<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/NCT01715090</url>
  </required_header>
  <id_info>
    <org_study_id>NL 40248.018.12</org_study_id>
    <nct_id>NCT01715090</nct_id>
  </id_info>
  <brief_title>Web-based Insulin Titration - An Efficacy Study</brief_title>
  <official_title>Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to determine whether an intensive web-based titration&#xD;
      system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective&#xD;
      in improving glycaemic control in patients with diabetes mellitus type 2 using a basal&#xD;
      insulin, compared to standard care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in HbA1c</measure>
    <time_frame>Change from baseline after 13 weeks and after 26 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life and treatment satisfaction</measure>
    <time_frame>Change from baseline after 13 weeks and after 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total contact time with study staff (and the PANDIT system, if applicable)</measure>
    <time_frame>After 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who reach the target of HbA1c &lt; 7.0%</measure>
    <time_frame>After 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in fasting plasma glucose</measure>
    <time_frame>Change from baseline after 13 weeks and after 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)</measure>
    <time_frame>After 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the usage of PANDIT among patients</measure>
    <time_frame>After 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of important factors for patient compliance to internet-based self-care interventions</measure>
    <time_frame>After 26 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Web-based insulin titration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An online web-based insulin titration algorithm to guide patients in self-titration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Web-based insulin titration</intervention_name>
    <arm_group_label>Web-based insulin titration</arm_group_label>
    <other_name>PANDIT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 18 and 80 years&#xD;
&#xD;
          -  Type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months&#xD;
&#xD;
          -  Once daily basal insulin therapy usage&#xD;
&#xD;
          -  No restriction on HbA1c or FPG&#xD;
&#xD;
          -  BMI &lt; 40 kg/m2&#xD;
&#xD;
          -  Ability to read and understand the Dutch language&#xD;
&#xD;
          -  Familiarity with the Internet and use of a mobile phone&#xD;
&#xD;
          -  Ability and willingness to adhere to the protocol&#xD;
&#xD;
          -  Ability and willingness to use a web-based insulin self-titration system&#xD;
&#xD;
          -  Confirmed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Use of systemic corticosteroid in the last three months&#xD;
&#xD;
          -  Recurrent severe hypoglycaemia or hypoglycaemic unawareness&#xD;
&#xD;
          -  Active proliferative diabetic retinopathy&#xD;
&#xD;
          -  Any clinically significant disease or disorder&#xD;
&#xD;
          -  Mental condition rendering the patient unable to understand the nature, scope and&#xD;
             possible consequences of the study&#xD;
&#xD;
          -  Working in night shifts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frits Holleman, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Simon AC, Holleman F, Hoekstra JB, De Clercq PA, Lemkes BA, Hermanides J, Peek N. Development of a web-based decision support system for insulin self-titration. Stud Health Technol Inform. 2011;169:103-7.</citation>
    <PMID>21893723</PMID>
  </results_reference>
  <results_reference>
    <citation>Simon AC, Holleman F, Gude WT, Hoekstra JB, Peek N. Safety of a web-based insulin titration system for patients with type 2 diabetes mellitus - pilot study. Stud Health Technol Inform. 2012;180:731-5.</citation>
    <PMID>22874288</PMID>
  </results_reference>
  <results_reference>
    <citation>Gude WT, Simon AC, Peute LW, Holleman F, Hoekstra JB, Peek N, Jaspers MW. Formative usability evaluation of a web-based insulin self-titration system: preliminary results. Stud Health Technol Inform. 2012;180:1209-11.</citation>
    <PMID>22874403</PMID>
  </results_reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>F Holleman</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</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/NCT01715090
org study id: NL 40248.018.12
nct id: NCT01715090
lead sponsor: 
has dmc: No
The main objective of the study is to determine whether an intensive web-based titration
      system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective
      in improving glycaemic control in patients with diabetes mellitus type 2 using a basal
      insulin, compared to standard care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change in HbA1c
time frame: Change from baseline after 13 weeks and after 26 weeks
measure: Quality of life and treatment satisfaction
time frame: Change from baseline after 13 weeks and after 26 weeks
measure: Total contact time with study staff (and the PANDIT system, if applicable)
time frame: After 26 weeks
measure: Proportion of subjects who reach the target of HbA1c < 7.0%
time frame: After 26 weeks
measure: Mean change in fasting plasma glucose
time frame: Change from baseline after 13 weeks and after 26 weeks
measure: Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)
time frame: After 26 weeks
measure: Frequency of the usage of PANDIT among patients
time frame: After 26 weeks
measure: Detection of important factors for patient compliance to internet-based self-care interventions
time frame: After 26 weeks
arm group label: Web-based insulin titration
arm group type: Experimental
description: An online web-based insulin titration algorithm to guide patients in self-titration
arm group label: Standard care
arm group type: No Intervention
intervention type: Device
intervention name: Web-based insulin titration
arm group label: Web-based insulin titration
other name: PANDIT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Frits Holleman, MD PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
facility: 
country: Netherlands
citation: Simon AC, Holleman F, Hoekstra JB, De Clercq PA, Lemkes BA, Hermanides J, Peek N. Development of a web-based decision support system for insulin self-titration. Stud Health Technol Inform. 2011;169:103-7.
PMID: 21893723
citation: Simon AC, Holleman F, Gude WT, Hoekstra JB, Peek N. Safety of a web-based insulin titration system for patients with type 2 diabetes mellitus - pilot study. Stud Health Technol Inform. 2012;180:731-5.
PMID: 22874288
citation: Gude WT, Simon AC, Peute LW, Holleman F, Hoekstra JB, Peek N, Jaspers MW. Formative usability evaluation of a web-based insulin self-titration system: preliminary results. Stud Health Technol Inform. 2012;180:1209-11.
PMID: 22874403
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: F Holleman
investigator title: MD PhD
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin