Type 2 DiabetesCAIPADINCT02836808
Validation of an Integrated Attention Model for Patients With Type 2 Diabetes
A study testing CAIPaDi in people with Type 2 Diabetes, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Abstract: Empowerment interventions for chronic diseases are an evolving process. No agreement exists regarding the necessary components and methodologies to be applied. Systematic reviews have assessed the effect of self-management interventions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CAIPaDi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteMexico
- Study dates
- 31 Oct 2013to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over 18 and under 70 years old
- having diagnosis of type 2 diabetes in the five previous years,
- having family support
- free of disabling diabetes complications
Who cannot join
- advanced complications of diabetes, such as ischemic heart disease, heart failure NYHA III-IV, KDOQI ≥3 renal failure, amputations, cerebral vascular disease, gastroparesis and muscular atrophy .
- type 1 diabetes mellitus, gestational diabetes or some variant of diabetes related to genetic syndromes, hyperlabile diabetes
- co-morbidities that limit their life expectancy such as malignant tumors
- advanced cognitive impairment or serious psychiatric disorders
- smoking, alcoholism or illegal drug dependence
- conditions that require surgical treatment in the short run or which prevent moderated activity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion
Mexico City, Mexico City, 14000
Carlos A Aguilar-Salinas, MD, 52-55-56554523, caguilarsalinas@yahoo.com
Sergio Hernández, MD
About this study
Abstract: Empowerment interventions for chronic diseases are an evolving process. No agreement exists regarding the necessary components and methodologies to be applied. Systematic reviews have assessed the effect of self-management interventions. Improvements in illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the long term, no major changes have been achieved in weight, physical activity, smoking status, and depression scores.
There is a need for additional studies. The Center for Comprehensive Care of Patients with Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment techniques (using simple low-cost interactive tools) over a short period of time followed by at-distance support using internet or cell phone technology. The target population consists of patients with type 2 diabetes, free of chronic complications who are non-smokers. The intervention is composed of four monthly visits followed by a continuous at-distance support system. At each visit, patients stay for six hours in the center. Information is presented in group sessions. Empowerment techniques are applied during individual exchanges with the team or during facilitated group sessions. In summary, empowerment programs are an unmet need in many healthcare services.
Read the detailed description
- Background: There are major deficiencies in the attention quality provided to people with diabetes in Mexico. The percentage of compliance of therapeutic objectives is noticeably lower than the one informed in developed countries. It is required to have structured management strategies, adapted to traits of our population, which allow improving attention quality in the medium term. The National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) developed an integrated management program by using the best evidence available. The target population is people with type 2 diabetes, with less than 5 years with the diagnosis, and is free from chronic complications. Selection criteria allow the intervention benefit to diminish incidence of chronic complications.
- Hypothesis: "The management strategy applied at the Center of Comprehensive Care for the Patient with Diabetes (CAIPaDi) allows achieving the international treatment standards (proposed by NCQA) in a two-year period".
- General and Specific objectives: General objective: To quantify the results one year after starting the integrated management program oriented to self-care activities applied at CAIPaDi. Specific objectives:
- To measure the program impact (after 4 months, one and two years) based on the following variables: self-care (measured with standardized questionnaires), efficacy parameters (HbA1c, fasting glycemia, blood lipids, arterial pressure and use of anti-platelet aggregates), execution parameters (compliance of evaluations and preventive measures such as the search for microalbuminuria, ophthalmologic check, influenza vaccination, among others), incidence of micro- and macrovascular complications of diabetes, hospitalizations, use of emergency service or unforeseen expenses related to diabetes.
- To compare the efficacy and execution parameters of the cases attended at the center, with patients with similar characteristics attended at the "Internal Medicine" service of the INCMNSZ.
- To carry out a study of the social-economic impact of the intervention.
- Goals: It is intended to validate an intervention that provides integrated attention to people with diabetes, in order to generate in the patient and his/her family, the competencies required for self-care in the long term and the prevention of chronic characteristics. Intervention is low-cost. This characteristic, along with the intervention systematization will allow the model to be exportable to the first-contact units.
- Scientific Methodology: CAIPaDi has the mission of improving quality of life of patients with diabetes by means of an intervention adapted to the needs of patients, applying step-by-step action programs". Intervention consists of four monthly visits, each one being 6 hours long. The visits have individual and group sessions. The nine specialists in the multidisciplinary team are endocrinologists, diabetes educator, nutritionists, psychologist, dentists, psychiatrist, specialist in physical activity, ophthalmologist and foot care. Some of the functions may be fulfilled by the same health professional, previously trained. At each session, standardized actions are applied, which are assessed with preset indicators. At the initial and at yearly visits the following laboratory tests are taken: glycated hemoglobin, blood chemistry, lipid profile, liver function tests, albumin-creatinine index in an isolated urine sample, and 12-deviation electrocardiogram. At the yearly visits the patients receive reinforcement and treatment modifications as needed. Contact is kept with patients via phone calls, e-mails and messages on the mobile phone. Patients are asked to send their assessments on preset dates. Materials and tools are developed, which allow measuring information from the study in real time, empowerment of patients and decision-making by the multi-disciplinary team, based on clinical practice guidelines. There will be information from 1200 patients with 2-year follow-up. Besides having information from 1200 additional cases with follow-up at one year, and other 1200 others with assessments at 6 months. Therefore, the population for assessing execution variables shall be of 3600 participants. Such sample size allows us to detect differences higher than 5% in the percentage of cases that comply with the therapeutic objectives by comparing them with the initial assessment. As a secondary analysis, results will be compared with the population that receives attention the "Internal Medicine" service in the INCMNSZ (n=300 subjects). Patients will be referred from clinics or first contact physicians outside the Institute.
- Expected impacts at medium and long term: This proposal allows validating the intervention designed and applied at CAIPaDi. In case of demonstrating its usefulness and cost-effectiveness, intervention will be exported to first-contact units. Manuals and tools have been developed which will allow the implementation of the program with minimum resources. Such action will allow creating a network of health units that operate with the same quality standards as INCMNSZ.
- Infrastructure available at the participating institutions: The INCMNSZ has an area where the center operates.
- Deliverable results: Procedure manuals for each of the actions included in the intervention, tools for decision making based on clinical practice guidelines which will be patented, educational materials designed for empowering patients (patentable products), an internet portal, an electronic file, a database, articles in high impact magazines, diploma courses for generating specific competencies related to diabetes treatment and to the center management.
- Conditions
- Type 2 Diabetes
- Being tested
- CAIPaDi
- Keywords
- Multidisciplinary interventions, Long term control, Empowerment
- Medical subject headings
- Diabetes Mellitus, Type 2, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIPaDiBehavioural
Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, dentists, psychiatrist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients attended with the standard model of care for diabetes, as out-patients in the Internal Medicine area |
| CAIPaDi | Experimental | Patients attended in the Center of Comprehensive Care for the Patient with Diabetes, where they receive attention from 9 specialists in 1 day Receives: Behavioral: CAIPaDi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes
HbA1c is measured in percentage (%). HbA1c will be compared from the first visit with the fourth visit.
Measured: 3 months
Secondary outcomes (17)
Diabetes control after 1 year in a structured multidisciplinary program for patients with diabetes
HbA1c is measured in percentage (%). HbA1c will be compared from the fourth visit with the visit 1 year apart.
Measured: 1 year
Metabolic parameters are lipid profile after 1 year in a structured multidisciplinary program for patients with diabetes
Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. All of them will be compared from the fourth visit with the visit 1 year apart.
Measured: 1 year
Renal function after 1 year in a structured multidisciplinary program for patients with diabetes
Renal function in mg/g (albumin/creatinine ratio). Renal function will be compared from the fourth visit with the visit 1 year apart.
Measured: 1 year
Self-care by SDSCA questionnaire after 1 year in a structured multidisciplinary program for patients with diabetes
Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. This will be compared from the fourth visit with the visit 1 year apart.
Measured: 1 year
Diabetic complications are eye, renal and foot evaluations after 1 year in a structured multidisciplinary program for patients with diabetes
Diabetic complications are eye, renal and foot evaluations. All of them will be compared from the fourth visit with the visit 1 year apart.
Measured: 1 year
Quality of life after 1 year in a structured multidisciplinary program for patients with diabetes
Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. This will be compared from the fourth visit with the visit 1 year apart.
Measured: 1 year
Diabetes control after 2 years in a structured multidisciplinary program for patients with diabetes
HbA1c is measured in percentage (%). HbA1c to be compared will be from fourth visit, 1 and 2 years apart.
Measured: 2 years
Metabolic parameters are lipid profile after 2 years in a structured multidisciplinary program for patients with diabetes
Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. The parameters to be compared will be from fourth visit, 1 and 2 years apart.
Measured: 2 years
Renal function after 2 years in a structured multidisciplinary program for patients with diabetes
Renal function in mg/g (albumin/creatinine ratio). The parameters to be compared will be from fourth visit, 1 and 2 years apart.
Measured: 2 years
Self-care by SDSCA questionnaire after 2 years in a structured multidisciplinary program for patients with diabetes
Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. The parameters to be compared will be from fourth visit, 1 and 2 years apart.
Measured: 2 years
Diabetic complications are eye, renal and foot after 2 years in a structured multidisciplinary program for patients with diabetes
Diabetic complications are eye, renal and foot evaluations. All of them will be compared from the fourth visit with the visit 1 year apart. The parameters to be compared will be from fourth visit, 1 and 2 years apart.
Measured: 2 years
Quality of life after 2 years in a structured multidisciplinary program for patients with diabetes
Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. The parameters to be compared will be from fourth visit, 1 and 2 years apart.
Measured: 2 years
Metabolic parameters are lipid profile after 4 visits in a structured multidisciplinary program for patients with diabetes
Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. All of them will be compared from the first visit with the fourth visit.
Measured: 3 months
Renal function after 4 visits in a structured multidisciplinary program for patients with diabetes
Renal function in mg/g (albumin/creatinine ratio). Renal function will be compared from the first visit with the fourth visit.
Measured: 3 months
Self-care by SDSCA questionnaire after 4 visits in a structured multidisciplinary program for patients with diabetes
Self-care evaluation will be determined by SDSCA questionnaire and an objective.
Measured: 3 months
Diabetic complications are eye, renal and foot evaluations after 4 visits in a structured multidisciplinary program for patients with diabetes
Diabetic complications are eye, renal and foot evaluations. All of them will be compared from the first visit with the fourth visit.
Measured: 3 months
Quality of life after 4 visits in a structured multidisciplinary program for patients with diabetes
Quality of life will be assessed with the DQoL (Diabetes Quality of Life) questionnaire. This will be compared from the first visit with the fourth visit.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start31 Oct 2013
- Primary completion9 Feb 2018
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio C Hernández, MD, Principal investigator, National Institute of Medical Sciences and Nutrition Salvador Zubirán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836808
- Sponsor's protocol ID
- dia-1190
- Acronym
- CAIPADI
- Status last verified
- Jul 2016
- First submitted
- 8 Apr 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Journal publication. The information to be shared will be metabolic parameters and questionaire results. The data will be available on 2016. Metabolic parameters will be obtained from blood samples and the questionnaires results from those self-applied or applied during praxis.
Publications
Villalpando S, Shamah-Levy T, Rojas R, Aguilar-Salinas CA. Trends for type 2 diabetes and other cardiovascular risk factors in Mexico from 1993-2006. Salud Publica Mex. 2010;52 Suppl 1:S72-9. doi: 10.1590/s0036-36342010000700011.
PubMed 20585732Aguilar Salinas CA, Gómez Diaz RA, Gomez Perez FJ. Diabetes en Mexico: Principales retos y posibles soluciones. Revista ALAD 2011: 19:146-161
Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012 Jun 16;379(9833):2252-61. doi: 10.1016/S0140-6736(12)60480-2. Epub 2012 Jun 9.
PubMed 22683130Planas LG, Crosby KM, Farmer KC, Harrison DL. Evaluation of a diabetes management program using selected HEDIS measures. J Am Pharm Assoc (2003). 2012;52(6):e130-8. doi: 10.1331/JAPhA.2012.11148.
PubMed 23224336Hernandez-Jimenez S, Garcia-Ulloa C, Mehta R, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D. Innovative models for the empowerment of patients with type 2 diabetes: the CAIPaDi program. Recent Pat Endocr Metab Immune Drug Discov. 2014;8(3):202-9. doi: 10.2174/1872214808999141110155515.
PubMed 25381833Landa-Anell MV, Del Razo-Olvera FM, Bodnar I, Cordova-Isidro B, Lagunas-Valdepena D, Arias-Marroquin AT, Garcia-Ulloa AC, Melgarejo-Hernandez MA, Hernandez-Jimenez S; Group of Study CAIPaDi. Nutritional diagnoses in people with type 2 diabetes: association with metabolic, anthropometric, and dietary parameters. Front Nutr. 2024 Oct 18;11:1473429. doi: 10.3389/fnut.2024.1473429. eCollection 2024.
PubMed 39494309Garcia-Ulloa AC, Almeda-Valdes P, Cuatecontzi-Xochitiotzi TE, Ramirez-Garcia JA, Diaz-Pineda M, Garnica-Carrillo F, Gonzalez-Duarte A, Narayan KMV, Aguilar-Salinas CA, Hernandez-Jimenez S; CAIPaDi Study Group. Detection of sudomotor alterations evaluated by Sudoscan in patients with recently diagnosed type 2 diabetes. BMJ Open Diabetes Res Care. 2022 Dec;10(6):e003005. doi: 10.1136/bmjdrc-2022-003005.
PubMed 36521878Garcia-Ulloa AC, Lechuga-Fonseca C, Del Razo-Olvera FM, Aguilar-Salinas CA, Galaviz KI, Narayan KMV, Hernandez-Jimenez S; Group of Study CAIPaDi. Clinician prescription of lipid-lowering drugs and achievement of treatment goals in patients with newly diagnosed type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e001891. doi: 10.1136/bmjdrc-2020-001891.
PubMed 33568360
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Integrated Attention Model for Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02836808
- Acronym / sponsor ID
- CAIPADI / dia-1190
- Conditions
- Type 2 Diabetes
- Keywords
- Multidisciplinary interventions, Long term control, Empowerment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 31 Oct 2013 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abstract: Empowerment interventions for chronic diseases are an evolving process. No agreement exists regarding the necessary components and methodologies to be applied. Systematic reviews have assessed the effect of self-management interventions. Improvements in illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the long term, no major changes have been achieved in weight, physical activity, smoking status, and depression scores.
There is a need for additional studies. The Center for Comprehensive Care of Patients with Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment techniques (using simple low-cost interactive tools) over a short period of time followed by at-distance support using internet or cell phone technology. The target population consists of patients with type 2 diabetes, free of chronic complications who are non-smokers. The intervention is composed of four monthly visits followed by a continuous at-distance support system. At each visit, patients stay for six hours in the center. Information is presented in group sessions. Empowerment techniques are applied during individual exchanges with the team or during facilitated group sessions. In summary, empowerment programs are an unmet need in many healthcare services.
Detailed description
- Background: There are major deficiencies in the attention quality provided to people with diabetes in Mexico. The percentage of compliance of therapeutic objectives is noticeably lower than the one informed in developed countries. It is required to have structured management strategies, adapted to traits of our population, which allow improving attention quality in the medium term. The National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) developed an integrated management program by using the best evidence available. The target population is people with type 2 diabetes, with less than 5 years with the diagnosis, and is free from chronic complications. Selection criteria allow the intervention benefit to diminish incidence of chronic complications.
- Hypothesis: "The management strategy applied at the Center of Comprehensive Care for the Patient with Diabetes (CAIPaDi) allows achieving the international treatment standards (proposed by NCQA) in a two-year period".
- General and Specific objectives: General objective: To quantify the results one year after starting the integrated management program oriented to self-care activities applied at CAIPaDi. Specific objectives:
- To measure the program impact (after 4 months, one and two years) based on the following variables: self-care (measured with standardized questionnaires), efficacy parameters (HbA1c, fasting glycemia, blood lipids, arterial pressure and use of anti-platelet aggregates), execution parameters (compliance of evaluations and preventive measures such as the search for microalbuminuria, ophthalmologic check, influenza vaccination, among others), incidence of micro- and macrovascular complications of diabetes, hospitalizations, use of emergency service or unforeseen expenses related to diabetes.
- To compare the efficacy and execution parameters of the cases attended at the center, with patients with similar characteristics attended at the "Internal Medicine" service of the INCMNSZ.
- To carry out a study of the social-economic impact of the intervention.
- Goals: It is intended to validate an intervention that provides integrated attention to people with diabetes, in order to generate in the patient and his/her family, the competencies required for self-care in the long term and the prevention of chronic characteristics. Intervention is low-cost. This characteristic, along with the intervention systematization will allow the model to be exportable to the first-contact units.
- Scientific Methodology: CAIPaDi has the mission of improving quality of life of patients with diabetes by means of an intervention adapted to the needs of patients, applying step-by-step action programs". Intervention consists of four monthly visits, each one being 6 hours long. The visits have individual and group sessions. The nine specialists in the multidisciplinary team are endocrinologists, diabetes educator, nutritionists, psychologist, dentists, psychiatrist, specialist in physical activity, ophthalmologist and foot care. Some of the functions may be fulfilled by the same health professional, previously trained. At each session, standardized actions are applied, which are assessed with preset indicators. At the initial and at yearly visits the following laboratory tests are taken: glycated hemoglobin, blood chemistry, lipid profile, liver function tests, albumin-creatinine index in an isolated urine sample, and 12-deviation electrocardiogram. At the yearly visits the patients receive reinforcement and treatment modifications as needed. Contact is kept with patients via phone calls, e-mails and messages on the mobile phone. Patients are asked to send their assessments on preset dates. Materials and tools are developed, which allow measuring information from the study in real time, empowerment of patients and decision-making by the multi-disciplinary team, based on clinical practice guidelines. There will be information from 1200 patients with 2-year follow-up. Besides having information from 1200 additional cases with follow-up at one year, and other 1200 others with assessments at 6 months. Therefore, the population for assessing execution variables shall be of 3600 participants. Such sample size allows us to detect differences higher than 5% in the percentage of cases that comply with the therapeutic objectives by comparing them with the initial assessment. As a secondary analysis, results will be compared with the population that receives attention the "Internal Medicine" service in the INCMNSZ (n=300 subjects). Patients will be referred from clinics or first contact physicians outside the Institute.
- Expected impacts at medium and long term: This proposal allows validating the intervention designed and applied at CAIPaDi. In case of demonstrating its usefulness and cost-effectiveness, intervention will be exported to first-contact units. Manuals and tools have been developed which will allow the implementation of the program with minimum resources. Such action will allow creating a network of health units that operate with the same quality standards as INCMNSZ.
- Infrastructure available at the participating institutions: The INCMNSZ has an area where the center operates.
- Deliverable results: Procedure manuals for each of the actions included in the intervention, tools for decision making based on clinical practice guidelines which will be patented, educational materials designed for empowering patients (patentable products), an internet portal, an electronic file, a database, articles in high impact magazines, diploma courses for generating specific competencies related to diabetes treatment and to the center management.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients attended with the standard model of care for diabetes, as out-patients in the Internal Medicine area |
| CAIPaDi | Experimental | Behavioral: CAIPaDiPatients attended in the Center of Comprehensive Care for the Patient with Diabetes, where they receive attention from 9 specialists in 1 day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being over 18 and under 70 years old
- having diagnosis of type 2 diabetes in the five previous years,
- having family support
- free of disabling diabetes complications
Key exclusion criteria (6 listed)
- advanced complications of diabetes, such as ischemic heart disease, heart failure NYHA III-IV, KDOQI ≥3 renal failure, amputations, cerebral vascular disease, gastroparesis and muscular atrophy .
- type 1 diabetes mellitus, gestational diabetes or some variant of diabetes related to genetic syndromes, hyperlabile diabetes
- co-morbidities that limit their life expectancy such as malignant tumors
- advanced cognitive impairment or serious psychiatric disorders
- smoking, alcoholism or illegal drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAIPaDiPatients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, dentists, psychiatrist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement. | Behavioural | CAIPaDi |
Primary outcome
Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes
Time frame: 3 months
HbA1c is measured in percentage (%). HbA1c will be compared from the first visit with the fourth visit.
17 secondary outcomes
Diabetes control after 1 year in a structured multidisciplinary program for patients with diabetes
Time frame: 1 year
Metabolic parameters are lipid profile after 1 year in a structured multidisciplinary program for patients with diabetes
Time frame: 1 year
Renal function after 1 year in a structured multidisciplinary program for patients with diabetes
Time frame: 1 year
Self-care by SDSCA questionnaire after 1 year in a structured multidisciplinary program for patients with diabetes
Time frame: 1 year
Diabetic complications are eye, renal and foot evaluations after 1 year in a structured multidisciplinary program for patients with diabetes
Time frame: 1 year
Quality of life after 1 year in a structured multidisciplinary program for patients with diabetes
Time frame: 1 year
Diabetes control after 2 years in a structured multidisciplinary program for patients with diabetes
Time frame: 2 years
Metabolic parameters are lipid profile after 2 years in a structured multidisciplinary program for patients with diabetes
Time frame: 2 years
Renal function after 2 years in a structured multidisciplinary program for patients with diabetes
Time frame: 2 years
Self-care by SDSCA questionnaire after 2 years in a structured multidisciplinary program for patients with diabetes
Time frame: 2 years
Diabetic complications are eye, renal and foot after 2 years in a structured multidisciplinary program for patients with diabetes
Time frame: 2 years
Quality of life after 2 years in a structured multidisciplinary program for patients with diabetes
Time frame: 2 years
Metabolic parameters are lipid profile after 4 visits in a structured multidisciplinary program for patients with diabetes
Time frame: 3 months
Renal function after 4 visits in a structured multidisciplinary program for patients with diabetes
Time frame: 3 months
Self-care by SDSCA questionnaire after 4 visits in a structured multidisciplinary program for patients with diabetes
Time frame: 3 months
Diabetic complications are eye, renal and foot evaluations after 4 visits in a structured multidisciplinary program for patients with diabetes
Time frame: 3 months
Quality of life after 4 visits in a structured multidisciplinary program for patients with diabetes
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Background: PubMed 20585732Villalpando S, Shamah-Levy T, Rojas R, Aguilar-Salinas CA. Trends for type 2 diabetes and other cardiovascular risk factors in Mexico from 1993-2006. Salud Publica Mex. 2010;52 Suppl 1:S72-9. doi: 10.1590/s0036-36342010000700011.
- BackgroundAguilar Salinas CA, Gómez Diaz RA, Gomez Perez FJ. Diabetes en Mexico: Principales retos y posibles soluciones. Revista ALAD 2011: 19:146-161
- Background: PubMed 22683130Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012 Jun 16;379(9833):2252-61. doi: 10.1016/S0140-6736(12)60480-2. Epub 2012 Jun 9.
- Background: PubMed 23224336Planas LG, Crosby KM, Farmer KC, Harrison DL. Evaluation of a diabetes management program using selected HEDIS measures. J Am Pharm Assoc (2003). 2012;52(6):e130-8. doi: 10.1331/JAPhA.2012.11148.
- Background: PubMed 25381833Hernandez-Jimenez S, Garcia-Ulloa C, Mehta R, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D. Innovative models for the empowerment of patients with type 2 diabetes: the CAIPaDi program. Recent Pat Endocr Metab Immune Drug Discov. 2014;8(3):202-9. doi: 10.2174/1872214808999141110155515.
- Derived from this study: PubMed 39494309Landa-Anell MV, Del Razo-Olvera FM, Bodnar I, Cordova-Isidro B, Lagunas-Valdepena D, Arias-Marroquin AT, Garcia-Ulloa AC, Melgarejo-Hernandez MA, Hernandez-Jimenez S; Group of Study CAIPaDi. Nutritional diagnoses in people with type 2 diabetes: association with metabolic, anthropometric, and dietary parameters. Front Nutr. 2024 Oct 18;11:1473429. doi: 10.3389/fnut.2024.1473429. eCollection 2024.
- Derived from this study: PubMed 36521878Garcia-Ulloa AC, Almeda-Valdes P, Cuatecontzi-Xochitiotzi TE, Ramirez-Garcia JA, Diaz-Pineda M, Garnica-Carrillo F, Gonzalez-Duarte A, Narayan KMV, Aguilar-Salinas CA, Hernandez-Jimenez S; CAIPaDi Study Group. Detection of sudomotor alterations evaluated by Sudoscan in patients with recently diagnosed type 2 diabetes. BMJ Open Diabetes Res Care. 2022 Dec;10(6):e003005. doi: 10.1136/bmjdrc-2022-003005.
- Derived from this study: PubMed 33568360Garcia-Ulloa AC, Lechuga-Fonseca C, Del Razo-Olvera FM, Aguilar-Salinas CA, Galaviz KI, Narayan KMV, Hernandez-Jimenez S; Group of Study CAIPaDi. Clinician prescription of lipid-lowering drugs and achievement of treatment goals in patients with newly diagnosed type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e001891. doi: 10.1136/bmjdrc-2020-001891.
- Individual participant dataSharing planned: Yes. Journal publication. The information to be shared will be metabolic parameters and questionaire results. The data will be available on 2016. Metabolic parameters will be obtained from blood samples and the questionnaires results from those self-applied or applied during praxis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio C Hernández, MD principal investigator
National Institute of Medical Sciences and Nutrition Salvador Zubirán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAIPaDi in people with Type 2 Diabetes, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Hernández, MD (57870900 ext. 5045, sergiohdzj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836808, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.