Diabetes Mellitus, Type 2CEADNCT04560062
Contextualizing the Evidence for Action on Diabetes - Cohort
An observational study of Diabetes Mellitus, Type 2, run by Universidad Miguel Hernandez de Elche at 1 site in Ecuador.
Trial summary
This protocol reflects the second part of a larger mixed-methods study aimed at exploring the process by which global recommendations can be translated into context-specific, evidence-informed action for diabetes prevention in low-resource settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Spontaneous changes in diabetes-related health care
- How many people
- 1,152 participants
- Where
- 1 siteEcuador
- Study dates
- 13 Oct 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The CEAD project will be carried out in 2 low-resource settings in Ecuador: 1) District 17D06, South Quito, an urban health district ; and 2) District 08D02, Eloy Alfaro District, in Esmeraldas Province, a rural area in the northern coastal region of the country.
Who may be able to join
- Individuals diagnosed with type-2 diabetes.
- Age over 18 years.
- Patients are accessing diabetes care in health facilities in the study districts.
- Providing informed consent
Who cannot join
- Unability to provide informed consent (e.g. significant mental impairment).
- Pregnant women if they are diagnosed with gestational diabetes.
Trial locations and contacts
1 site in 1 country.
Mari Carmen Bernal Soriano contact
Ecuador1 site, 1 recruiting
- Recruiting
Mari Carmen Bernal Soriano
Esmeraldas, 080102
Mari Carmen Bernal Soriano, maria.bernals@umh.es
About this study
Official title: Contextualizing Evidence for Action on Diabetes in Low-resource Settings: a Mixed-methods Case Study in Quito and Esmeraldas, Ecuador.
This protocol reflects the second part of a larger mixed-methods study aimed at exploring the process by which global recommendations can be translated into context-specific, evidence-informed action for diabetes prevention in low-resource settings. Firstly, a retrospective cohort study will assess the current level of implementation of comprehensive diabetes care over a 24-month period (2019-2020), by describing healthcare received and health outcomes of a representative sample of diabetes patients currently accessing care in the study region. Focus groups prompted by the findings of the retrospective study will be used to inspire local innovations which will be evaluated through a prospective follow-up of the cohort.
Read the detailed description
Objective: To evaluate the implementation of comprehensive diabetes care in two low-resource settings in Ecuador.
Specific objectives:
- To assess patient outcomes including biochemical diabetes control and health-related quality of life.
- To evaluate diabetes-related health care access.
- To assess complications related to diabetes.
Sample size: The sample size is proposed conservatively to ensure a precision to estimate outcomes of 50% with an absolute precision of ±5%, assuming a design effect of 1.2 and potential loss of 20%.
Sample design: A representative sample for each district will be obtained by stratified single-stage cluster sampling. The clusters are health facilities for which a sample of patients will randomly selected. The sample will be stratified by facility type (Ministry of Public Health (MSP) facilities, or Social Security facilities for affiliated workers) in Quito and by Rural/Urban setting in Esmeraldas. Patient sampling will use the electronic consultation registry of each selected facility where possible. Data unavailable in the electronic registers will be extracted from any available paper files.
Data collection procedure: Research assistants will obtain the data mainly from health services records, which will be supplemented by patient interviews including socio-demographic and clinical data, perceived social support (the Multidimensional Scale of Perceived Social Support, MSPSS) and health-related quality of life (the Diabetes Health Profile-18, DHP-18) profile. They will collect data regarding whether the patient received regular review by a clinician, and underwent screening for diabetes complications as recommended in the 2017 Clinical Practice Guideline for Type 2 Diabetes in Ecuador. He/she will record the date and details of any complications and experiences over the course of the evaluation and other clinical data such as comorbidities, treatments or patient management by a multidisciplinary health care team.
The first data collection will be retrospective and will include diabetes-related health care and clinical outcomes during 2019 and 2020. Clinical files will be reviewed every 12 months for the duration of follow-up (2 years). Supplementary interview data will be assessed on a baseline and in the last 6 months of follow-up.
Analysis: The researchers will calculate the proportion of patients that received care as per the clinical practice guideline (CPG) recommendations and/or the proportion receiving an intermediate level of care (as required). Proportions will be described with 95% confidence intervals. Variation in healthcare received and diabetes-related health will be described using sociodemographic and clinical characteristics of the patients to highlight potential inequities. A multivariate logistic regression model may be used to explore the relationship between the primary outcomes and socioeconomic explanatory variable and/or type of health facility. If necessary, the researchers will adjust for potential confounders such as patients' factors (e.g. sex, age, comorbidity, perceived social support) and/or environmental factors (e.g. proximity to the health centre, availability of different medical specialties or methods as laboratory test). Statistical analysis will be performed using Stata/SE (StataCorp, College Station, TX, USA) Version 15.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Spontaneous changes in diabetes-related health care
- Keywords
- Implementation science, Delivery of Health Care, Public Policy, Non-communicable Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous changes in diabetes-related health careOther
The findings of a retrospective cohort analysis conducted in the initial phase of the study will be used in focus groups to identify observed weaknesses in local health systems and will promote possible solutions to strengthen diabetes-related health care. Every focus group will include community members, healthcare workers, decision-makers and diabetic patients and family members.
| Study group | Role | What they receive |
|---|---|---|
| Population in Quito | 576 randomly chosen patients with diabetes in District 17D06, Quito (Ecuador) Receives: Other: Spontaneous changes in diabetes-related health care | |
| Population in Esmeraldas | 576 randomly chosen patients with diabetes in Eloy Alfaro District, Esmeraldas (Ecuador) Receives: Other: Spontaneous changes in diabetes-related health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with biochemically controlled disease
Proportions of patients with controlled disease along with 95% confidence interval.
Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Measured: Year 1
Proportion of patients with biochemically controlled disease
Proportions of patients with controlled disease along with 95% confidence interval.
Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Measured: Year 2
Proportion of patients with biochemically controlled disease
Proportions of patients with controlled disease along with 95% confidence interval.
Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Measured: Year 3
Proportion of patients with biochemically controlled disease
Proportions of patients with controlled disease along with 95% confidence interval.
Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Measured: Year 4
Proportion of patients with optimal health-related quality of life
Health-related quality of life will be obtained with Diabetes Health Profile-18 (DHP-18) questionnaire. DHP-18 scores range from 0 to 100, with 0 representing no dysfunction and 100 maximum dysfunction.
Proportion of patients with total final score under the median, meaning lower dysfunction, along with 95% confidence interval.
Measured: Year 3
Proportion of patients with optimal health-related quality of life
Health-related quality of life will be obtained with Diabetes Health Profile-18 (DHP-18) questionnaire. DHP-18 scores range from 0 to 100, with 0 representing no dysfunction and 100 maximum dysfunction.
Proportion of patients with total final score under the median, meaning lower dysfunction, along with 95% confidence interval.
Measured: Year 4
Proportion of patients with access to health care of diabetes
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Measured: Year 1
Proportion of patients with access to health care of diabetes
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Measured: Year 2
Proportion of patients with access to health care of diabetes
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Measured: Year 3
Proportion of patients with access to health care of diabetes
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Measured: Year 4
Secondary outcomes (32)
Perceived social support
Results of the standardized questionnaire "the Multidimensional Scale of Perceived Social Support (MSPSS)". The response format is a four-point Likert type scale (1= rarely, 2= sometimes, 3=frequently, 4= always or almost always). A higher score implies a greater perception of social support.
Tertiles of total final score will be used to measure low, medium and high social support. The investigators will report the patient ratio and 95% confidence interval for each category of social support
Measured: Year 3
Perceived social support
Results of the standardized questionnaire "the Multidimensional Scale of Perceived Social Support (MSPSS)". The response format is a four-point Likert type scale (1= rarely, 2= sometimes, 3=frequently, 4= always or almost always). A higher score implies a greater perception of social support.
Tertiles of total final score will be used to measure low, medium and high social support. The investigators will report the patient ratio and 95% confidence interval for each category of social support.
Measured: Year 4
Proportion of patients who diabetes-related education received
Self-reported information [dichotomous (yes/no) responses]. Proportion of patients who indicate that they have received information on diabetes and healthy habits, along with 95% confidence interval.
Measured: Year 3
Proportion of patients who diabetes-related education received
Self-reported information [dichotomous (yes/no) responses]. Proportion of patients who indicate that they have received information on diabetes and healthy habits, along with 95% confidence interval.
Measured: Year 4
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Proportions along with 95% confidence interval.
Measured: Year 1
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Proportions along with 95% confidence interval.
Measured: Year 2
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Proportions along with 95% confidence interval.
Measured: Year 3
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Proportions along with 95% confidence interval.
Measured: Year 4
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Proportions along with 95% confidence interval.
Measured: Year 1
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Proportions along with 95% confidence interval.
Measured: Year 2
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Proportions along with 95% confidence interval.
Measured: Year 3
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Proportions along with 95% confidence interval.
Measured: Year 4
Proportion of patients with LDL cholesterol level < 100 mg/dl
Proportions along with 95% confidence interval.
Measured: Year 1
Proportion of patients with LDL cholesterol level < 100 mg/dl
Proportions along with 95% confidence interval.
Measured: Year 2
Proportion of patients with LDL cholesterol level < 100 mg/dl
Proportions along with 95% confidence interval.
Measured: Year 3
Proportion of patients with LDL cholesterol level < 100 mg/dl
Proportions along with 95% confidence interval.
Measured: Year 4
Proportion of patients with microalbuminuria level <30 mg/day
Proportions along with 95% confidence interval.
Measured: Year 1
Proportion of patients with microalbuminuria level <30 mg/day
Proportions along with 95% confidence interval.
Measured: Year 2
Proportion of patients with microalbuminuria level <30 mg/day
Proportions along with 95% confidence interval.
Measured: Year 3
Proportion of patients with microalbuminuria level <30 mg/day
Proportions along with 95% confidence interval.
Measured: Year 4
Number of unscheduled diabetes-related consultations
Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 1
Number of unscheduled diabetes-related consultations
Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 2
Number of unscheduled diabetes-related consultations
Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 3
Number of unscheduled diabetes-related consultations
Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 4
Number of hospitalisations due to diabetes complications
Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 1
Number of hospitalisations due to diabetes complications
Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 2
Number of hospitalisations due to diabetes complications
Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 3
Number of hospitalisations due to diabetes complications
Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.
Measured: Year 4
Proportion of patients with at least one disease complication
Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.
Proportion along with 95% confidence interval.
Measured: Year 1
Proportion of patients with at least one disease complication
Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.
Proportion along with 95% confidence interval.
Measured: Year 2
Proportion of patients with at least one disease complication
Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.
Proportion along with 95% confidence interval.
Measured: Year 3
Proportion of patients with at least one disease complication
Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.
Proportion along with 95% confidence interval.
Measured: Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start13 Oct 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council, Pontificia Universidad Católica del Ecuador, Centro de Epidemiología Comunitaria y Medicina Tropical
- Responsible party
- Principal investigator, Lucy Anne Parker, Universidad Miguel Hernandez de Elche
- Investigators
- Lucy A Parker, PhD, Principal investigator, University Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560062
- Sponsor's protocol ID
- ERC-2018-STG-804761.2
- Acronym
- CEAD
- Status last verified
- Jan 2021
- First submitted
- 27 Aug 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This research is part of a European Research Council Grant and we are participating in the Open Data Research Plan.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contextualizing Evidence for Action on Diabetes in Low-resource Settings: a Mixed-methods Case Study in Quito and Esmeraldas, Ecuador.
- ClinicalTrials.gov ID
- NCT04560062
- Acronym / sponsor ID
- CEAD / ERC-2018-STG-804761.2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Implementation science, Delivery of Health Care, Public Policy, Non-communicable Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,152 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- European Research Council, Pontificia Universidad Católica del Ecuador, Centro de Epidemiología Comunitaria y Medicina Tropical
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Sep 2020 (actual)
- 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.
This protocol reflects the second part of a larger mixed-methods study aimed at exploring the process by which global recommendations can be translated into context-specific, evidence-informed action for diabetes prevention in low-resource settings. Firstly, a retrospective cohort study will assess the current level of implementation of comprehensive diabetes care over a 24-month period (2019-2020), by describing healthcare received and health outcomes of a representative sample of diabetes patients currently accessing care in the study region. Focus groups prompted by the findings of the retrospective study will be used to inspire local innovations which will be evaluated through a prospective follow-up of the cohort.
Detailed description
Objective: To evaluate the implementation of comprehensive diabetes care in two low-resource settings in Ecuador.
Specific objectives:
- To assess patient outcomes including biochemical diabetes control and health-related quality of life.
- To evaluate diabetes-related health care access.
- To assess complications related to diabetes.
Sample size: The sample size is proposed conservatively to ensure a precision to estimate outcomes of 50% with an absolute precision of ±5%, assuming a design effect of 1.2 and potential loss of 20%.
Sample design: A representative sample for each district will be obtained by stratified single-stage cluster sampling. The clusters are health facilities for which a sample of patients will randomly selected. The sample will be stratified by facility type (Ministry of Public Health (MSP) facilities, or Social Security facilities for affiliated workers) in Quito and by Rural/Urban setting in Esmeraldas. Patient sampling will use the electronic consultation registry of each selected facility where possible. Data unavailable in the electronic registers will be extracted from any available paper files.
Data collection procedure: Research assistants will obtain the data mainly from health services records, which will be supplemented by patient interviews including socio-demographic and clinical data, perceived social support (the Multidimensional Scale of Perceived Social Support, MSPSS) and health-related quality of life (the Diabetes Health Profile-18, DHP-18) profile. They will collect data regarding whether the patient received regular review by a clinician, and underwent screening for diabetes complications as recommended in the 2017 Clinical Practice Guideline for Type 2 Diabetes in Ecuador. He/she will record the date and details of any complications and experiences over the course of the evaluation and other clinical data such as comorbidities, treatments or patient management by a multidisciplinary health care team.
The first data collection will be retrospective and will include diabetes-related health care and clinical outcomes during 2019 and 2020. Clinical files will be reviewed every 12 months for the duration of follow-up (2 years). Supplementary interview data will be assessed on a baseline and in the last 6 months of follow-up.
Analysis: The researchers will calculate the proportion of patients that received care as per the clinical practice guideline (CPG) recommendations and/or the proportion receiving an intermediate level of care (as required). Proportions will be described with 95% confidence intervals. Variation in healthcare received and diabetes-related health will be described using sociodemographic and clinical characteristics of the patients to highlight potential inequities. A multivariate logistic regression model may be used to explore the relationship between the primary outcomes and socioeconomic explanatory variable and/or type of health facility. If necessary, the researchers will adjust for potential confounders such as patients' factors (e.g. sex, age, comorbidity, perceived social support) and/or environmental factors (e.g. proximity to the health centre, availability of different medical specialties or methods as laboratory test). Statistical analysis will be performed using Stata/SE (StataCorp, College Station, TX, USA) Version 15.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population in Quito | – | Other: Spontaneous changes in diabetes-related health care576 randomly chosen patients with diabetes in District 17D06, Quito (Ecuador) |
| Population in Esmeraldas | – | Other: Spontaneous changes in diabetes-related health care576 randomly chosen patients with diabetes in Eloy Alfaro District, Esmeraldas (Ecuador) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CEAD project will be carried out in 2 low-resource settings in Ecuador: 1) District 17D06, South Quito, an urban health district ; and 2) District 08D02, Eloy Alfaro District, in Esmeraldas Province, a rural area in the northern coastal region of the country.
Key inclusion criteria (4 listed)
- Individuals diagnosed with type-2 diabetes.
- Age over 18 years.
- Patients are accessing diabetes care in health facilities in the study districts.
- Providing informed consent
Key exclusion criteria (2 listed)
- Unability to provide informed consent (e.g. significant mental impairment).
- Pregnant women if they are diagnosed with gestational diabetes.
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 |
|---|---|---|
| Spontaneous changes in diabetes-related health careThe findings of a retrospective cohort analysis conducted in the initial phase of the study will be used in focus groups to identify observed weaknesses in local health systems and will promote possible solutions to strengthen diabetes-related health care. Every focus group will include community members, healthcare workers, decision-makers and diabetic patients and family members. | Other | Population in Esmeraldas, Population in Quito |
Primary outcome
Proportion of patients with biochemically controlled disease
Time frame: Year 1
Proportions of patients with controlled disease along with 95% confidence interval. Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Proportion of patients with biochemically controlled disease
Time frame: Year 2
Proportions of patients with controlled disease along with 95% confidence interval. Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Proportion of patients with biochemically controlled disease
Time frame: Year 3
Proportions of patients with controlled disease along with 95% confidence interval. Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Proportion of patients with biochemically controlled disease
Time frame: Year 4
Proportions of patients with controlled disease along with 95% confidence interval. Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if ≥15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.
Proportion of patients with optimal health-related quality of life
Time frame: Year 3
Health-related quality of life will be obtained with Diabetes Health Profile-18 (DHP-18) questionnaire. DHP-18 scores range from 0 to 100, with 0 representing no dysfunction and 100 maximum dysfunction. Proportion of patients with total final score under the median, meaning lower dysfunction, along with 95% confidence interval.
Proportion of patients with optimal health-related quality of life
Time frame: Year 4
Health-related quality of life will be obtained with Diabetes Health Profile-18 (DHP-18) questionnaire. DHP-18 scores range from 0 to 100, with 0 representing no dysfunction and 100 maximum dysfunction. Proportion of patients with total final score under the median, meaning lower dysfunction, along with 95% confidence interval.
Proportion of patients with access to health care of diabetes
Time frame: Year 1
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Proportion of patients with access to health care of diabetes
Time frame: Year 2
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Proportion of patients with access to health care of diabetes
Time frame: Year 3
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
Proportion of patients with access to health care of diabetes
Time frame: Year 4
It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.
32 secondary outcomes
Perceived social support
Time frame: Year 3
Perceived social support
Time frame: Year 4
Proportion of patients who diabetes-related education received
Time frame: Year 3
Proportion of patients who diabetes-related education received
Time frame: Year 4
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Time frame: Year 1
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Time frame: Year 2
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Time frame: Year 3
Proportion of patients with blood pressure controlled (<140/90 mmHg)
Time frame: Year 4
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Time frame: Year 1
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Time frame: Year 2
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Time frame: Year 3
Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
Time frame: Year 4
Proportion of patients with LDL cholesterol level < 100 mg/dl
Time frame: Year 1
Proportion of patients with LDL cholesterol level < 100 mg/dl
Time frame: Year 2
Proportion of patients with LDL cholesterol level < 100 mg/dl
Time frame: Year 3
Proportion of patients with LDL cholesterol level < 100 mg/dl
Time frame: Year 4
Proportion of patients with microalbuminuria level <30 mg/day
Time frame: Year 1
Proportion of patients with microalbuminuria level <30 mg/day
Time frame: Year 2
Proportion of patients with microalbuminuria level <30 mg/day
Time frame: Year 3
Proportion of patients with microalbuminuria level <30 mg/day
Time frame: Year 4
Number of unscheduled diabetes-related consultations
Time frame: Year 1
Number of unscheduled diabetes-related consultations
Time frame: Year 2
Number of unscheduled diabetes-related consultations
Time frame: Year 3
Number of unscheduled diabetes-related consultations
Time frame: Year 4
Number of hospitalisations due to diabetes complications
Time frame: Year 1
Number of hospitalisations due to diabetes complications
Time frame: Year 2
Number of hospitalisations due to diabetes complications
Time frame: Year 3
Number of hospitalisations due to diabetes complications
Time frame: Year 4
Proportion of patients with at least one disease complication
Time frame: Year 1
Proportion of patients with at least one disease complication
Time frame: Year 2
Proportion of patients with at least one disease complication
Time frame: Year 3
Proportion of patients with at least one disease complication
Time frame: Year 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Individual participant dataSharing planned: Yes. This research is part of a European Research Council Grant and we are participating in the Open Data Research Plan.
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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. This study is not recruiting at the moment.
Mari Carmen Bernal Soriano contact
Lucy A Parker, PhD principal investigator
University Miguel Hernández
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Universidad Miguel Hernandez de Elche at 1 site in Ecuador.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. 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 Ecuador. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Anne Parker (+34 965919516, lparker@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with biochemically controlled disease (time frame: Year 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.