<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/NCT03258268</url>
  </required_header>
  <id_info>
    <org_study_id>EASY-1</org_study_id>
    <nct_id>NCT03258268</nct_id>
  </id_info>
  <brief_title>Easy Diabetes Treatment Study 1</brief_title>
  <acronym>EASY-1</acronym>
  <official_title>A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Läkarexpressen AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region Halland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Västra Götalandsregionen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Läkarexpressen AB</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic&#xD;
      outcomes of individualized treatment support in patients with type 2 diabetes. The primary&#xD;
      objective of the trial is to confirm the superiority of standard of care with EASY DSS versus&#xD;
      standard of care without EASY DSS in terms of glycemic control in patients with type 2&#xD;
      diabetes with ongoing treatment with any antidiabetic drug(s).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</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>
    <intervention_model_description>Multicenter, randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>26 weeks</time_frame>
    <description>Change from baseline HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>26 weeks</time_frame>
    <description>Change from baseline in fasting plasma glucose (FPG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achieving treatment target</measure>
    <time_frame>26 weeks</time_frame>
    <description>Meeting treatment target of HbA1c &lt; 7% (53 mmol/mol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia</measure>
    <time_frame>26 weeks</time_frame>
    <description>Meeting treatment target of HbA1c &lt; 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Standard of Care with DSS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive standard of care with a board certified physician with EASY DSS.&#xD;
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care without DSS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive standard of care with a board certified physician without EASY DSS.&#xD;
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard of Care with EASY DSS</intervention_name>
    <description>The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients.&#xD;
Patients will receive standard of care with a board certified physician with EASY DSS.&#xD;
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.</description>
    <arm_group_label>Standard of Care with DSS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care without EASY DSS</intervention_name>
    <description>Patients will receive standard of care with a board certified physician without EASY DSS.&#xD;
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.</description>
    <arm_group_label>Standard of Care without DSS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities. Trial-related&#xD;
             activities are any procedures that are carried out as part of the trial, including&#xD;
             activities to determine suitability for the trial&#xD;
&#xD;
          -  ≥ 18 years of age at the time of signing informed consent&#xD;
&#xD;
          -  Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening&#xD;
&#xD;
          -  HbA1c ≥ 7.0 [58 mmol/mol] by central laboratory analysis&#xD;
&#xD;
          -  Stable daily treatment with any single antidiabetic drug or any combination of&#xD;
             antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of&#xD;
             insulin dose and temporary dose correction because of e.g. infection are allowed)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in this trial. Participation is defined as informed consent.&#xD;
&#xD;
          -  Currently participating in other clinical trials for diabetes&#xD;
&#xD;
          -  Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated&#xD;
             autoantibodies&#xD;
&#xD;
          -  History of diabetic ketoacidosis or hyperosmolar hyperglycemic state&#xD;
&#xD;
          -  Corticosteroid-induced or pancreatitis-induced diabetes&#xD;
&#xD;
          -  History of chronic or acute pancreatitis&#xD;
&#xD;
          -  Known or suspected substance abuse&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Anticipated change in concomitant medication, which, in the opinion of the&#xD;
             investigator, could interfere with the glucose metabolism (e.g. systemic&#xD;
             corticosteroids or statins)&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure &gt; 180 mmHg and/or diastolic blood&#xD;
             pressure &gt; 100 mmHg)&#xD;
&#xD;
          -  Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate &lt; 15&#xD;
             mL/min/1.73m2&#xD;
&#xD;
          -  Recent or planned major surgery (such as gastric bypass operation)&#xD;
&#xD;
          -  Major psychiatric disorders, mental incapacity, unwillingness or language barrier&#xD;
             precluding adequate understanding of the trial procedure or cooperation with the trial&#xD;
             site personnel&#xD;
&#xD;
          -  Life-threatening disease including malignant neoplasms and medical history of&#xD;
             malignant neoplasms within the last 5 years (except basal and squamous cell skin&#xD;
             cancer)&#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>Damon Tojjar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Region Halland</name>
      <address>
        <city>Halland</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Region Skåne</name>
      <address>
        <city>Skåne</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Västra Götalandsregionen</name>
      <address>
        <city>Västra Götaland</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</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 2</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/NCT03258268
org study id: EASY-1
nct id: NCT03258268
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic
      outcomes of individualized treatment support in patients with type 2 diabetes. The primary
      objective of the trial is to confirm the superiority of standard of care with EASY DSS versus
      standard of care without EASY DSS in terms of glycemic control in patients with type 2
      diabetes with ongoing treatment with any antidiabetic drug(s).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.
measure: HbA1c
time frame: 26 weeks
description: Change from baseline HbA1c
measure: Fasting plasma glucose
time frame: 26 weeks
description: Change from baseline in fasting plasma glucose (FPG)
measure: Achieving treatment target
time frame: 26 weeks
description: Meeting treatment target of HbA1c < 7% (53 mmol/mol)
measure: Hypoglycemia
time frame: 26 weeks
description: Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes
arm group label: Standard of Care with DSS
arm group type: Experimental
description: Patients will receive standard of care with a board certified physician with EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
arm group label: Standard of Care without DSS
arm group type: Active Comparator
description: Patients will receive standard of care with a board certified physician without EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
intervention type: Device
intervention name: Standard of Care with EASY DSS
description: The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients.
Patients will receive standard of care with a board certified physician with EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
arm group label: Standard of Care with DSS
intervention type: Other
intervention name: Standard of Care without EASY DSS
description: Patients will receive standard of care with a board certified physician without EASY DSS.
The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
arm group label: Standard of Care without DSS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Damon Tojjar, MD
role: Principal Investigator
affiliation: Lund University
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No