Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care

NCT03802942 | Unknown Phase 3 DMC

• 1 other identifier: EL001MENU-DM
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypoglycemia; Malnutrition; Diabetes

Keywords

hypoglycemia; diabetes mellitus; malnutrition

Outcome Measures

Primary Outcomes (1)

• Total number of patients with at least 1 documented low (equal or below 70 mg/dL) glucose levels

  The number of patients with at least 1 documented glucose levels equal or below 70 mg/dL for the entire study arm

  During the entire hospital stay, estimated up to 60 days

Secondary Outcomes (4)

• Total number of documented low (equal or below 70 mg/dL) glucose levels

  During the entire hospital stay, estimated up to 60 days

• Length of hospital stay

  During the entire hospital stay, estimated up to 60 days

• In-hospital and 30-day mortality rates

  Estimated up to 90 days

• 30-day readmission rate

  During the first 30 days from discharge

Study Arms (2)

Glucerna

EXPERIMENTAL

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

Control

NO INTERVENTION

Regular meal plan supplied by the hospital

Interventions

Glucerna DIETARY_SUPPLEMENT

1 bottle in the morning with breakfast and 1 bottle in the evening with dinner

Glucerna

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyal Leibovitz: lead
• Abbott Nutrition: collaborator

Study Sites (2)

Yoseftal hospital

Eilat, Israel

RECRUITING

Wolfson Medical Center

Holon, 58100, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Hypoglycemia; Malnutrition; Diabetes Mellitus

Interventions

Glucerna

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Endocrine System Diseases

Study Officials

• Eyal Leibovitz, MD

  Yoseftal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Leibovitz, MD

CONTACT

+972-8-6758043; heartman@matav.net.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Internal medicine unit B, Laniado hospital

Model Details: Randomized open label

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 14, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)