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Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care (MENU-DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802942
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by (Responsible Party):
Eyal Leibovitz, Yoseftal Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypoglycemia Malnutrition; Diabetes Dietary Supplement: Glucerna Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open label
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments, by Means of a Designated Nutritional Care Program
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glucerna
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.
Dietary Supplement: Glucerna
1 bottle in the morning with breakfast and 1 bottle in the evening with dinner

No Intervention: Control
Regular meal plan supplied by the hospital



Primary Outcome Measures :
  1. 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 ]
    The number of patients with at least 1 documented glucose levels equal or below 70 mg/dL for the entire study arm


Secondary Outcome Measures :
  1. 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 ]
    The number of documented glucose levels equal or below 70 mg/dL for the entire study arm

  2. Length of hospital stay [ Time Frame: During the entire hospital stay, estimated up to 60 days ]
    Average length of hospital stay in days of the patients according to study arm

  3. In-hospital and 30-day mortality rates [ Time Frame: Estimated up to 90 days ]
    Death of patients occuring during hospitalization or within 30 days from discharge of patients according to study arm

  4. 30-day readmission rate [ Time Frame: During the first 30 days from discharge ]
    Referral to the Emergency room or readmission to the hospital within 30 days from discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • admission to internal medicine units &
  • Diabetes mellitus type 2 &
  • Admission serum-albumin level below 3.5 gr/dL.

Exclusion Criteria:

  • nasogastric [NG] tube
  • percutaneous endoscopic gastrostomy [PEG]
  • feeding jejunostomy
  • total parenteral nutrition [TPN]
  • chemotherapy or immunotherapy for malignancy during the past 6 months
  • Malignancy with life expectancy of less than 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802942


Contacts
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Contact: Eyal Leibovitz, MD +972-8-6758043 heartman@matav.net.il

Locations
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Israel
Yoseftal hospital Recruiting
Eilat, Israel
Contact: Eyal Leibovitz, MD    +972-8-6758043    heartman@matav.net.il   
Wolfson Medical Center Not yet recruiting
Holon, Israel, 58100
Contact: Doron Menachemi, MD    +972-3-5028636    doron.menachemi@gmail.com   
Sponsors and Collaborators
Eyal Leibovitz
Abbott Nutrition
Investigators
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Principal Investigator: Eyal Leibovitz, MD Yoseftal Hospital
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Responsible Party: Eyal Leibovitz, Senior physician, Internal medicine department "A", Yoseftal Hospital
ClinicalTrials.gov Identifier: NCT03802942    
Other Study ID Numbers: EL001MENU-DM
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eyal Leibovitz, Yoseftal Hospital:
hypoglycemia
diabetes mellitus
malnutrition
Additional relevant MeSH terms:
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Diabetes Mellitus
Hypoglycemia
Malnutrition
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders