An interventional study of DIABEMPIC in Type 2 Diabetes, sponsored by Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico · Not applicable, Interventional, and Prevention
Type 2 diabetes is one of the leading causes of morbidity and mortality rate in Mexico. Although important advances in treatment strategies have been developed in type 2 diabetes mellitus, large gaps exist in achieving quality of care. Few studies have determined the effect of multicomponent interventions in low and middle income countries. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.
Background: Diabetes mellitus is a chronic metabolic disease with disabling, deadly, and costly consequences for individuals, families, and national health care systems. Proper diabetes management in people living with type 2 diabetes mellitus focuses on reducing the risks for macrovascular and microvascular complications through controlling blood pressure, lipid levels, and blood glucose levels, and avoiding tobacco. Although important advances in pharmacological and non-pharmacological strategies have been developed, large gaps exist in achieving care goals, particularly in real-world practice and low- and middle- income countries. Barriers to care in T2DM patients may include lack of medical care, poverty, long distances or lack of time to get medical attention, lack of confidence, and inadequate social support, among others. Achievement of diabetes care goals: normal glycated hemoglobin, blood pressure, and LDL cholesterol is associated with better health outcomes, including lower risks of complicating events and death. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through a 6-months intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, , and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.
Hypothesis: Participation in the Diabetes Empowerment and Improvement of Care strategy allows reaching diabetes care goals.
General objective: To quantify diabetes care goals achievement at the end of the intervention and one year after finishing the comprehensive care program designed to propitiate diabetes empowerment at Clínica Especializada en el Manejo de la Diabetes of the Mexico City Government.
Specific objectives: To measure the program impact through the following variables: glycated hemoglobin, blood lipids, arterial pressure, self-care activities, diabetes knowledge, health related quality of life, incidence of complications and use of hospital services.
Goals: To improve diabetes care through this multicomponent intervention in order to prevent complications and and enhance quality of life in people with diabetes, but also to expand the care model to primary care health units in Mexico City.
Methodology: The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. Intervention consists of visits at Clínica Especializada en el Manejo de la Diabetes to attend individual and group sessions in a shared medical appointment model by an interdisciplinary case management team. The program last five months and visits occur every 2 weeks according to the needs assessed by the interdisciplinary team. Interdisciplinary team include: endocrinology, diabetes educator, nutritionist, podiatrist, ophthalmologist, psychologist, social worker and dentist. At each visit standardized interventions based in clinical practice guidelines are executed. At the initial, last visit and yearly visit preset indicators are evaluated, including: weight, blood pressure, glycated hemoglobin, lipid profile, creatinine, albumin/creatinin index in urine sample and validated questionaires related to diabetes self-care (Summary of Diabetes Self-care Activities) and Health related quality of life (EuroQOL-5Q-5L). The effect of the intervention will be determined on the improvement on metabolic parameters, as well as in self care activities and quality of life using a "before and after design". As a secondary analysis, results will be compared with the population in the wait-list receiving routine care in primary care units.
Expected results: In case of demonstrating its effectiveness, DIABEMPIC program is considered to be expanded in order to allow more people living with diabetes to receive the benefits of a Multicomponent intervention in Mexico City.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 800 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the wait-list being attended with the standard model of care for diabetes in primary care units.
Intervention comprised by an interdisciplinary team care, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication.
Behavioral: DIABEMPIC
Patients are attended by 9 diabetes health-care professionals every 2 weeks for 5 months in a shared medical appointment scheme, including individual and group sessions. Patients will be evaluated at the end of the program and 1 year after.
Glycemic control after the program
HbA1c (%): HbA1c will be compared from the first visit with the last visit (5 months later)
Time frame: 5 months
Glycemic control after 1 year
HbA1c (%): HbA1c will be compared from the the last visit with the visit 1 year apart
Time frame: 1 year
Lipid control
Total Cholesterol, HDL-Cholesterol and Non-HDL Cholesterol in mg/dL will be compared from the first visit with the last visit (5 months later).
Time frame: 5 months
Weight change
Weight Change (Kg) will be compared from the first visit with the last visit (5 months later).
Time frame: 5 months
Blood pressure
Systolic and diastolic blood pressure (mmHg) will be compared from the first visit with the last visit (5 months later).
Time frame: 5 months
Blood pressure
Systolic and diastolic blood pressure (mmHg) will be compared from the last visit with the visit 1 year apart.
Time frame: 1 year
Lipid control
Total Cholesterol, HDL-Cholesterol and Non-HDL Cholesterol in mg/dL will be compared from the last visit with the visit 1 year apart.
Time frame: 1 year
Weight change
Weight Change in kilograms will be compared from the last visit with the visit 1 year apart.
Time frame: 1 year
Summary of Self-care Activities (0-7, higher score means better self-care)
Summary of Self-care Activities Questionnaire (nutrition, exercise, glucose test, foot care) in days a week (0-7, higuer score means better self-care). Self-care will be compared from the first visit with the last visit (5 months later).
Time frame: 5 months
Summary of Self-care Activities (0-7, higher score means better self-care)
Summary of Self-care Activities Questionnaire (nutrition, exercise, glucose test, foot care) in days a week (0-7, higuer score means better self-care). Self-care will be compared from the last visit with the visit one year apart
Time frame: 1 year
Health-related Quality of Life perception assessed by EQ-5D Visual Analogue Scale questionnaire (0-100, higuer score means better Quality of life perception)
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the first visit with the last visit (5 months later).
Time frame: 5 months
Health-related Quality of Life perception assessed by EQ-5D Visual Analogue Scale questionnaire (0-100, higher score means better Quality of life perception)
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higuer score means better quality of life). Health-related Quality of Life will be compared from the last visit with the visit one year apart.
Time frame: 1 year
Health-related Quality of Life perception assessed by EQ-5D Indexed score (0-1, higher score means better Quality of life perception)
Health-related Quality of life perception with EQ-5D questionnaire indexed score (0-100, higuer score means better quality of life). Health-related Quality of Life will be compared from the first visit with the last visit (5 months later)
Time frame: 5 months
Health-related Quality of Life perception assessed by EQ-5D Indexed score (0-1, higher score means better Quality of life perception)
Health-related Quality of life perception with EQ-5D questionnaire indexed score (0-100, higuer score means better quality of life). Health-related Quality of Life will be compared from the last visit with visit one year apart
Time frame: 1 year
Glycemic control of the patients who attended the program compared with patients attended in primary care units (wait-list)
HbA1c (%). Comparison will be the mean deviation change of patients attending the program and patients with routine care in 5 months follow-up.
Time frame: 5 months
Lipid control of the patients who attended the program compared with patients attended in primary care units (wait-list)
Total Cholesterol, HDL-Cholesterol and Non-HDL Cholesterol in mg/dL . Comparison will be the mean deviation change of patients attending the program and patients with routine care in 5 months follow-up.
Time frame: 5 months
Weight change of the patients who attended the program compared with patients attended in primary care units (wait-list)
Weight change in kilograms. Comparison will be the mean deviation change of patients attending the program and patients with routine care in 5 months follow-up.
Time frame: 5 months
Blood pressure of the patients who attended the program compared with patients attended in primary care units (wait-list)
Systolic and diastolic blood pressure change in mmHg. Comparison will be the mean deviation changes of patients attending the program and patients with routine care in 5 months follow-up.
Time frame: 5 months
Plan to share: Yes — Data generated is not publicly available due that data used are from patients and are under policies for private confidential information, but will be available at the end of the study on reasonable request and using unidentifiable IDs. Results are planned to be shared through Journal publication.
Supporting information: Study protocol, Sap, Icf, Csr
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