<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/NCT03003806</url>
  </required_header>
  <id_info>
    <org_study_id>RMC072016ctil</org_study_id>
    <nct_id>NCT03003806</nct_id>
  </id_info>
  <brief_title>Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study</brief_title>
  <acronym>Advice4U</acronym>
  <official_title>Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- Open Label, Parallel , Randomized, Controlled Multicenter Study-The Advice4U Pro Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DreaMed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rabin Medical Center</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>
      The DreaMed Advisor Pro is a software which automatically analyses treatment information,&#xD;
      learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed&#xD;
      Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary&#xD;
      blood glucose measurements), insulin dosing and meal data during daily routine home care.&#xD;
      Following a 5-minute data collection and analysis, the algorithm learns and suggests&#xD;
      pump-setting changes for optimization of glucose control&#xD;
&#xD;
      The algorithm is designed as an advisory tool and has three main components:&#xD;
&#xD;
        1. A statistical analysis of the insulin pump and sensor data: insulin delivery,&#xD;
           bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia&#xD;
           patterns.&#xD;
&#xD;
        2. Practical recommendations, alert messages based on aforementioned data&#xD;
&#xD;
        3. Recommendation for new insulin pump settings: including basal intervals and rate,&#xD;
           different carbohydrate ratio according to time of day, correction factor and insulin&#xD;
           sensitivity time.&#xD;
&#xD;
      The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with&#xD;
      Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump&#xD;
      users.&#xD;
&#xD;
      The main objective of the proposed study is to evaluate the safety and efficacy of using the&#xD;
      DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin&#xD;
      dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">November 10, 2019</completion_date>
  <primary_completion_date type="Actual">November 10, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings below 50 mg/dl (2.8 mmol/L)</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings above 180 mg/dl (10.0 mmol/L)</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings above 240 mg/dl (13.3 mmol/L)</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area above the curve of glucose glucose level of 180 mg/dl</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose level of 70 mg/dl</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean sensor blood glucose</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose variability measured by Standard Deviation</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recommendations for changes in settings per patient</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recommendations for changes in settings per iteration</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of physician override Advisor recommendations</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients overrides of recommendation</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated time duration needed for the physician to give its recommendations</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device satisfaction questionaire</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes treatment satisfaction questionnaire</measure>
    <time_frame>Final visit (week 31)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Type1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>DreaMed Advisor Pro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group-medical guided recommendations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DreaMed Advisor Pro</intervention_name>
    <description>Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro</description>
    <arm_group_label>DreaMed Advisor Pro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical guided recommendation</intervention_name>
    <description>Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team</description>
    <arm_group_label>Control group-medical guided recommendations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with Type 1 diabetes (&gt;1yr since diagnosis)&#xD;
&#xD;
          -  Age ≥ 10 years up to 21 years&#xD;
&#xD;
          -  HbA1c at inclusion ≥ 7.0% and ≤ 10%&#xD;
&#xD;
          -  Insulin infusion pump therapy: &quot;OmniPod®&quot; Insulin pump (insulet Corp., Bedford, &quot;MA&quot;,&#xD;
             USA) or any Medtronic pump that is comparable with Glooko app for at least 4 months&#xD;
&#xD;
          -  BMI Standard Deviation Score (SDS) - below the 97th percentile for age&#xD;
&#xD;
          -  Patients willing to follow study instructions (at least 2 capillary blood glucose&#xD;
             readings/day, use the bolus-calculator feature of the pump)&#xD;
&#xD;
          -  Patient/ parents are required to have minimum computer skills and understanding of&#xD;
             navigating the internet&#xD;
&#xD;
          -  Patients willing to use dexcom sensor for the study duration&#xD;
&#xD;
          -  Patients/ parents will have to have a smart phone (Apple, Android, Windows)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An episode of diabetic ketoacidosis within the month prior to study entry&#xD;
&#xD;
          -  Concomitant diseases/ treatment that influence metabolic control&#xD;
&#xD;
          -  Any significant diseases /conditions including psychiatric disorders and substance&#xD;
             abuse that in the opinion of the investigator is likely to affect the subject's&#xD;
             ability to complete the study or compromise patient's safety,&#xD;
&#xD;
          -  Participation in any other interventional study&#xD;
&#xD;
          -  Known or suspected allergy to trial products such as adhesives, tapes, needles. An&#xD;
             allergy to contrast medium, use of other active medical devices (such as pacemaker,&#xD;
             ICD) and planned imaging examinations (such as MRI).&#xD;
&#xD;
          -  Female subject who is pregnant or lactating planning to become pregnant within the&#xD;
             planned study duration -Severe hypoglycemia six month prior to enrollment as defined&#xD;
             by the American Diabetes Association (ADA) and Endocrine Society as follows: &quot;Severe&#xD;
             hypoglycemia is an event requiring assistance of another person to actively administer&#xD;
             carbohydrates, glucagon, or take other corrective actions&quot;. -&#xD;
&#xD;
          -  Current use of the following medications: medications that are used to lower blood&#xD;
             glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers,&#xD;
             glucocorticoids and other medications, which in the judgment of the investigator would&#xD;
             be a contraindication to participation in the study (Anticoagulant therapy e.g.&#xD;
             Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)&#xD;
&#xD;
          -  Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic&#xD;
             foot syndrome) or any secondary disease or complication of diabetes mellitus&#xD;
&#xD;
               -  Subject has unstable or rapidly progressive renal disease or is receiving&#xD;
                  dialysis&#xD;
&#xD;
               -  Subject has active proliferating retinopathy&#xD;
&#xD;
               -  Active gastroparesis&#xD;
&#xD;
          -  Patient suffers from an eating disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Barbara Davis Center for Childhood Diabetes</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045-6511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520-8064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center, One Joslin Place</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes -Zentrum fuer kinder und jugendliche</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schnider children's medical center</name>
      <address>
        <city>Petach-Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Israel</country>
    <country>Slovenia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 26, 2019</last_update_submitted>
  <last_update_submitted_qc>December 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insulin pump treatment</keyword>
  <keyword>Type 1 diabetes</keyword>
  <keyword>Pump setting advisor</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>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/NCT03003806
org study id: RMC072016ctil
nct id: NCT03003806
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The DreaMed Advisor Pro is a software which automatically analyses treatment information,
      learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed
      Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary
      blood glucose measurements), insulin dosing and meal data during daily routine home care.
      Following a 5-minute data collection and analysis, the algorithm learns and suggests
      pump-setting changes for optimization of glucose control

      The algorithm is designed as an advisory tool and has three main components:

        1. A statistical analysis of the insulin pump and sensor data: insulin delivery,
           bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia
           patterns.

        2. Practical recommendations, alert messages based on aforementioned data

        3. Recommendation for new insulin pump settings: including basal intervals and rate,
           different carbohydrate ratio according to time of day, correction factor and insulin
           sensitivity time.

      The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with
      Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump
      users.

      The main objective of the proposed study is to evaluate the safety and efficacy of using the
      DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin
      dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).
time frame: Final visit (week 31)
measure: Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)
time frame: Final visit (week 31)
measure: HbA1c
time frame: Final visit (week 31)
measure: Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
time frame: Final visit (week 31)
measure: Percentage of readings below 50 mg/dl (2.8 mmol/L)
time frame: Final visit (week 31)
measure: Percentage of readings above 180 mg/dl (10.0 mmol/L)
time frame: Final visit (week 31)
measure: Percentage of readings above 240 mg/dl (13.3 mmol/L)
time frame: Final visit (week 31)
measure: Area above the curve of glucose glucose level of 180 mg/dl
time frame: Final visit (week 31)
measure: Area under the curve of glucose level of 70 mg/dl
time frame: Final visit (week 31)
measure: Mean sensor blood glucose
time frame: Final visit (week 31)
measure: Glucose variability measured by Standard Deviation
time frame: Final visit (week 31)
measure: Number of recommendations for changes in settings per patient
time frame: Final visit (week 31)
measure: Number of recommendations for changes in settings per iteration
time frame: Final visit (week 31)
measure: Number of physician override Advisor recommendations
time frame: Final visit (week 31)
measure: Number of patients overrides of recommendation
time frame: Final visit (week 31)
measure: Estimated time duration needed for the physician to give its recommendations
time frame: Final visit (week 31)
measure: Device satisfaction questionaire
time frame: Final visit (week 31)
measure: Diabetes treatment satisfaction questionnaire
time frame: Final visit (week 31)
arm group label: DreaMed Advisor Pro
arm group type: Experimental
description: Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
arm group label: Control group-medical guided recommendations
arm group type: Active Comparator
description: Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
intervention type: Device
intervention name: DreaMed Advisor Pro
description: Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
arm group label: DreaMed Advisor Pro
intervention type: Other
intervention name: Medical guided recommendation
description: Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
arm group label: Control group-medical guided recommendations
criteria: 
gender: All
minimum age: 10 Years
maximum age: 21 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Israel
country: Slovenia
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No