xml: <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/NCT06025513</url>
    </required_header>
    <id_info>
      <org_study_id>CA006</org_study_id>
      <nct_id>NCT06025513</nct_id>
    </id_info>
    <brief_title>De-tensioning Silicone Based Bandage, in Subjects With Type 1 Diabetes and Lipohypertrophy</brief_title>
    <official_title>A Phase 1 Study to Assess the Safety and Efficacy of Embrace, a De-tensioning Silicone Based Bandage, in Subjects With Type 1 Diabetes and Lipohypertrophy (LH)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Neodyne Biosciences, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Neodyne Biosciences, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-center, single-cohort, open, repeated-application study. Baseline&#xD;
        assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of&#xD;
        insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with&#xD;
        pre-meal insulin injected into the LH lesion. Subjects will discontinue their basal insulin&#xD;
        for 2-3 days after the Continuous glucose monitor (CGM) study ends, prior to admission to the&#xD;
        research center (&quot;wash-out&quot;). After release from the research center, subjects will wear the&#xD;
        Embrace over the target LH lesion for 16 weeks. At the beginning of week 17, the clamp and&#xD;
        MMTT will be repeated, after which participants will again wear an unblinded CGM for ~6 days&#xD;
        with injections only in the target LH lesion when applying an Embrace bandage with a hole. A&#xD;
        needle biopsy will be taken from the LH lesion at baseline and again at study completion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, single-cohort, open, repeated-application study. Baseline&#xD;
        assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of&#xD;
        insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with&#xD;
        pre-meal insulin injected into the LH lesion. However, before admission to the research&#xD;
        center, unblinded CGM is worn for ~13 days (day 1 is discarded to avoid variability, day 2-7&#xD;
        bolus injections in Normal Tissue (NAT) and day 8-13 bolus injections in target LH) as&#xD;
        outpatients. Subjects will discontinue their basal insulin for 2-3 days after the CGM study&#xD;
        ends, prior to admission to the research center (&quot;wash-out&quot;). After release from the research&#xD;
        center, subjects will wear the Embrace over the target LH lesion for 16 weeks, reapplying the&#xD;
        bandage every week and avoiding any injections in the target LH lesion. Basal insulin is&#xD;
        injected only in NAT away from the LH site. At the beginning of week 17, the clamp and MMTT&#xD;
        will be repeated, after which participants will again wear an unblinded CGM for ~6 days&#xD;
        (again, day 1 is discarded) with injections only in the target LH lesion when applying an&#xD;
        Embrace bandage with a hole. A needle biopsy will be taken from the LH lesion at baseline and&#xD;
        again at study completion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Pre / Post comparison with device treatment for 16 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin</measure>
      <time_frame>16 weeks</time_frame>
      <description>Area under the glucose infusion rate curve (AUCGIR),0-4h: area under the glucose infusion rate curve from 0 to 4 hrs after injection of a 0.15 units/kg body weight dose of insulin lispro</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">29</enrollment>
    <condition>Insulin Resistance</condition>
    <condition>Lipohypertrophy</condition>
    <arm_group>
      <arm_group_label>embrace dressing treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Insulin PK/PD before and after treatment with embrace dressing</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Embrace Dressing</intervention_name>
      <description>Tension offloading skin dressing</description>
      <arm_group_label>embrace dressing treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed and dated informed consent obtained before any trial-related activities.&#xD;
               Trial-related activities are any procedures that would not have been done during&#xD;
               normal management of the subject.&#xD;
  &#xD;
            2. Subject with type 1 diabetes for at least 3 years&#xD;
  &#xD;
            3. One or more palpable lipohypertrophy lesions in the abdominal area, the largest of&#xD;
               which has a minimum size of 3.0 cm and a maximum size of 12.0 cm (longest axis) as&#xD;
               confirmed by ultrasound.&#xD;
  &#xD;
            4. Treated with multiple daily injections (≥3) of insulin for at least 2 years or&#xD;
               continuous subcutaneous insulin infusion for at least 1 year.&#xD;
  &#xD;
            5. Subject is willing and able to continue same basal insulin during trial participation.&#xD;
  &#xD;
            6. Body Mass Index (BMI) 18.5 to 30.0 kg/m², inclusive&#xD;
  &#xD;
            7. HbA1c at screening between 6.5% and 9.5% (inclusive)&#xD;
  &#xD;
            8. Have clinical laboratory test results within the normal range for the population, or&#xD;
               with abnormalities deemed clinically insignificant by the investigator.&#xD;
  &#xD;
            9. Considered generally healthy (apart from type 1 diabetes and lipohypertrophy) upon&#xD;
               completion of medical history and screening safety assessments, as judged by the&#xD;
               Investigator&#xD;
  &#xD;
           10. Have venous access sufficient to allow cannulation for blood sampling as required by&#xD;
               the protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Receipt of any medicinal product in clinical development within 60 days or 5&#xD;
               half-lives (if known) of the medicinal product before randomisation in this trial&#xD;
  &#xD;
            2. Any history or presence of cancer, except for a history of basal cell skin cancer or&#xD;
               squamous cell skin cancer (as judged by the Investigator)&#xD;
  &#xD;
            3. Any history or presence of clinically relevant comorbidity (with the exception of&#xD;
               conditions associated with diabetes mellitus), that may place the subject at increased&#xD;
               risk as determined by the investigator.&#xD;
  &#xD;
            4. Signs of acute illness as judged by the Investigator&#xD;
  &#xD;
            5. Any serious systemic infectious disease during four weeks prior to screening, as&#xD;
               judged by the Investigator.&#xD;
  &#xD;
            6. Aspartate transaminase (AST) and/or Alanine transaminase (ALT) &gt; 2 times the upper&#xD;
               limit of normal&#xD;
  &#xD;
            7. Estimated glomerular filtration rate (eGFR)&lt;60 mL/min&#xD;
  &#xD;
            8. Systolic blood pressure &lt; 90 mmHg or &gt;160 mmHg and/or diastolic blood pressure &lt; 50&#xD;
               mmHg or &gt; 95 mmHg (one repeat test will be acceptable in case of suspected white-coat&#xD;
               hypertension)&#xD;
  &#xD;
            9. Heart rate at rest outside the range of 50-90 beats per minute. This exclusion&#xD;
               criterion also pertains to subjects being on anti-hypertensives.&#xD;
  &#xD;
           10. History of severe hypoglycaemia with seizure, coma or requiring assistance of another&#xD;
               person during the past 6 months&#xD;
  &#xD;
           11. Significant history of alcoholism or drug abuse as judged by the Investigator or&#xD;
               consuming more than 24 grams alcohol/day (for males), 12 grams alcohol/day (for&#xD;
               females) on average&#xD;
  &#xD;
           12. A positive result in the alcohol and/or urine drug screen at the screening visit&#xD;
  &#xD;
           13. Tested positive for Hepatitis Bs antigen&#xD;
  &#xD;
           14. Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will&#xD;
               not lead to exclusion if liver function tests are normal, and a hepatitis C polymerase&#xD;
               chain reaction is negative)&#xD;
  &#xD;
           15. Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen&#xD;
  &#xD;
           16. Have received chronic (lasting &gt;14 consecutive days) systemic glucocorticoid therapy&#xD;
               (excluding topical, intra-articular, and inhaled preparations) in the past 3 months,&#xD;
               or have received any non-topical glucocorticoid therapy within 30 days before&#xD;
               screening&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Insulin Resistance</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025513
  org study id: CA006
  nct id: NCT06025513
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This is a single-center, single-cohort, open, repeated-application study. Baseline
        assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of
        insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with
        pre-meal insulin injected into the LH lesion. Subjects will discontinue their basal insulin
        for 2-3 days after the Continuous glucose monitor (CGM) study ends, prior to admission to the
        research center ("wash-out"). After release from the research center, subjects will wear the
        Embrace over the target LH lesion for 16 weeks. At the beginning of week 17, the clamp and
        MMTT will be repeated, after which participants will again wear an unblinded CGM for ~6 days
        with injections only in the target LH lesion when applying an Embrace bandage with a hole. A
        needle biopsy will be taken from the LH lesion at baseline and again at study completion.
  This is a single-center, single-cohort, open, repeated-application study. Baseline
        assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of
        insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with
        pre-meal insulin injected into the LH lesion. However, before admission to the research
        center, unblinded CGM is worn for ~13 days (day 1 is discarded to avoid variability, day 2-7
        bolus injections in Normal Tissue (NAT) and day 8-13 bolus injections in target LH) as
        outpatients. Subjects will discontinue their basal insulin for 2-3 days after the CGM study
        ends, prior to admission to the research center ("wash-out"). After release from the research
        center, subjects will wear the Embrace over the target LH lesion for 16 weeks, reapplying the
        bandage every week and avoiding any injections in the target LH lesion. Basal insulin is
        injected only in NAT away from the LH site. At the beginning of week 17, the clamp and MMTT
        will be repeated, after which participants will again wear an unblinded CGM for ~6 days
        (again, day 1 is discarded) with injections only in the target LH lesion when applying an
        Embrace bandage with a hole. A needle biopsy will be taken from the LH lesion at baseline and
        again at study completion.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Pre / Post comparison with device treatment for 16 weeks.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin
  time frame: 16 weeks
  description: Area under the glucose infusion rate curve (AUCGIR),0-4h: area under the glucose infusion rate curve from 0 to 4 hrs after injection of a 0.15 units/kg body weight dose of insulin lispro
  arm group label: embrace dressing treatment
  arm group type: Experimental
  description: Insulin PK/PD before and after treatment with embrace dressing
  intervention type: Device
  intervention name: Embrace Dressing
  description: Tension offloading skin dressing
  arm group label: embrace dressing treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Insulin Resistance