<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/NCT03763474</url>
  </required_header>
  <id_info>
    <org_study_id>Euglyca application</org_study_id>
    <nct_id>NCT03763474</nct_id>
  </id_info>
  <brief_title>Euglyca Application in Children and Adolescents With Type 1 Diabetes Mellitus</brief_title>
  <official_title>The Effect of Mobile Application Euglyca in Glycemic Control of Children and Adolescents With Diabetes Mellitus Type-1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      80 children and adolescents with Diabetes Mellitus Type 1 were enrolled in the study and were&#xD;
      randomly assigned in the intervention group (Euglyca group) or in the control group. Patients&#xD;
      in the Euglyca group were asked to use the application in order to calculate the bolus&#xD;
      insulin dose. Primary outcomes of the study were the Glycosylated hemoglobin, percentage of&#xD;
      normoglycemias and the Diabetes Treatment Satisfaction Questionnaire Score. Patients were&#xD;
      evaluated at the baseline, 3, 6 and 12 months after the beginning of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children and adolescents with Diabetes Mellitus Type 1 (T1DM) who visited consecutively this&#xD;
      clinic were asked to participate in the study if they owned an Android smartphone and were&#xD;
      familiar with its use. Patients were included after one of their parents or their legal&#xD;
      guardian signed an informed consent. Inclusion criteria were: 1. Treatment with multiple&#xD;
      daily injections (MDI) or continuous subcutaneous insulin infusion (CSII); 2. satisfactory&#xD;
      knowledge of the concept of carbohydrates and lipids counting acquired following previous&#xD;
      training by the physicians and nutritionist of the department at initial diagnosis and&#xD;
      thereafter during follow-up visits. Exclusion criteria were: 1. Use of another medical&#xD;
      application for diabetes in the previous 3 months; 2. lack of capacity of reading greek.&#xD;
&#xD;
      80 patients met the inclusion criteria and agreed to participate in the study. Subsequently&#xD;
      they were randomized to two equally numbered groups by drawing one of two nontransparent&#xD;
      envelopes which contained one ticket inscribed with either a E (for Euglyca group) or a C&#xD;
      (for Control group). To ensure equal allocation rates within the 2 groups, block&#xD;
      randomization was employed.&#xD;
&#xD;
      At the initial visit, patients randomized to the E group were advised to download the Euglyca&#xD;
      application on their smartphones and they were asked to use the application for the&#xD;
      calculation of the bolus insulin dose they were injected. Patients randomized to the C group&#xD;
      were advised to calculate bolus insulin dose they were injected, the way they used to do.&#xD;
      Patients repeated their visit to the endocrine pediatric clinic at 3, 6 and 12 months, the&#xD;
      latter set as the terminal time-point of this study following the initial visit. At all 4&#xD;
      visits, anthropometrics (weight, height, BMI), blood pressure measurement and heart rate were&#xD;
      noted down, while a peripheral blood sample was drawn from all patients in the morning of&#xD;
      each visit after an overnight fast for measurement of glycemia and glycosylated hemoglobin&#xD;
      (HbA1c) levels. Glucose measurements between 70 and 180 mg/dl were categorized as&#xD;
      normoglycemia; any glucose measurement below 70mg/dl was categorized as hypoglycemia; glucose&#xD;
      measurements at two hours postprandial measurement found above 180mg/dl were categorized as&#xD;
      hyperglycemia. At baseline (first visit), at 6 months (third visit) and at terminal&#xD;
      time-point (12 months) all patients filled the World Health Organization-Standard DTSQ.&#xD;
      Patients' logbooks and readings from their glucose meters were reviewed by the physicians and&#xD;
      nutritionist of the department at each of the four visits and the percentage of&#xD;
      normoglycemic, hypoglycemic and hyperglycemic episodes during the preceding trimester was&#xD;
      calculated for each patient. The change of HbA1c values from baseline to the terminal&#xD;
      time-point for each group was set as primary outcome, while the percentage of normoglycemic,&#xD;
      hypoglycemic and hyperglycemic events over the total number of glucose measurements during&#xD;
      the preceding trimester of each visit was set as secondary outcome.&#xD;
&#xD;
      Glycosylated hemoglobin was determined by Siemens DCA Vantage point-of-care immunoassay&#xD;
      analyzer (Siemens Health care Diagnostics Ltd., Frimley, Camberley, UK) with intra- and&#xD;
      inter- assay coefficients of variation (CV) 5% and 8%, respectively; glycemia was determined&#xD;
      by glucose god/pap kit with intra- and inter- assay CVs 5.7% and 7.8%, respectively.&#xD;
&#xD;
      'Euglyca' is a mobile application that we developed . The application has a data base of 7000&#xD;
      foods and food products met in greek eating habits as well as the corresponding amount of&#xD;
      carbohydrates and lipids for each of them. Subsequently, the amount of carbohydrates and&#xD;
      lipids contained in a meal are calculated automatically by the application. By taking into&#xD;
      consideration the amount of carbohydrates and lipids to be consumed, the preprandial and&#xD;
      target post-prandial glycemia concentrations, the insulin correction factor for the patient,&#xD;
      the carbohydrates and lipids factors and the active insulin (in case of CSII), 'Euglyca'&#xD;
      calculates the required bolus dose of insulin.&#xD;
&#xD;
      Sample size was determined by estimating the change in HbA1c values (primary outcome) based&#xD;
      on previous studies (7, 8), assuming 0.5% reduction in HbA1c in the intervention group with&#xD;
      80% power and 5% significance level. Power calculation resulted in 14 patients per group,&#xD;
      while the target of the study had been set at recruitment of 80 patients altogether. Results&#xD;
      are reported as mean ± standard deviation (SD) for quantitative variables. The absolute&#xD;
      difference in a quantitative variable between two different time points was defined as Δ. All&#xD;
      quantitative variables (HbA1c; ΔHbA1c; percentages of normoglycemic, hypoglycemic and&#xD;
      hyperglycemic events over a total number of glucose measurements; DTSQ's scores) were&#xD;
      normally distributed and they were compared between the two studied groups of patients at the&#xD;
      different time-points by employing General Linear Models ANOVA and Bonferroni post-hoc test.&#xD;
      Repeated measures ANOVA involved one factor between patients (factor &quot;Group&quot; with two levels)&#xD;
      and one factor for the repeated measures within patients (factor &quot;time&quot; with 4 or 3 levels&#xD;
      depending on the compared variable). Qualitative variables (gender and type of therapy) were&#xD;
      compared by employing x2 (chi square) test after having computed absolute and relative&#xD;
      frequencies (percentages %), Statistical significance was set at P&lt;0,05. An intention to&#xD;
      treat analysis was followed. IBM SPSS V23 Chicago, USA software was used for the statistical&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessors were blinded as for the allocation of the patients in the 2 groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Level of glycosylated hemoglobin in the 2 groups</measure>
    <time_frame>At 3 months after the baseline visit</time_frame>
    <description>Comparison of the level of glycosylated hemoglobin between the 2 groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of glycosylated hemoglobin in the 2 groups</measure>
    <time_frame>At 6 months after the baseline visit</time_frame>
    <description>Comparison of the level of glycosylated hemoglobin between the 2 groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of glycosylated hemoglobin in the 2 groups</measure>
    <time_frame>At 12 months after the baseline visit</time_frame>
    <description>Comparison of the level of glycosylated hemoglobin between the 2 groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline glycosylated hemoglobin at 3 months in the 2 groups</measure>
    <time_frame>At 3 months after the baseline visit</time_frame>
    <description>Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from 3 months glycosylated hemoglobin at 6 months in the 2 groups</measure>
    <time_frame>At 6 months after the baseline visit</time_frame>
    <description>Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from 6 months glycosylated hemoglobin at 12 months in the 2 groups</measure>
    <time_frame>At 12 months after the baseline visit</time_frame>
    <description>Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Normoglycemias in the 2 groups</measure>
    <time_frame>At 3 months after the baseline visit</time_frame>
    <description>Comparison of the percentage of Normoglycemias between the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Normoglycemias in the 2 groups</measure>
    <time_frame>At 6 months after the baseline visit</time_frame>
    <description>Comparison of the percentage of Normoglycemias between the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Normoglycemias in the 2 groups</measure>
    <time_frame>At 12 months after the baseline visit</time_frame>
    <description>Comparison of the percentage of Normoglycemias between the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups</measure>
    <time_frame>At 3 months after the baseline visit</time_frame>
    <description>Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups.&#xD;
DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups</measure>
    <time_frame>At 6 months after the baseline visit</time_frame>
    <description>Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups.&#xD;
DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups</measure>
    <time_frame>At 12 months after the baseline visit</time_frame>
    <description>Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups.&#xD;
DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Euglyca</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the Euglyca group were advised to download the Euglyca application on their smartphones and they were asked to use the application for the calculation of the bolus insulin dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Euglyca application</intervention_name>
    <description>'Euglyca' is a mobile application developed by two of the authors (CC and DF). The application has a data base of 7000 foods and food products met in greek eating habits as well as the corresponding amount of carbohydrates and lipids for each of them. Subsequently, the amount of carbohydrates and lipids contained in a meal are calculated automatically by the application. By taking into consideration the amount of carbohydrates and lipids to be consumed, the preprandial and target post-prandial glycemia concentrations, the insulin correction factor for the patient, the carbohydrates and lipids factors and the active insulin (in case of CSII), 'Euglyca' calculates the required bolus dose of insulin.</description>
    <arm_group_label>Euglyca</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents with Diabetes Mellitus type 1.&#xD;
&#xD;
          -  Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin&#xD;
             infusion (CSII)&#xD;
&#xD;
          -  Satisfactory knowledge of the concept of carbohydrates and lipids counting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of another medical application for diabetes in the previous 3 months;&#xD;
&#xD;
          -  Lack of capacity of reading greek.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endocrine Unit of 3rd Department of Pediatrics of Aristotle University of Thessaloniki, Hippokration General Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54642</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Christos Chatzakis</investigator_full_name>
    <investigator_title>Christos Chatzakis MD, MSc</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <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>Undecided</sharing_ipd>
    <ipd_description>Undecided yet</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03763474/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03763474
org study id: Euglyca application
nct id: NCT03763474
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
80 children and adolescents with Diabetes Mellitus Type 1 were enrolled in the study and were
      randomly assigned in the intervention group (Euglyca group) or in the control group. Patients
      in the Euglyca group were asked to use the application in order to calculate the bolus
      insulin dose. Primary outcomes of the study were the Glycosylated hemoglobin, percentage of
      normoglycemias and the Diabetes Treatment Satisfaction Questionnaire Score. Patients were
      evaluated at the baseline, 3, 6 and 12 months after the beginning of the study.
Children and adolescents with Diabetes Mellitus Type 1 (T1DM) who visited consecutively this
      clinic were asked to participate in the study if they owned an Android smartphone and were
      familiar with its use. Patients were included after one of their parents or their legal
      guardian signed an informed consent. Inclusion criteria were: 1. Treatment with multiple
      daily injections (MDI) or continuous subcutaneous insulin infusion (CSII); 2. satisfactory
      knowledge of the concept of carbohydrates and lipids counting acquired following previous
      training by the physicians and nutritionist of the department at initial diagnosis and
      thereafter during follow-up visits. Exclusion criteria were: 1. Use of another medical
      application for diabetes in the previous 3 months; 2. lack of capacity of reading greek.

      80 patients met the inclusion criteria and agreed to participate in the study. Subsequently
      they were randomized to two equally numbered groups by drawing one of two nontransparent
      envelopes which contained one ticket inscribed with either a E (for Euglyca group) or a C
      (for Control group). To ensure equal allocation rates within the 2 groups, block
      randomization was employed.

      At the initial visit, patients randomized to the E group were advised to download the Euglyca
      application on their smartphones and they were asked to use the application for the
      calculation of the bolus insulin dose they were injected. Patients randomized to the C group
      were advised to calculate bolus insulin dose they were injected, the way they used to do.
      Patients repeated their visit to the endocrine pediatric clinic at 3, 6 and 12 months, the
      latter set as the terminal time-point of this study following the initial visit. At all 4
      visits, anthropometrics (weight, height, BMI), blood pressure measurement and heart rate were
      noted down, while a peripheral blood sample was drawn from all patients in the morning of
      each visit after an overnight fast for measurement of glycemia and glycosylated hemoglobin
      (HbA1c) levels. Glucose measurements between 70 and 180 mg/dl were categorized as
      normoglycemia; any glucose measurement below 70mg/dl was categorized as hypoglycemia; glucose
      measurements at two hours postprandial measurement found above 180mg/dl were categorized as
      hyperglycemia. At baseline (first visit), at 6 months (third visit) and at terminal
      time-point (12 months) all patients filled the World Health Organization-Standard DTSQ.
      Patients' logbooks and readings from their glucose meters were reviewed by the physicians and
      nutritionist of the department at each of the four visits and the percentage of
      normoglycemic, hypoglycemic and hyperglycemic episodes during the preceding trimester was
      calculated for each patient. The change of HbA1c values from baseline to the terminal
      time-point for each group was set as primary outcome, while the percentage of normoglycemic,
      hypoglycemic and hyperglycemic events over the total number of glucose measurements during
      the preceding trimester of each visit was set as secondary outcome.

      Glycosylated hemoglobin was determined by Siemens DCA Vantage point-of-care immunoassay
      analyzer (Siemens Health care Diagnostics Ltd., Frimley, Camberley, UK) with intra- and
      inter- assay coefficients of variation (CV) 5% and 8%, respectively; glycemia was determined
      by glucose god/pap kit with intra- and inter- assay CVs 5.7% and 7.8%, respectively.

      'Euglyca' is a mobile application that we developed . The application has a data base of 7000
      foods and food products met in greek eating habits as well as the corresponding amount of
      carbohydrates and lipids for each of them. Subsequently, the amount of carbohydrates and
      lipids contained in a meal are calculated automatically by the application. By taking into
      consideration the amount of carbohydrates and lipids to be consumed, the preprandial and
      target post-prandial glycemia concentrations, the insulin correction factor for the patient,
      the carbohydrates and lipids factors and the active insulin (in case of CSII), 'Euglyca'
      calculates the required bolus dose of insulin.

      Sample size was determined by estimating the change in HbA1c values (primary outcome) based
      on previous studies (7, 8), assuming 0.5% reduction in HbA1c in the intervention group with
      80% power and 5% significance level. Power calculation resulted in 14 patients per group,
      while the target of the study had been set at recruitment of 80 patients altogether. Results
      are reported as mean ± standard deviation (SD) for quantitative variables. The absolute
      difference in a quantitative variable between two different time points was defined as Δ. All
      quantitative variables (HbA1c; ΔHbA1c; percentages of normoglycemic, hypoglycemic and
      hyperglycemic events over a total number of glucose measurements; DTSQ's scores) were
      normally distributed and they were compared between the two studied groups of patients at the
      different time-points by employing General Linear Models ANOVA and Bonferroni post-hoc test.
      Repeated measures ANOVA involved one factor between patients (factor "Group" with two levels)
      and one factor for the repeated measures within patients (factor "time" with 4 or 3 levels
      depending on the compared variable). Qualitative variables (gender and type of therapy) were
      compared by employing x2 (chi square) test after having computed absolute and relative
      frequencies (percentages %), Statistical significance was set at P<0,05. An intention to
      treat analysis was followed. IBM SPSS V23 Chicago, USA software was used for the statistical
      analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Outcomes assessors were blinded as for the allocation of the patients in the 2 groups.
measure: Level of glycosylated hemoglobin in the 2 groups
time frame: At 3 months after the baseline visit
description: Comparison of the level of glycosylated hemoglobin between the 2 groups
measure: Level of glycosylated hemoglobin in the 2 groups
time frame: At 6 months after the baseline visit
description: Comparison of the level of glycosylated hemoglobin between the 2 groups
measure: Level of glycosylated hemoglobin in the 2 groups
time frame: At 12 months after the baseline visit
description: Comparison of the level of glycosylated hemoglobin between the 2 groups
measure: Change from Baseline glycosylated hemoglobin at 3 months in the 2 groups
time frame: At 3 months after the baseline visit
description: Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups
measure: Change from 3 months glycosylated hemoglobin at 6 months in the 2 groups
time frame: At 6 months after the baseline visit
description: Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups
measure: Change from 6 months glycosylated hemoglobin at 12 months in the 2 groups
time frame: At 12 months after the baseline visit
description: Comparison of the differences in the level of glycosylated hemoglobin between the 2 groups
measure: Percentage of Normoglycemias in the 2 groups
time frame: At 3 months after the baseline visit
description: Comparison of the percentage of Normoglycemias between the 2 groups
measure: Percentage of Normoglycemias in the 2 groups
time frame: At 6 months after the baseline visit
description: Comparison of the percentage of Normoglycemias between the 2 groups
measure: Percentage of Normoglycemias in the 2 groups
time frame: At 12 months after the baseline visit
description: Comparison of the percentage of Normoglycemias between the 2 groups
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups
time frame: At 3 months after the baseline visit
description: Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups.
DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated.
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups
time frame: At 6 months after the baseline visit
description: Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups.
DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated.
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) score in the 2 groups
time frame: At 12 months after the baseline visit
description: Comparison of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score between the 2 groups.
DTSQ consists of 8 elements. Each element can be graded in a scale from 0 to 6. Two of the elements concern the perceived hypoglycemia or hyperglycemia. By adding the grades of each of the rest 6 elements the DTSQ score is calculated.
arm group label: Euglyca
arm group type: Experimental
description: Patients randomized to the Euglyca group were advised to download the Euglyca application on their smartphones and they were asked to use the application for the calculation of the bolus insulin dose.
arm group label: Control
arm group type: No Intervention
intervention type: Combination Product
intervention name: Euglyca application
description: 'Euglyca' is a mobile application developed by two of the authors (CC and DF). The application has a data base of 7000 foods and food products met in greek eating habits as well as the corresponding amount of carbohydrates and lipids for each of them. Subsequently, the amount of carbohydrates and lipids contained in a meal are calculated automatically by the application. By taking into consideration the amount of carbohydrates and lipids to be consumed, the preprandial and target post-prandial glycemia concentrations, the insulin correction factor for the patient, the carbohydrates and lipids factors and the active insulin (in case of CSII), 'Euglyca' calculates the required bolus dose of insulin.
arm group label: Euglyca
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Christos Chatzakis
investigator title: Christos Chatzakis MD, MSc
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Undecided
ipd description: Undecided yet
provided document: 