<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/NCT01726829</url>
  </required_header>
  <id_info>
    <org_study_id>rmc007053ctil</org_study_id>
    <nct_id>NCT01726829</nct_id>
  </id_info>
  <brief_title>Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home</brief_title>
  <official_title>Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home, Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized prospective single blind trial to evaluate blood glucose control&#xD;
      overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system&#xD;
      in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia&#xD;
      and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will&#xD;
      participate in four consecutive over nights under closed-loop with MDLAP, and four additional&#xD;
      over nights under regular sensor augmented pump therapy at home with a washout period of 10 ±&#xD;
      3 days between arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last two decades, remarkable technological progress has been made with the development&#xD;
      of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless&#xD;
      communications, interest in the closed-loop insulin delivery was revived.&#xD;
&#xD;
      Control trails that evaluate the clinical benefits of continuous glucose sensor have shown&#xD;
      improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower&#xD;
      hypoglycemic episodes although not significant and no significant change in sever&#xD;
      hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the&#xD;
      patient, the flow of information and the need to act accordingly makes this devise a burden&#xD;
      for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to&#xD;
      an artificial pancreas in a closed-loop system can mimic the activity of functioning&#xD;
      pancreatic beta cells, with strict control of blood glucose levels. Such a system may also&#xD;
      offer an opportunity to free the patients from the daily burden of dealing with their&#xD;
      diabetes.&#xD;
&#xD;
      Study Objectives are to determine the safety and efficacy of using the MDLAP system to&#xD;
      automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose&#xD;
      control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time&#xD;
      (7:00 AM).&#xD;
&#xD;
      This is a randomized prospective single blind trial to evaluate blood glucose control&#xD;
      overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system&#xD;
      in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia&#xD;
      and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in&#xD;
      four consecutive over nights under closed-loop with MDLAP, and four additional over nights&#xD;
      under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days&#xD;
      between arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time sensor glucose level spent below 70mg/dl</measure>
    <time_frame>final visit (day 44)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The time sensor glucose level spent within 70-140 mg/dl</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number and frequency of hypoglycemic events below 63, 79 mg/dl</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time sensor glucose level spent above 140, 180 mg/dl</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the curve &lt;63, &lt;70, &gt;140, &gt;180 mg/dl</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose variability</measure>
    <time_frame>At final visit (day 44)</time_frame>
    <description>glucose variability measured as the standard deviation from the mean glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total insulin dose during the overnight period</measure>
    <time_frame>At the final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Artificial pancreas technical performance defined as total frequency of technical failures</measure>
    <time_frame>at final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records</measure>
    <time_frame>At final vist (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of active closed loop control</measure>
    <time_frame>At final visit (day 44)</time_frame>
    <description>percentage of time that the MDLAP system worked without any technical problem</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of Hypoglycemia questionnaire</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance questionnaire</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Artificial Pancreas Satisfaction Questionnaire</measure>
    <time_frame>At final visit (day 44)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>MD-Logic Artificial Pancreas (MDLAP) system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment with sensor augmented pump therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MD-Logic Artificial Pancreas (MDLAP) system</intervention_name>
    <arm_group_label>MD-Logic Artificial Pancreas (MDLAP) system</arm_group_label>
    <other_name>four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sensor augmented pump therapy</intervention_name>
    <arm_group_label>Standard treatment with sensor augmented pump therapy</arm_group_label>
    <other_name>four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with Type 1 diabetes (&gt;1yr since diagnosis)&#xD;
&#xD;
          -  Insulin infusion pump therapy for at least 3 months&#xD;
&#xD;
          -  Patients whom used continuous glucose sensor previously&#xD;
&#xD;
          -  Age at inclusion ≥ 10 years and ≤ 65 years&#xD;
&#xD;
          -  HbA1c at inclusion ≥ 7 and &lt;10&#xD;
&#xD;
          -  Patients willing to follow study instructions&#xD;
&#xD;
          -  Patients live with at least one other adult person&#xD;
&#xD;
          -  BMI SDS(Standard Deviation Score) - below the 97th percentile for age&#xD;
&#xD;
          -  An internet connection at patient's home&#xD;
&#xD;
          -  Patients with care givers who are capable of operating a computer based system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant diseases that influence metabolic control&#xD;
&#xD;
          -  Participation in any other interventional study&#xD;
&#xD;
          -  Known or suspected allergy to trial products&#xD;
&#xD;
          -  Any significant diseases (such as preexisting seizures or epilepsy) or conditions&#xD;
             including psychiatric disorders and substance abuse that in the opinion of the&#xD;
             investigator is likely to affect the subjects ability to complete the study or&#xD;
             compromise patients safety&#xD;
&#xD;
          -  Diabetic ketoacidosis in the past 1 month&#xD;
&#xD;
          -  Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior&#xD;
             to enrollment.&#xD;
&#xD;
          -  Current use of oral glucocorticoids or other medications, which in the judgment of the&#xD;
             investigator would be a contraindication to participation in the study&#xD;
&#xD;
          -  Female subject who is pregnant or planning to become pregnant within the planned study&#xD;
             duration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moshe Phillip, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes -Zentrum fuer kinder und jugendliche</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center</name>
      <address>
        <city>Petah-Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital</name>
      <address>
        <city>Slovenia</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Israel</country>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>April 7, 2016</last_update_submitted>
  <last_update_submitted_qc>April 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Artificial Pancreas</keyword>
  <keyword>Closed Loop</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>Pancrelipase</mesh_term>
    <mesh_term>Pancreatin</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/NCT01726829
org study id: rmc007053ctil
nct id: NCT01726829
lead sponsor: 
has dmc: No
This is a randomized prospective single blind trial to evaluate blood glucose control
      overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system
      in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia
      and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will
      participate in four consecutive over nights under closed-loop with MDLAP, and four additional
      over nights under regular sensor augmented pump therapy at home with a washout period of 10 ±
      3 days between arms.
In the last two decades, remarkable technological progress has been made with the development
      of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless
      communications, interest in the closed-loop insulin delivery was revived.

      Control trails that evaluate the clinical benefits of continuous glucose sensor have shown
      improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower
      hypoglycemic episodes although not significant and no significant change in sever
      hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the
      patient, the flow of information and the need to act accordingly makes this devise a burden
      for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to
      an artificial pancreas in a closed-loop system can mimic the activity of functioning
      pancreatic beta cells, with strict control of blood glucose levels. Such a system may also
      offer an opportunity to free the patients from the daily burden of dealing with their
      diabetes.

      Study Objectives are to determine the safety and efficacy of using the MDLAP system to
      automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose
      control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time
      (7:00 AM).

      This is a randomized prospective single blind trial to evaluate blood glucose control
      overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system
      in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia
      and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in
      four consecutive over nights under closed-loop with MDLAP, and four additional over nights
      under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days
      between arms.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: time sensor glucose level spent below 70mg/dl
time frame: final visit (day 44)
measure: The percentage of nights mean overnight sensor glucose levels was within90-140 mg/dl
time frame: At final visit (day 44)
measure: The time sensor glucose level spent within 70-140 mg/dl
time frame: At final visit (day 44)
measure: The number and frequency of hypoglycemic events below 63, 79 mg/dl
time frame: At final visit (day 44)
measure: The time sensor glucose level spent above 140, 180 mg/dl
time frame: At final visit (day 44)
measure: The area under the curve <63, <70, >140, >180 mg/dl
time frame: At final visit (day 44)
measure: Glucose variability
time frame: At final visit (day 44)
description: glucose variability measured as the standard deviation from the mean glucose
measure: The total insulin dose during the overnight period
time frame: At the final visit (day 44)
measure: Artificial pancreas technical performance defined as total frequency of technical failures
time frame: at final visit (day 44)
measure: Artificial pancreas technical performance defined as total frequency of lost or inaccurate sensor records
time frame: At final vist (day 44)
measure: Percentage of time of active closed loop control
time frame: At final visit (day 44)
description: percentage of time that the MDLAP system worked without any technical problem
measure: Fear of Hypoglycemia questionnaire
time frame: At final visit (day 44)
measure: Acceptance questionnaire
time frame: At final visit (day 44)
measure: Artificial Pancreas Satisfaction Questionnaire
time frame: At final visit (day 44)
arm group label: MD-Logic Artificial Pancreas (MDLAP) system
arm group type: Experimental
description: four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system
arm group label: Standard treatment with sensor augmented pump therapy
arm group type: Active Comparator
description: four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy
intervention type: Device
intervention name: MD-Logic Artificial Pancreas (MDLAP) system
arm group label: MD-Logic Artificial Pancreas (MDLAP) system
other name: four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system
intervention type: Procedure
intervention name: sensor augmented pump therapy
arm group label: Standard treatment with sensor augmented pump therapy
other name: four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy
criteria: 
gender: All
minimum age: 10 Years
maximum age: 65 Years
healthy volunteers: No
last name: Moshe Phillip, MD
role: Principal Investigator
affiliation: Schneider Children's Medical Center
facility: 
facility: 
facility: 
country: Germany
country: Israel
country: Slovenia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Pancrelipase
mesh term: Pancreatin