participants	Inclusion criteria Diagnosis of Type 2 DM according to criteria of the World Health Organization of one or more years of disease duration Age from 30 to 80 years HbA1C ≥ 9% (DCCT) according to the last blood test carried out during the 12 months prior to inclusion in the study No changes in the treatment that can influence the main variable during the 3 months prior inclusion in the study Accepting to participate in the study and signing of the informed consent form Exclusion criteria Patient refuses to participate and any other condition that prevents signing the informed consent form Other types of diabetes: Type 1 DM, gestational diabetes and diabetes secondary to other diseases Pharmacological treatments that interfere with carbohydrate metabolism, such as steroids Life expectancy under 2 years Current treatment for cancer other than basocellular or epidermoid skin cancer Severe mental disease and dementia Heart failure Class III or IV (NYHA). Renal transplant or current treatment with dialysis Alcohol and drug abuse Pregnancy or intention to get pregnant Breastfeeding Chronic treatment with steroids; treatment with steroids during the 2 months prior inclusion in the study Pharmacological treatment for weight loss during the 2 months prior to inclusion in the ‐ study Treatment with immunosuppressants Haemoglobinopathies and chronic anemia Body Mass Index > 45 mg/kg2 (1) Participation in clinical trials for medicines. Patients with conditions that prevent follow up and completion of protocol.
Interventions	Experimental: intervention 1 Diabetes specific consultation + multicomponent intervention aimed at professionals and patients Experimental: intervention 2 Multicomponent intervention aimed at professionals and patients minus the diabetes specific consultation. No Intervention: control group No intervention. Data of the control groups will be retrieved from the SIDIAP.
Outcomes	Primary outcome Glycaemic control measured by HbA1c Secondary outcomes Lipid profile control as measured by the mean concentration of LDL‐cholesterol, non‐HDL cholesterol and triglycerides Measurement of systolic blood pressure and of diastolic blood pressure Control of chronic complications associated with type 2 diabetes according to the protocol of the CIH Patient self‐efficacy to implement changes in risk factors: Morisky‐Green questionnaire Direct health costs of type 2 diabetic patients Evaluation of patient satisfaction using Spanish version of diabetes treatment satisfaction questionnaire (DTSQ) Control of risk factors, smoking and exercise: Patient Activation Measure questionnaire Evaluation of therapeutic inertia: specific questionnaire created by Redgedaps Evaluation of quality of life using Spanish version of diabetes quality of life questionnaire (EsDQOL)
Starting date	December 2015
Contact information	Esther Rubinat, PhD, RN, 646186720, rubinatesther@gmail.com
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