<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835195</url>
  </required_header>
  <id_info>
    <org_study_id>AIDDA</org_study_id>
    <nct_id>NCT03835195</nct_id>
  </id_info>
  <brief_title>Comprehensive Care in Type 1 Diabetes and Associated Outcomes</brief_title>
  <acronym>AIDDA</acronym>
  <official_title>Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Antioquia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Antioquia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quasi-experimental, retrospective, before and after study, with a control group, to evaluate&#xD;
      the effect of an intervention based on disease management, on metabolic control and&#xD;
      hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider&#xD;
      Institution of Health Services of the city of Medellin - Colombia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the effect of an intervention based on the management of the disease, on metabolic&#xD;
      control and the number of hospitalizations related to diabetes, in a group of patients with&#xD;
      Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of&#xD;
      Medellin - Colombia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in HbA1C value after the intervention</measure>
    <time_frame>4-9 months</time_frame>
    <description>It was considered as a measure of the before. The last glycated hemoglobin of the patient before starting care in the health institution, when his measurement time was not more than 6 months.&#xD;
Otherwise, the value of the first HbA1C measured in the first 15 days of admission to the health institution was considered, since it reflects the level of basal glycemic control, with which the patient was referred to the institution. The post-intervention measurement corresponded to the last HbA1C measured at 4-9 months of follow-up in the institution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients diagnosed with dyslipidemia after the intervention</measure>
    <time_frame>4-9 months</time_frame>
    <description>The measurement of the previous one corresponded to the diagnosis of dyslipidemia reported in the patient's clinical history before starting care in the institution. The postintervention measurement corresponded to the diagnosis of dyslipidemia reported in the clinical history at 4-9 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with hypoglycaemia after the intervention</measure>
    <time_frame>4-9 months</time_frame>
    <description>The measurement of the before, corresponded to the report of at least one hypoglycaemia in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the report of hypoglycaemia in the clinical history at 4-9 months.&#xD;
The measurement of the previous one corresponded to the diagnosis of HBP reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations associated with diabetes, after the intervention</measure>
    <time_frame>4-9 months</time_frame>
    <description>The measurement of the before, corresponded to the number of hospitalizations associated with diabetes, in the year prior to admission to the institution. The measurement afterwards corresponded to the measurement of hospitalizations during the Clid follow-up and in the subsequent 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients diagnosed with hypertension after the intervention</measure>
    <time_frame>4-9 months</time_frame>
    <description>The measurement of the previous one corresponded to the diagnosis of High Blood Pressure reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the body mass index after the intervention</measure>
    <time_frame>4-9 months</time_frame>
    <description>The measure corresponds to the records in the admission consultation (before) and in the consultation at 4-9 months (after) in the institution.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Diabetes Disease Management Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes Disease Management Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Process</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care process</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diabetes Disease Management Program</intervention_name>
    <description>The attention is carried out in a single physical place, in the city of Medellin. The scheme of intervention in the comprehensive Diabetes Clinic is based on the concept of disease management. The intervention is composed of 5 phases, which apply to all the patients cared for in the institution (access, reception, entry, clinical consultation, management plan, education, pharmaceutical care). The healthcare team consists of 5 endocrinologists, an endocrinologist pediatrician, 7 general practitioners trained in diabetes, 5 pharmacists trained in diabetes and certified in education for patients with diabetes and 3 nutritionists.</description>
    <arm_group_label>Diabetes Disease Management Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care Process</intervention_name>
    <description>The patients are treated in the cardiovascular risk clinic (general practitioners) of their Primary Healthcare Provider Institution or by specialists in internal medicine, pediatrics or endocrinology in the different Provider Institutions of Health Services of the insurance service network of health or in private doctors' offices assigned to the insurer. In some cases there is assisted consultation (general practitioner - specialist). There is no defined periodicity for follow-up; Appointments are assigned to need, according to the criteria of the treating physicians. In some cases there is remission to educational activities, not necessarily focused on type 1 diabetes.</description>
    <arm_group_label>Usual Care Process</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with type 1 diabetes.&#xD;
&#xD;
          -  Patients affiliated to the Entity Administrator of Health Benefits Plans (EPS Sura)&#xD;
&#xD;
          -  Patients with age greater than or equal to 15 years, who had been referred to the&#xD;
             institution at the discretion of the treating physician, for poor metabolic control&#xD;
             and had to enter a hemoglobin glycated (HbA1C) ≥ 7.0%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who at the time of recruitment were treated with continuous insulin infusion&#xD;
             device (insulin pump) and patients with gestational diabetes were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Jairo Zuleta Tobón, MD, Msc</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Antioquia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clínica Integral de Diabetes</name>
      <address>
        <city>Medellín</city>
        <state>Antioquia</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>June 5, 2019</last_update_submitted>
  <last_update_submitted_qc>June 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835195
org study id: AIDDA
nct id: NCT03835195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Quasi-experimental, retrospective, before and after study, with a control group, to evaluate
      the effect of an intervention based on disease management, on metabolic control and
      hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider
      Institution of Health Services of the city of Medellin - Colombia.
Evaluate the effect of an intervention based on the management of the disease, on metabolic
      control and the number of hospitalizations related to diabetes, in a group of patients with
      Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of
      Medellin - Colombia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Differences in HbA1C value after the intervention
time frame: 4-9 months
description: It was considered as a measure of the before. The last glycated hemoglobin of the patient before starting care in the health institution, when his measurement time was not more than 6 months.
Otherwise, the value of the first HbA1C measured in the first 15 days of admission to the health institution was considered, since it reflects the level of basal glycemic control, with which the patient was referred to the institution. The post-intervention measurement corresponded to the last HbA1C measured at 4-9 months of follow-up in the institution.
measure: Proportion of patients diagnosed with dyslipidemia after the intervention
time frame: 4-9 months
description: The measurement of the previous one corresponded to the diagnosis of dyslipidemia reported in the patient's clinical history before starting care in the institution. The postintervention measurement corresponded to the diagnosis of dyslipidemia reported in the clinical history at 4-9 months.
measure: Proportion of patients with hypoglycaemia after the intervention
time frame: 4-9 months
description: The measurement of the before, corresponded to the report of at least one hypoglycaemia in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the report of hypoglycaemia in the clinical history at 4-9 months.
The measurement of the previous one corresponded to the diagnosis of HBP reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months.
measure: Number of hospitalizations associated with diabetes, after the intervention
time frame: 4-9 months
description: The measurement of the before, corresponded to the number of hospitalizations associated with diabetes, in the year prior to admission to the institution. The measurement afterwards corresponded to the measurement of hospitalizations during the Clid follow-up and in the subsequent 6 months.
measure: Proportion of patients diagnosed with hypertension after the intervention
time frame: 4-9 months
description: The measurement of the previous one corresponded to the diagnosis of High Blood Pressure reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months.
measure: Difference in the body mass index after the intervention
time frame: 4-9 months
description: The measure corresponds to the records in the admission consultation (before) and in the consultation at 4-9 months (after) in the institution.
arm group label: Diabetes Disease Management Program
arm group type: Experimental
description: Diabetes Disease Management Program
arm group label: Usual Care Process
arm group type: Active Comparator
description: Usual care process
intervention type: Other
intervention name: Diabetes Disease Management Program
description: The attention is carried out in a single physical place, in the city of Medellin. The scheme of intervention in the comprehensive Diabetes Clinic is based on the concept of disease management. The intervention is composed of 5 phases, which apply to all the patients cared for in the institution (access, reception, entry, clinical consultation, management plan, education, pharmaceutical care). The healthcare team consists of 5 endocrinologists, an endocrinologist pediatrician, 7 general practitioners trained in diabetes, 5 pharmacists trained in diabetes and certified in education for patients with diabetes and 3 nutritionists.
arm group label: Diabetes Disease Management Program
intervention type: Other
intervention name: Usual Care Process
description: The patients are treated in the cardiovascular risk clinic (general practitioners) of their Primary Healthcare Provider Institution or by specialists in internal medicine, pediatrics or endocrinology in the different Provider Institutions of Health Services of the insurance service network of health or in private doctors' offices assigned to the insurer. In some cases there is assisted consultation (general practitioner - specialist). There is no defined periodicity for follow-up; Appointments are assigned to need, according to the criteria of the treating physicians. In some cases there is remission to educational activities, not necessarily focused on type 1 diabetes.
arm group label: Usual Care Process
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: John Jairo Zuleta Tobón, MD, Msc
role: Study Director
affiliation: Universidad de Antioquia
facility: 
country: Colombia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No