<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/NCT03793283</url>
  </required_header>
  <id_info>
    <org_study_id>C-225</org_study_id>
    <nct_id>NCT03793283</nct_id>
  </id_info>
  <brief_title>Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice</brief_title>
  <acronym>real-ECIMI</acronym>
  <official_title>Effectiveness and Safety of Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult Patients in Routine Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Castilla-La Mancha Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de Córdoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Castilla-La Mancha Health Service</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>
      Observational study about effectiveness and safety of continuous subcutaneous insulin&#xD;
      infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM)&#xD;
      adult patients in routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin&#xD;
      infusion compared to multiple dose insulin injections in T1DM adult patients in routine&#xD;
      clinical practice.&#xD;
&#xD;
      All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®,&#xD;
      Emminens eConecta® and FreeStyle Libre®).&#xD;
&#xD;
      Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are&#xD;
      presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon&#xD;
      signed-rank test were used for the analysis of differences. Comparisons between proportions&#xD;
      were analyzed using a chi-squared test. A P value &lt; 0.05 was considered statistically&#xD;
      significant.&#xD;
&#xD;
      The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic&#xD;
      Committee. All participants provided written informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of Hemoglobin A1C (HbA1C).</measure>
    <time_frame>1 year</time_frame>
    <description>Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia frequency.</measure>
    <time_frame>1 year</time_frame>
    <description>Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values &lt;70 mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Capillary blood glucose.</measure>
    <time_frame>1 year</time_frame>
    <description>Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Interstitial blood glucose.</measure>
    <time_frame>1 year</time_frame>
    <description>Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.</measure>
    <time_frame>1 year</time_frame>
    <description>Glycemic variability expressed as coefficient of variation of capilary/interstitial blood glucose.&#xD;
Physiological parameter. Unit of measure: %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability: standar deviation of capilary/interstitial blood glucose.</measure>
    <time_frame>1 year</time_frame>
    <description>Glycemic variability expressed as standar deviation of capilary/interstitial blood glucose.&#xD;
Physiological parameter. Unit of measure: mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-monitoring of blood glucose (SMBG) daily frequency</measure>
    <time_frame>1 year</time_frame>
    <description>Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe hypoglycemia frequency.</measure>
    <time_frame>1 year</time_frame>
    <description>Number of events during the last year of severe hypoglycemia frequency defined as any glycemic value &lt;70 mg/dL requiring assitance from another person to treat.&#xD;
Unit of measure: number of events during the last 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight.</measure>
    <time_frame>1 year</time_frame>
    <description>Between group weight differences. Physiological parameter. Unit of measure: Kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insuline dose.</measure>
    <time_frame>1 year</time_frame>
    <description>Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes quality of life (DQOL).</measure>
    <time_frame>1 year.</time_frame>
    <description>Diabetes related quality of life (EsDQOL questionnary). Spanihs version of DQOL questionnary. Unit of measure: Questionnary score. Higher values represent a worse outcome. Forty-six questions in four categories: Satisfaction (15), Impact (20), Social/vacational worryness (7) and Diabetes related worryness (4). Each question score from 1 to 5 points.&#xD;
Total minimum score 46, total maximum score 230. Satisfaction range from 15 to 75, Impact range from 20 to 100, Social/vacational worryness range from 7 to 35 and Diabetes related worryness range from 4 to 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable</measure>
    <time_frame>1 year</time_frame>
    <description>Satisfaction with the treatment received (Diabetes Treatment Satisfaction Questionnaire Stable, EsDTSQs questionnary).&#xD;
Spanish version of DTSQs questionnary. Unit of measure: Questionnary score. Higher values represent a better outcome. Eight questions with seven possible answers ranged each one from 0 to 6 points. First six questions compute a subscore ranged from 0 to 36 points. Two last questions are independtly analyzed (each one range from 0 to 6 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unawareness hypoglycemia.</measure>
    <time_frame>1 year.</time_frame>
    <description>Unawareness hypoglycemia frequency (Clarke questionnary). Unit of measure: Questionnary score. Higher values represent a worse outcome. Eight questions with each answer categorized in normal (A) or abnormal (R). Total sum of abnormal (R) answers classifed patients in normal perception (range from 0 to 2), indeterminate percepction (range=3) and abnormal perception (range from 4 to 8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety related adverse events.</measure>
    <time_frame>1 year</time_frame>
    <description>Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Continous Subcutaneous Insulin Infusion</arm_group_label>
    <description>All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.&#xD;
Forty-five patients are actually treated with CSII in our hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple dose insulin injections (MDI):</arm_group_label>
    <description>Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI.&#xD;
MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CSII</intervention_name>
    <description>Currently receiving CSII therapy during 6 or more months.</description>
    <arm_group_label>Continous Subcutaneous Insulin Infusion</arm_group_label>
    <other_name>Continuous subcutaneous insulin infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple dose insulin injections</intervention_name>
    <description>Currently receiving MDI therapy during 6 or more months.</description>
    <arm_group_label>Multiple dose insulin injections (MDI):</arm_group_label>
    <other_name>MDI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and&#xD;
        treated with CSII.&#xD;
&#xD;
        MDI patients will be selected through simple random sampling (1:1) from our T1DM patient&#xD;
        database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age.&#xD;
&#xD;
          -  Diagnosed of Type 1 Diabetes Mellitus.&#xD;
&#xD;
          -  Be attended in Ciudad Real General University Hospital.&#xD;
&#xD;
          -  Current treated with CSII (CSII cohort) or MDI (MDI cohort) during ≥6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old.&#xD;
&#xD;
          -  Other types of diabetes mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jesus Moreno-Fernandez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Castilla-La Mancha Public Health Service.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Obispo Rafael Torija, St.</name>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Castilla-La Mancha Health Service</investigator_affiliation>
    <investigator_full_name>Jesús Moreno Fernández</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
  </intervention_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/NCT03793283
org study id: C-225
nct id: NCT03793283
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study about effectiveness and safety of continuous subcutaneous insulin
      infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM)
      adult patients in routine clinical practice.
Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin
      infusion compared to multiple dose insulin injections in T1DM adult patients in routine
      clinical practice.

      All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®,
      Emminens eConecta® and FreeStyle Libre®).

      Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are
      presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon
      signed-rank test were used for the analysis of differences. Comparisons between proportions
      were analyzed using a chi-squared test. A P value < 0.05 was considered statistically
      significant.

      The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic
      Committee. All participants provided written informed consent.
observational model: Cohort
time perspective: Cross-Sectional
measure: Concentration of Hemoglobin A1C (HbA1C).
time frame: 1 year
description: Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
measure: Hypoglycemia frequency.
time frame: 1 year
description: Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.
measure: Concentration of Capillary blood glucose.
time frame: 1 year
description: Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
measure: Concentration of Interstitial blood glucose.
time frame: 1 year
description: Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
measure: Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.
time frame: 1 year
description: Glycemic variability expressed as coefficient of variation of capilary/interstitial blood glucose.
Physiological parameter. Unit of measure: %.
measure: Glycemic variability: standar deviation of capilary/interstitial blood glucose.
time frame: 1 year
description: Glycemic variability expressed as standar deviation of capilary/interstitial blood glucose.
Physiological parameter. Unit of measure: mg/dL.
measure: Self-monitoring of blood glucose (SMBG) daily frequency
time frame: 1 year
description: Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.
measure: Severe hypoglycemia frequency.
time frame: 1 year
description: Number of events during the last year of severe hypoglycemia frequency defined as any glycemic value <70 mg/dL requiring assitance from another person to treat.
Unit of measure: number of events during the last 12 months.
measure: Weight.
time frame: 1 year
description: Between group weight differences. Physiological parameter. Unit of measure: Kg.
measure: Insuline dose.
time frame: 1 year
description: Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.
measure: Diabetes quality of life (DQOL).
time frame: 1 year.
description: Diabetes related quality of life (EsDQOL questionnary). Spanihs version of DQOL questionnary. Unit of measure: Questionnary score. Higher values represent a worse outcome. Forty-six questions in four categories: Satisfaction (15), Impact (20), Social/vacational worryness (7) and Diabetes related worryness (4). Each question score from 1 to 5 points.
Total minimum score 46, total maximum score 230. Satisfaction range from 15 to 75, Impact range from 20 to 100, Social/vacational worryness range from 7 to 35 and Diabetes related worryness range from 4 to 20.
measure: Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable
time frame: 1 year
description: Satisfaction with the treatment received (Diabetes Treatment Satisfaction Questionnaire Stable, EsDTSQs questionnary).
Spanish version of DTSQs questionnary. Unit of measure: Questionnary score. Higher values represent a better outcome. Eight questions with seven possible answers ranged each one from 0 to 6 points. First six questions compute a subscore ranged from 0 to 36 points. Two last questions are independtly analyzed (each one range from 0 to 6 points).
measure: Unawareness hypoglycemia.
time frame: 1 year.
description: Unawareness hypoglycemia frequency (Clarke questionnary). Unit of measure: Questionnary score. Higher values represent a worse outcome. Eight questions with each answer categorized in normal (A) or abnormal (R). Total sum of abnormal (R) answers classifed patients in normal perception (range from 0 to 2), indeterminate percepction (range=3) and abnormal perception (range from 4 to 8).
measure: Safety related adverse events.
time frame: 1 year
description: Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.
arm group label: Continous Subcutaneous Insulin Infusion
description: All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.
Forty-five patients are actually treated with CSII in our hospital.
arm group label: Multiple dose insulin injections (MDI):
description: Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI.
MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
intervention type: Device
intervention name: CSII
description: Currently receiving CSII therapy during 6 or more months.
arm group label: Continous Subcutaneous Insulin Infusion
other name: Continuous subcutaneous insulin infusion
intervention type: Drug
intervention name: Multiple dose insulin injections
description: Currently receiving MDI therapy during 6 or more months.
arm group label: Multiple dose insulin injections (MDI):
other name: MDI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jesus Moreno-Fernandez, PhD
role: Principal Investigator
affiliation: Castilla-La Mancha Public Health Service.
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Castilla-La Mancha Health Service
investigator full name: Jesús Moreno Fernández
investigator title: Principal investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
sharing ipd: No