<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/NCT03774069</url>
  </required_header>
  <id_info>
    <org_study_id>RMC040818ctil</org_study_id>
    <nct_id>NCT03774069</nct_id>
  </id_info>
  <brief_title>The Advisor Pro Direct Study</brief_title>
  <official_title>Evaluation of Remote Consultation to Patients With Type 1 Diabetes Under Continuous Glucose Sensors and Insulin Pump Therapy Using the DreaMed Advisor Pro. An Open Label, Randomized Non-inferiority Study of Insulin Pump Therapy Adjustments Between DreaMed Advisor Pro and Standard of Care-The Advisor Pro Direct 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>
  </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. DreaMed&#xD;
      Advisor Pro is a decision- support software intended for assisting healthcare professionals&#xD;
      in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery&#xD;
      therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or&#xD;
      CGM and self-management blood glucose meter.&#xD;
&#xD;
      The main objective of the proposed study is to test the safety, reliability, and efficacy of&#xD;
      the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient&#xD;
      without a physician review.&#xD;
&#xD;
      Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed&#xD;
      Advisor Pro) or control group (standard of care). Participants will download the CGM and pump&#xD;
      data at no less frequent than every 4 weeks for both groups during the 3 months period of the&#xD;
      study.&#xD;
&#xD;
      Each time new data is received, the following actions will be performed:&#xD;
&#xD;
      In the intervention group, a new algorithm recommendation for pump settings will be issued.&#xD;
      The recommendation will be approved by a technical, non-physician to assure that glucose data&#xD;
      are not fall within predefined safety criteria which require a physician approval before the&#xD;
      recommendation will be sent to the patient, otherwise, recommendation will be sent directly&#xD;
      to the patient.&#xD;
&#xD;
      In the control group, if no safety criteria is met, it is the responsibility of the patient&#xD;
      to contact his/her physician to advise on change of treatment. In case a safety issue has&#xD;
      occurred, the physician will contact the patient and change the pump settings.&#xD;
&#xD;
      Prior to initiating the interventional phase of the study, we will evaluate the experience of&#xD;
      patients in self adjustments of insulin dosing in regular care management and to evaluate&#xD;
      their acceptance for using an automated dosing recommendations software. The evaluation will&#xD;
      be done by asking patients/caregivers to fill 15 questions survey. 100 patients are&#xD;
      anticipated to participate in this phase of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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 10mmol/L)</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of readings below 54 mg/dl (3.3 mmol/l)</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes treatment satisfaction questionnaire</measure>
    <time_frame>Final visit (week 12)</time_frame>
    <description>The questionnaire contains 12-14 items (12 for the teens version and 14 for the parents version) the subscale for each items is from 0 to 6, and for most items the the higher the score, the greater the satisfaction with the treatment.Subscales are summed. More specific instruction for analysis are detailed in Diabetologia 52:(suppl 1) S397, Abstruct 1013 and in a document named &quot;Summary of recommended scoring&quot; by Prof. Bradley, University of London</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings below 60 mg/dl (3.35mmol/L)</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings above 180 mg/dl (10.0mmol/L)</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of readings above 250 mg/dl (13.9 mmol/L)</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area above the curve of glucose level of 180 mg/dl</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area above the curve of glucose level above180 mg/dl</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose level of 70 mg/dl</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose level below 70 mg/dl</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean sensor blood glucose</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose variability measured by standard deviation</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recommendations for changes in settings per patient</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recommendations for changes in settings per iteration</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of physician override Advisor recommendation</measure>
    <time_frame>Final visit (week 12)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Type 1 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 recommendation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration 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 and sent directly to the patient</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 according to standard of care</description>
    <arm_group_label>Control group- medical guided recommendation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with type 1 diabetes (&gt;1 yr diagnosis)&#xD;
&#xD;
          2. Age- 6-30 years old&#xD;
&#xD;
          3. HbA1c equals or above 7% and equals or below 10%&#xD;
&#xD;
          4. Insulin infusion pump CSII (Continuous Subcutaneous Inulin Infusion) therapy for at&#xD;
             least 4 months and current treatment with one of the following pumps: Omnipod Insulet&#xD;
             (Bedford, MA), Medtronic Minimed Veo insulinPump (MMT-754, MMT-554), Medtronic 640G or&#xD;
             Animas.&#xD;
&#xD;
          5. BMI below 30 kg/m^2&#xD;
&#xD;
          6. Patients willing to follow study instructions (willing to measure capillary blood&#xD;
             glucose as required by their glucose sensor for calibration and use the bolus-&#xD;
             calculator feature of the pump)&#xD;
&#xD;
          7. Patients are required to have minimum computer skills and understanding of navigating&#xD;
             the internet.&#xD;
&#xD;
          8. Patients are required to know basic English.&#xD;
&#xD;
          9. Patients willing to use glucose sensor for study duration.&#xD;
&#xD;
         10. Patients will have to have a smartphone (Apple or Android) or PC with email account.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An episode of diabetic ketoacidosis within the month prior to study entry&#xD;
&#xD;
          2. 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;
          3. Current participation in any other interventional study.&#xD;
&#xD;
          4. Known or suspected allergy to trial products such as adhesives, tapes, needles.&#xD;
&#xD;
          5. Female subject who is pregnant or lactating or planning to become pregnant within the&#xD;
             planned study duration&#xD;
&#xD;
          6. Severe hypoglycemia within six months prior to enrollment as defined by the ADA and&#xD;
             Endocrine society as follows: Severe hypoglycaemia is an event requiring assistance of&#xD;
             another person (due to change in mental status) to actively administer carbohydrates,&#xD;
             glucagon, or take othe corrective actions.&#xD;
&#xD;
          7. Current use of the following medications: medications that are use 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.&#xD;
&#xD;
          8. Hypoglycemia unawareness&#xD;
&#xD;
          9. 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 proliferative retinopathy.&#xD;
&#xD;
               -  Active gastroparesis&#xD;
&#xD;
         10. Patient suffers from eating disorder. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Schnider Children's medical center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</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, 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/NCT03774069
org study id: RMC040818ctil
nct id: NCT03774069
lead sponsor: 
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. DreaMed
      Advisor Pro is a decision- support software intended for assisting healthcare professionals
      in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery
      therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or
      CGM and self-management blood glucose meter.

      The main objective of the proposed study is to test the safety, reliability, and efficacy of
      the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient
      without a physician review.

      Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed
      Advisor Pro) or control group (standard of care). Participants will download the CGM and pump
      data at no less frequent than every 4 weeks for both groups during the 3 months period of the
      study.

      Each time new data is received, the following actions will be performed:

      In the intervention group, a new algorithm recommendation for pump settings will be issued.
      The recommendation will be approved by a technical, non-physician to assure that glucose data
      are not fall within predefined safety criteria which require a physician approval before the
      recommendation will be sent to the patient, otherwise, recommendation will be sent directly
      to the patient.

      In the control group, if no safety criteria is met, it is the responsibility of the patient
      to contact his/her physician to advise on change of treatment. In case a safety issue has
      occurred, the physician will contact the patient and change the pump settings.

      Prior to initiating the interventional phase of the study, we will evaluate the experience of
      patients in self adjustments of insulin dosing in regular care management and to evaluate
      their acceptance for using an automated dosing recommendations software. The evaluation will
      be done by asking patients/caregivers to fill 15 questions survey. 100 patients are
      anticipated to participate in this phase of the study.
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 10mmol/L)
time frame: Final visit (week 12)
measure: Percentage of readings below 54 mg/dl (3.3 mmol/l)
time frame: Final visit (week 12)
measure: HbA1c
time frame: Final visit (week 12)
measure: Diabetes treatment satisfaction questionnaire
time frame: Final visit (week 12)
description: The questionnaire contains 12-14 items (12 for the teens version and 14 for the parents version) the subscale for each items is from 0 to 6, and for most items the the higher the score, the greater the satisfaction with the treatment.Subscales are summed. More specific instruction for analysis are detailed in Diabetologia 52:(suppl 1) S397, Abstruct 1013 and in a document named "Summary of recommended scoring" by Prof. Bradley, University of London
measure: Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
time frame: Final visit (week 12)
measure: Percentage of readings below 60 mg/dl (3.35mmol/L)
time frame: Final visit (week 12)
measure: Percentage of readings above 180 mg/dl (10.0mmol/L)
time frame: Final visit (week 12)
measure: percentage of readings above 250 mg/dl (13.9 mmol/L)
time frame: Final visit (week 12)
measure: Area above the curve of glucose level of 180 mg/dl
time frame: Final visit (week 12)
measure: Area above the curve of glucose level above180 mg/dl
time frame: Final visit (week 12)
measure: Area under the curve of glucose level of 70 mg/dl
time frame: Final visit (week 12)
measure: Area under the curve of glucose level below 70 mg/dl
time frame: Final visit (week 12)
measure: Mean sensor blood glucose
time frame: Final visit (week 12)
measure: Glucose variability measured by standard deviation
time frame: Final visit (week 12)
measure: Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period
time frame: Final visit (week 12)
measure: Number of recommendations for changes in settings per patient
time frame: Final visit (week 12)
measure: Number of recommendations for changes in settings per iteration
time frame: Final visit (week 12)
measure: Number of physician override Advisor recommendation
time frame: Final visit (week 12)
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 recommendation
arm group type: Active Comparator
description: Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration 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 and sent directly to the patient
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 according to standard of care
arm group label: Control group- medical guided recommendation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No