<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/NCT03802942</url>
  </required_header>
  <id_info>
    <org_study_id>EL001MENU-DM</org_study_id>
    <nct_id>NCT03802942</nct_id>
  </id_info>
  <brief_title>Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care</brief_title>
  <acronym>MENU-DM</acronym>
  <official_title>Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments, by Means of a Designated Nutritional Care Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eyal Leibovitz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Yoseftal Hospital</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>
      This is a prospective randomized study to evaluate the efficacy of nutritional intervention&#xD;
      for the prevention of hypoglycemia among diabetes patients with low albumin level that are&#xD;
      admitted to internal medicine units, regardless of the reason for admission. All patients&#xD;
      suitable for participation in the study will be asked to participate and be randomized to the&#xD;
      interventional arm or the control arm.&#xD;
&#xD;
      After admission to the internal medicine unit, eligible patients will be asked to participate&#xD;
      in the study. After signing an informed consent form, patients will be randomized to the&#xD;
      treatment or control arms. For patients allocated to the treatment arm, the physician in&#xD;
      charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The&#xD;
      nurse in charge of the patient (at either the morning or evening shifts) will make sure the&#xD;
      patient is receiving and consuming the ONS.&#xD;
&#xD;
      For every patient included in the interventional arm, 2 bottles of GlucernaTM will be&#xD;
      supplied to the patient, one at 08:00 with the morning medications, and one at 16:00 with the&#xD;
      evening medications. For clarification purposes, the GlucernaTM will be supplied on top of&#xD;
      the designated meal plan, as &quot;over-feeding&quot;. Evaluation of adequate ONS consumption will be&#xD;
      performed 2-3 hours after the dispensing of the ONS (at 10:00-11:00 and 19:00-21:00), and the&#xD;
      amount consumed will be documented.&#xD;
&#xD;
      Patients in the control arm will receive no oral nutritional supplementation, and their&#xD;
      caloric intake will be composed of the food supplied by the hospital. Other analysis will be&#xD;
      considered usual care. Additional diet consultations as requested by the medical staff will&#xD;
      constitute usual care, and the patient will continue the study.&#xD;
&#xD;
      The duration of ONS treatment will be the entire length of hospital stay. Upon discharge, a&#xD;
      recommendation to continue nutritional care will be added to the patients' discharge letters&#xD;
      but no oral nutritional supplement (ONS) will be prescribed or dispensed.&#xD;
&#xD;
      Following discharge, a 30-day follow-up call will be made to ascertain whether the patient is&#xD;
      alive, whether the patient was re-admitted or re-hospitalized, and the usage of ONS&#xD;
      prescribed by the family/general practitioner that was consumed after the hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1.2 Definitions: A. Hypoglycemia: a blood glucose level of 70 mg/dL or lower, regardless of&#xD;
      symptoms B. Hypoalbuminemia: Albumin level below 3.5 g/dL upon admission to the hospital C.&#xD;
      Adequate nutritional consumption: the consumption of at least half of the oral nutritional&#xD;
      supplements D. Target population: Diabetes patients admitted to internal medicine units that&#xD;
      have baseline hypoalbuminemia upon admission.&#xD;
&#xD;
      This is a prospective randomized study to evaluate the efficacy of nutritional intervention&#xD;
      for the prevention of hypoglycemia among diabetes patients with low albumin level that are&#xD;
      admitted to internal medicine units, regardless of the reason for admission. All patients&#xD;
      suitable for participation in the study will be asked to participate and be randomized to the&#xD;
      interventional arm or the control arm.&#xD;
&#xD;
      After admission to the internal medicine unit, eligible patients will be asked to participate&#xD;
      in the study. After signing an informed consent form, patients will be randomized to the&#xD;
      treatment or control arms. For patients allocated to the treatment arm, the physician in&#xD;
      charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The&#xD;
      nurse in charge of the patient (at either the morning or evening shifts) will make sure the&#xD;
      patient is receiving and consuming the ONS.&#xD;
&#xD;
      2.3 Study population: All adult patients admitted to internal medicine units of the Wolfson&#xD;
      Medical Center that will participate in the study. The admission to the unit can be either&#xD;
      from the ER or as a transfer from other departments in the hospital.&#xD;
&#xD;
      Inclusion and Exclusion criteria specified above.&#xD;
&#xD;
      Drop-out criteria A. Patients in need of mechanical nutritional support (same as above), as a&#xD;
      complication of the hospitalization.&#xD;
&#xD;
      B. Patients that have a designated nutritional care program recommended by the unit's&#xD;
      dietician that includes ONS. For clarification purposes, fortification of the meal plan by&#xD;
      changing the food items (i.e. low sugar items, high fat/protein and or etc.) will not be&#xD;
      considered a drop-out indication, as long as ONS are not part of the intervention.&#xD;
&#xD;
      C. Patients with undocumented albumin level for the first 72 hours of the hospitalization to&#xD;
      the internal medicine unit.&#xD;
&#xD;
      D. Patients that were enrolled in the study but were transferred from the internal medicine&#xD;
      department to a different unit of treatment during the hospitalization. For clarification&#xD;
      purposes, transfer to interventional radiology, interventional cardiology or any other units&#xD;
      for a specific procedure is not considered a dropout criteria, as long as the patient is back&#xD;
      in the internal medicine unit within 24-48 hours of the procedure.&#xD;
&#xD;
      2.4 Interventional program Interventional arm A. For every patient included in the&#xD;
      interventional arm, 2 bottles of GlucernaTM will be supplied to the patient, one at 08:00&#xD;
      with the morning medications, and one at 16:00 with the evening medications. For&#xD;
      clarification purposes, the GlucernaTM will be supplied on top of the designated meal plan,&#xD;
      as &quot;over-feeding&quot;.&#xD;
&#xD;
      B. Evaluation of adequate ONS consumption will be performed 2-3 hours after the dispensing of&#xD;
      the ONS (at 10:00-11:00 and 19:00-21:00), and the amount consumed will be documented.&#xD;
&#xD;
      C. Patients in the intervention arm that will be unwilling to consume the ONS will not drop&#xD;
      out of the study, but rather the follow-up will continue as usual (ITT design). The ONS will&#xD;
      be offered every day, twice a day, regardless of the answer and the amount consumed. For&#xD;
      patients that decline, the reason for lack of consumption will be documented.&#xD;
&#xD;
      D. The duration of ONS treatment will be the entire length of hospital stay. Upon discharge,&#xD;
      a recommendation to continue nutritional care will be added to the patients' discharge&#xD;
      letters but no ONS will be prescribed or dispensed.&#xD;
&#xD;
      Control arm A. Patients in the control arm will receive no oral nutritional supplementation,&#xD;
      and their caloric intake will be composed of the food supplied by the hospital. Other&#xD;
      analysis (i.e. malnutrition screen, blood tests etc.) will be considered usual care.&#xD;
      Additional diet consultations as requested by the medical staff will constitute usual care,&#xD;
      and the patient will continue the study, as long as no additional ONS are prescribed as part&#xD;
      of the treatment plan (criteria 2 of the drop-out criteria).&#xD;
&#xD;
      B. Upon discharge, a recommendation to continue nutritional care will be added to the&#xD;
      patients' discharge letters but no ONS will be prescribed or dispensed.&#xD;
&#xD;
      Post discharge, all patients&#xD;
&#xD;
      Following discharge, a 30-day follow-up call will be made to ascertain key points:&#xD;
&#xD;
      A. Whether the patient is alive B. Whether the patient was re-admitted or re-hospitalized C.&#xD;
      Usage of ONS prescribed by the family/general practitioner that was consumed after the&#xD;
      hospital discharge.&#xD;
&#xD;
      3.1 informed consent The study will seek the approval of the local Institutional Review Board&#xD;
      (IRB) as an interventional study. All patients participating (either in the treatment or&#xD;
      control arms) will sign an informed consent upon study inclusion.&#xD;
&#xD;
      3.2 Data recording For each patient, a paper case report form (CRF) will be produced. The&#xD;
      patient data recorded in the CRFs will include the following information A. demorgaphic data&#xD;
      A.1. Age, sex, marital status B. Reason for admission, one or more of the following (multiple&#xD;
      selection) B.1. Infection (pneumonia/other) B.2. Acute coronary disease B.3. Acute&#xD;
      cerebrovascular accident (CVA) (all types) C Patient co-morbidities - one or more of the&#xD;
      following (multiple selection) C.1. Hypertension C.2. Hyperlipidemia C.3. Chronic renal&#xD;
      failure C.4. Cerebrovascular disease C.5. Coronary artery disease C.6. Congestive heart&#xD;
      failure C.7. Chronic obstructive pulmonary disease C.8. Dementia (all stages) D Nutritional&#xD;
      assessment - all the following (mandatory for all patients) D.1. Subjective global assessment&#xD;
      D.2. Height (or knee height for patients that cannot be measured) D.3. Weight (or mid arm&#xD;
      circumference for patients that cannot be measured) E Admission laboratory values - all the&#xD;
      following (mandatory for all patients) E.1. Hemoglobin level E.2. White blood cell count E.3.&#xD;
      C-Reactive protein E.4. Albumin and pre-albumin E.5. HbA1c E.6. Creatinine E.7. Recording of&#xD;
      all glucose measurements F Medication plan (mandatory for all patients) F.1. Lipid lowering&#xD;
      drugs (any type any dose) - y/n F.2. Antibiotic treatment (any type any dose) - y/n: for&#xD;
      clarification: any type of antibiotic treatment given orally or by injection (IM, IV,&#xD;
      intra-articular etc.). Topical antibiotics (either ointment or solution) will not be&#xD;
      recorded.&#xD;
&#xD;
      F.3. Gluco-corticoid treatment (any type any dose) - y/n: for clarification: any type of&#xD;
      gluco-corticoid treatment given orally or by injection (IM, IV, intra-articular etc.).&#xD;
      Topical steroid treatment (either ointment or solution) will not be recorded.&#xD;
&#xD;
      F.4. Glucose lowering medications F.4.1. Insulin treatment (any type any dose) - y/n F.4.2.&#xD;
      Glucagon-like peptide-1/Dipeptidyl peptidase-4 inhibitors (GLP1/DPP4i) (any type any dose) -&#xD;
      y/n F.4.3. Metformin (any type any dose) - y/n F.4.4. Other (any type any dose) - y/n G.1.&#xD;
      Meal consumption according to nutrition day analysis - daily 3 meals per day G.2. Glucerna&#xD;
      ONS consumption - 2 bottles dispensed. Each day an estimation of each H Prognostic criteria&#xD;
      H.1. Length of hospital stay - post discharge H.2. In-hospital and/or 30 day mortality (if&#xD;
      applicable) H.3. 30-day readmission (if applicable).&#xD;
&#xD;
      Follow-up call For prognostic criteria assessment, a phone call will be made 30 days after&#xD;
      discharge to ascertain survival and need for hospitalization. Readmission will be any and all&#xD;
      referrals to an emergency room. A distinction will be made if the referral to the ER was&#xD;
      followed by an admission to the hospital. The reason for readmission or re-hospitalization&#xD;
      will not be recorded. For clarification purposes an admission for an elective surgery or&#xD;
      procedure (i.e. coronary angiogram), or an elective admission for continuing care will not be&#xD;
      considered a readmission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 3</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>Randomized open label</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of patients with at least 1 documented low (equal or below 70 mg/dL) glucose levels</measure>
    <time_frame>During the entire hospital stay, estimated up to 60 days</time_frame>
    <description>The number of patients with at least 1 documented glucose levels equal or below 70 mg/dL for the entire study arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of documented low (equal or below 70 mg/dL) glucose levels</measure>
    <time_frame>During the entire hospital stay, estimated up to 60 days</time_frame>
    <description>The number of documented glucose levels equal or below 70 mg/dL for the entire study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>During the entire hospital stay, estimated up to 60 days</time_frame>
    <description>Average length of hospital stay in days of the patients according to study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital and 30-day mortality rates</measure>
    <time_frame>Estimated up to 90 days</time_frame>
    <description>Death of patients occuring during hospitalization or within 30 days from discharge of patients according to study arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day readmission rate</measure>
    <time_frame>During the first 30 days from discharge</time_frame>
    <description>Referral to the Emergency room or readmission to the hospital within 30 days from discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Hypoglycemia</condition>
  <condition>Malnutrition; Diabetes</condition>
  <arm_group>
    <arm_group_label>Glucerna</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 bottles of Glucerna per day (237 ml per bottle for a total of 474 ml/d) on top of the meal plan supplied by the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular meal plan supplied by the hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucerna</intervention_name>
    <description>1 bottle in the morning with breakfast and 1 bottle in the evening with dinner</description>
    <arm_group_label>Glucerna</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admission to internal medicine units &amp;&#xD;
&#xD;
          -  Diabetes mellitus type 2 &amp;&#xD;
&#xD;
          -  Admission serum-albumin level below 3.5 gr/dL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nasogastric [NG] tube&#xD;
&#xD;
          -  percutaneous endoscopic gastrostomy [PEG]&#xD;
&#xD;
          -  feeding jejunostomy&#xD;
&#xD;
          -  total parenteral nutrition [TPN]&#xD;
&#xD;
          -  chemotherapy or immunotherapy for malignancy during the past 6 months&#xD;
&#xD;
          -  Malignancy with life expectancy of less than 6 months&#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>Eyal Leibovitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yoseftal Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eyal Leibovitz, MD</last_name>
    <phone>+972-8-6758043</phone>
    <email>heartman@matav.net.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yoseftal hospital</name>
      <address>
        <city>Eilat</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eyal Leibovitz, MD</last_name>
      <phone>+972-8-6758043</phone>
      <email>heartman@matav.net.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Doron Menachemi, MD</last_name>
      <phone>+972-3-5028636</phone>
      <email>doron.menachemi@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Yoseftal Hospital</investigator_affiliation>
    <investigator_full_name>Eyal Leibovitz</investigator_full_name>
    <investigator_title>Chair, Internal medicine unit B, Laniado hospital</investigator_title>
  </responsible_party>
  <keyword>hypoglycemia</keyword>
  <keyword>diabetes mellitus</keyword>
  <keyword>malnutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Hypoglycemia</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/NCT03802942
org study id: EL001MENU-DM
nct id: NCT03802942
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomized study to evaluate the efficacy of nutritional intervention
      for the prevention of hypoglycemia among diabetes patients with low albumin level that are
      admitted to internal medicine units, regardless of the reason for admission. All patients
      suitable for participation in the study will be asked to participate and be randomized to the
      interventional arm or the control arm.

      After admission to the internal medicine unit, eligible patients will be asked to participate
      in the study. After signing an informed consent form, patients will be randomized to the
      treatment or control arms. For patients allocated to the treatment arm, the physician in
      charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The
      nurse in charge of the patient (at either the morning or evening shifts) will make sure the
      patient is receiving and consuming the ONS.

      For every patient included in the interventional arm, 2 bottles of GlucernaTM will be
      supplied to the patient, one at 08:00 with the morning medications, and one at 16:00 with the
      evening medications. For clarification purposes, the GlucernaTM will be supplied on top of
      the designated meal plan, as "over-feeding". Evaluation of adequate ONS consumption will be
      performed 2-3 hours after the dispensing of the ONS (at 10:00-11:00 and 19:00-21:00), and the
      amount consumed will be documented.

      Patients in the control arm will receive no oral nutritional supplementation, and their
      caloric intake will be composed of the food supplied by the hospital. Other analysis will be
      considered usual care. Additional diet consultations as requested by the medical staff will
      constitute usual care, and the patient will continue the study.

      The duration of ONS treatment will be the entire length of hospital stay. Upon discharge, a
      recommendation to continue nutritional care will be added to the patients' discharge letters
      but no oral nutritional supplement (ONS) will be prescribed or dispensed.

      Following discharge, a 30-day follow-up call will be made to ascertain whether the patient is
      alive, whether the patient was re-admitted or re-hospitalized, and the usage of ONS
      prescribed by the family/general practitioner that was consumed after the hospital discharge.
1.2 Definitions: A. Hypoglycemia: a blood glucose level of 70 mg/dL or lower, regardless of
      symptoms B. Hypoalbuminemia: Albumin level below 3.5 g/dL upon admission to the hospital C.
      Adequate nutritional consumption: the consumption of at least half of the oral nutritional
      supplements D. Target population: Diabetes patients admitted to internal medicine units that
      have baseline hypoalbuminemia upon admission.

      This is a prospective randomized study to evaluate the efficacy of nutritional intervention
      for the prevention of hypoglycemia among diabetes patients with low albumin level that are
      admitted to internal medicine units, regardless of the reason for admission. All patients
      suitable for participation in the study will be asked to participate and be randomized to the
      interventional arm or the control arm.

      After admission to the internal medicine unit, eligible patients will be asked to participate
      in the study. After signing an informed consent form, patients will be randomized to the
      treatment or control arms. For patients allocated to the treatment arm, the physician in
      charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The
      nurse in charge of the patient (at either the morning or evening shifts) will make sure the
      patient is receiving and consuming the ONS.

      2.3 Study population: All adult patients admitted to internal medicine units of the Wolfson
      Medical Center that will participate in the study. The admission to the unit can be either
      from the ER or as a transfer from other departments in the hospital.

      Inclusion and Exclusion criteria specified above.

      Drop-out criteria A. Patients in need of mechanical nutritional support (same as above), as a
      complication of the hospitalization.

      B. Patients that have a designated nutritional care program recommended by the unit's
      dietician that includes ONS. For clarification purposes, fortification of the meal plan by
      changing the food items (i.e. low sugar items, high fat/protein and or etc.) will not be
      considered a drop-out indication, as long as ONS are not part of the intervention.

      C. Patients with undocumented albumin level for the first 72 hours of the hospitalization to
      the internal medicine unit.

      D. Patients that were enrolled in the study but were transferred from the internal medicine
      department to a different unit of treatment during the hospitalization. For clarification
      purposes, transfer to interventional radiology, interventional cardiology or any other units
      for a specific procedure is not considered a dropout criteria, as long as the patient is back
      in the internal medicine unit within 24-48 hours of the procedure.

      2.4 Interventional program Interventional arm A. For every patient included in the
      interventional arm, 2 bottles of GlucernaTM will be supplied to the patient, one at 08:00
      with the morning medications, and one at 16:00 with the evening medications. For
      clarification purposes, the GlucernaTM will be supplied on top of the designated meal plan,
      as "over-feeding".

      B. Evaluation of adequate ONS consumption will be performed 2-3 hours after the dispensing of
      the ONS (at 10:00-11:00 and 19:00-21:00), and the amount consumed will be documented.

      C. Patients in the intervention arm that will be unwilling to consume the ONS will not drop
      out of the study, but rather the follow-up will continue as usual (ITT design). The ONS will
      be offered every day, twice a day, regardless of the answer and the amount consumed. For
      patients that decline, the reason for lack of consumption will be documented.

      D. The duration of ONS treatment will be the entire length of hospital stay. Upon discharge,
      a recommendation to continue nutritional care will be added to the patients' discharge
      letters but no ONS will be prescribed or dispensed.

      Control arm A. Patients in the control arm will receive no oral nutritional supplementation,
      and their caloric intake will be composed of the food supplied by the hospital. Other
      analysis (i.e. malnutrition screen, blood tests etc.) will be considered usual care.
      Additional diet consultations as requested by the medical staff will constitute usual care,
      and the patient will continue the study, as long as no additional ONS are prescribed as part
      of the treatment plan (criteria 2 of the drop-out criteria).

      B. Upon discharge, a recommendation to continue nutritional care will be added to the
      patients' discharge letters but no ONS will be prescribed or dispensed.

      Post discharge, all patients

      Following discharge, a 30-day follow-up call will be made to ascertain key points:

      A. Whether the patient is alive B. Whether the patient was re-admitted or re-hospitalized C.
      Usage of ONS prescribed by the family/general practitioner that was consumed after the
      hospital discharge.

      3.1 informed consent The study will seek the approval of the local Institutional Review Board
      (IRB) as an interventional study. All patients participating (either in the treatment or
      control arms) will sign an informed consent upon study inclusion.

      3.2 Data recording For each patient, a paper case report form (CRF) will be produced. The
      patient data recorded in the CRFs will include the following information A. demorgaphic data
      A.1. Age, sex, marital status B. Reason for admission, one or more of the following (multiple
      selection) B.1. Infection (pneumonia/other) B.2. Acute coronary disease B.3. Acute
      cerebrovascular accident (CVA) (all types) C Patient co-morbidities - one or more of the
      following (multiple selection) C.1. Hypertension C.2. Hyperlipidemia C.3. Chronic renal
      failure C.4. Cerebrovascular disease C.5. Coronary artery disease C.6. Congestive heart
      failure C.7. Chronic obstructive pulmonary disease C.8. Dementia (all stages) D Nutritional
      assessment - all the following (mandatory for all patients) D.1. Subjective global assessment
      D.2. Height (or knee height for patients that cannot be measured) D.3. Weight (or mid arm
      circumference for patients that cannot be measured) E Admission laboratory values - all the
      following (mandatory for all patients) E.1. Hemoglobin level E.2. White blood cell count E.3.
      C-Reactive protein E.4. Albumin and pre-albumin E.5. HbA1c E.6. Creatinine E.7. Recording of
      all glucose measurements F Medication plan (mandatory for all patients) F.1. Lipid lowering
      drugs (any type any dose) - y/n F.2. Antibiotic treatment (any type any dose) - y/n: for
      clarification: any type of antibiotic treatment given orally or by injection (IM, IV,
      intra-articular etc.). Topical antibiotics (either ointment or solution) will not be
      recorded.

      F.3. Gluco-corticoid treatment (any type any dose) - y/n: for clarification: any type of
      gluco-corticoid treatment given orally or by injection (IM, IV, intra-articular etc.).
      Topical steroid treatment (either ointment or solution) will not be recorded.

      F.4. Glucose lowering medications F.4.1. Insulin treatment (any type any dose) - y/n F.4.2.
      Glucagon-like peptide-1/Dipeptidyl peptidase-4 inhibitors (GLP1/DPP4i) (any type any dose) -
      y/n F.4.3. Metformin (any type any dose) - y/n F.4.4. Other (any type any dose) - y/n G.1.
      Meal consumption according to nutrition day analysis - daily 3 meals per day G.2. Glucerna
      ONS consumption - 2 bottles dispensed. Each day an estimation of each H Prognostic criteria
      H.1. Length of hospital stay - post discharge H.2. In-hospital and/or 30 day mortality (if
      applicable) H.3. 30-day readmission (if applicable).

      Follow-up call For prognostic criteria assessment, a phone call will be made 30 days after
      discharge to ascertain survival and need for hospitalization. Readmission will be any and all
      referrals to an emergency room. A distinction will be made if the referral to the ER was
      followed by an admission to the hospital. The reason for readmission or re-hospitalization
      will not be recorded. For clarification purposes an admission for an elective surgery or
      procedure (i.e. coronary angiogram), or an elective admission for continuing care will not be
      considered a readmission.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized open label
primary purpose: Prevention
masking: None (Open Label)
measure: Total number of patients with at least 1 documented low (equal or below 70 mg/dL) glucose levels
time frame: During the entire hospital stay, estimated up to 60 days
description: The number of patients with at least 1 documented glucose levels equal or below 70 mg/dL for the entire study arm
measure: Total number of documented low (equal or below 70 mg/dL) glucose levels
time frame: During the entire hospital stay, estimated up to 60 days
description: The number of documented glucose levels equal or below 70 mg/dL for the entire study arm
measure: Length of hospital stay
time frame: During the entire hospital stay, estimated up to 60 days
description: Average length of hospital stay in days of the patients according to study arm
measure: In-hospital and 30-day mortality rates
time frame: Estimated up to 90 days
description: Death of patients occuring during hospitalization or within 30 days from discharge of patients according to study arm
measure: 30-day readmission rate
time frame: During the first 30 days from discharge
description: Referral to the Emergency room or readmission to the hospital within 30 days from discharge
arm group label: Glucerna
arm group type: Experimental
description: 2 bottles of Glucerna per day (237 ml per bottle for a total of 474 ml/d) on top of the meal plan supplied by the hospital.
arm group label: Control
arm group type: No Intervention
description: Regular meal plan supplied by the hospital
intervention type: Dietary Supplement
intervention name: Glucerna
description: 1 bottle in the morning with breakfast and 1 bottle in the evening with dinner
arm group label: Glucerna
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eyal Leibovitz, MD
role: Principal Investigator
affiliation: Yoseftal Hospital
last name: Eyal Leibovitz, MD
phone: +972-8-6758043
email: heartman@matav.net.il
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Yoseftal Hospital
investigator full name: Eyal Leibovitz
investigator title: Chair, Internal medicine unit B, Laniado hospital
mesh term: Diabetes Mellitus
mesh term: Malnutrition
mesh term: Hypoglycemia
sharing ipd: No