<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/NCT01677546</url>
  </required_header>
  <id_info>
    <org_study_id>Bolus-calculator</org_study_id>
    <nct_id>NCT01677546</nct_id>
  </id_info>
  <brief_title>Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).</brief_title>
  <official_title>The Impact of Insulin Pump Bolus Calculator and Wireless Communication With Blood Glucose Meter on Metabolic Control in Children With Type 1 Diabetes Mellitus - Randomised Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models.&#xD;
      Together with wireless communication with blood glucose meter potentially facilitates&#xD;
      achieving the target post prandial glucose levels. In this RCT authors assessed whether use&#xD;
      of wireless communication between compatible devices: MiniMed insulin pump and blood glucose&#xD;
      meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is&#xD;
      the impact of exerting this tool on metabolic control in type 1 diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using&#xD;
      insulin pump bolus calculator wirelessly connected with blood glucose meter, group B-&#xD;
      subjects using insulin pump bolus calculator without wireless communication with blood&#xD;
      glucose meter or group C- insulin pump, without bolus calculator function. We compared the&#xD;
      glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation&#xD;
      between the groups. We also assessed secondary endpoints (mentioned above).&#xD;
&#xD;
      Patients were estimated at three time points: at the beginning, after 6 weeks and after 3&#xD;
      months of intervention. Investigators performed computer reports at each visit, with&#xD;
      Medtronic CareLink Pro software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c (Glycated hemoglobin)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post- prandial glycaemia</measure>
    <time_frame>2 hours after the meals</time_frame>
    <description>Post- prandial glycaemia is express as a mean post- prandial glycaemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>Simple questions regarded treatment satisfaction and wish to continuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycaemia episodes and severe hypoglycaemia events</measure>
    <time_frame>3 months</time_frame>
    <description>Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of self- blood glucose monitoring</measure>
    <time_frame>3 months</time_frame>
    <description>Number of self- blood glucose monitoring per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperglycaemic episodes</measure>
    <time_frame>3 months</time_frame>
    <description>Hyperglycaemia defined as glycaemia above 180 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of meal boluses</measure>
    <time_frame>3 months</time_frame>
    <description>Number of meal boluses per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of bolus calculator using</measure>
    <time_frame>3 months</time_frame>
    <description>Number of bolus calculator use per day</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total daily dose of insulin</measure>
    <time_frame>3 months</time_frame>
    <description>Total daily dose of insulin express as jm/kg/d</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index- standard deviation (BMI- sds)</measure>
    <time_frame>3 months</time_frame>
    <description>Body mass index- sds</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>CSII+BC+CL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSII+BC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSII (insulin pump only)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients using insulin pump (CSII) without BC and connection with CL</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CSII+BC+CL</intervention_name>
    <description>Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)</description>
    <arm_group_label>CSII+BC+CL</arm_group_label>
    <other_name>Insulin pump, bolus calculator, bolus Wizard, Contour Link</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CSII+BC</intervention_name>
    <description>Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)</description>
    <arm_group_label>CSII+BC</arm_group_label>
    <other_name>Insulin pump, bolus calculator, bolus Wizard</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  7- 18 years old&#xD;
&#xD;
          -  type 1 diabetes mellitus for over 1 year&#xD;
&#xD;
          -  treatment with insulin pump with bolus calculator function&#xD;
&#xD;
          -  HbA1c &lt; 10%&#xD;
&#xD;
          -  expressed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recall the consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Agnieszka Szypowska, A. Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>insulin pump</keyword>
  <keyword>bolus calculator</keyword>
  <keyword>Contour Link</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>
  <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>
  <!-- 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/NCT01677546
org study id: Bolus-calculator
nct id: NCT01677546
lead sponsor: 
has dmc: No
Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models.
      Together with wireless communication with blood glucose meter potentially facilitates
      achieving the target post prandial glucose levels. In this RCT authors assessed whether use
      of wireless communication between compatible devices: MiniMed insulin pump and blood glucose
      meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is
      the impact of exerting this tool on metabolic control in type 1 diabetic patients.
In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using
      insulin pump bolus calculator wirelessly connected with blood glucose meter, group B-
      subjects using insulin pump bolus calculator without wireless communication with blood
      glucose meter or group C- insulin pump, without bolus calculator function. We compared the
      glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation
      between the groups. We also assessed secondary endpoints (mentioned above).

      Patients were estimated at three time points: at the beginning, after 6 weeks and after 3
      months of intervention. Investigators performed computer reports at each visit, with
      Medtronic CareLink Pro software.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: HbA1c (Glycated hemoglobin)
time frame: 3 months
measure: Post- prandial glycaemia
time frame: 2 hours after the meals
description: Post- prandial glycaemia is express as a mean post- prandial glycaemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
measure: Treatment satisfaction
time frame: 3 months
description: Simple questions regarded treatment satisfaction and wish to continuation.
measure: Hypoglycaemia episodes and severe hypoglycaemia events
time frame: 3 months
description: Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.
measure: Frequency of self- blood glucose monitoring
time frame: 3 months
description: Number of self- blood glucose monitoring per day
measure: Hyperglycaemic episodes
time frame: 3 months
description: Hyperglycaemia defined as glycaemia above 180 mg/dl
measure: Frequency of meal boluses
time frame: 3 months
description: Number of meal boluses per day
measure: Frequency of bolus calculator using
time frame: 3 months
description: Number of bolus calculator use per day
measure: Total daily dose of insulin
time frame: 3 months
description: Total daily dose of insulin express as jm/kg/d
measure: Body mass index- standard deviation (BMI- sds)
time frame: 3 months
description: Body mass index- sds
arm group label: CSII+BC+CL
arm group type: Experimental
description: Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL)
arm group label: CSII+BC
arm group type: Experimental
description: Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL)
arm group label: CSII (insulin pump only)
arm group type: No Intervention
description: Patients using insulin pump (CSII) without BC and connection with CL
intervention type: Device
intervention name: CSII+BC+CL
description: Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
arm group label: CSII+BC+CL
other name: Insulin pump, bolus calculator, bolus Wizard, Contour Link
intervention type: Device
intervention name: CSII+BC
description: Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)
arm group label: CSII+BC
other name: Insulin pump, bolus calculator, bolus Wizard
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
last name: Agnieszka Szypowska, A. Professor
role: Study Chair
affiliation: Medical University of Warsaw
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc