Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care (MENU-DM)
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|ClinicalTrials.gov Identifier: NCT03802942|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : July 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized open label|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- 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
- 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
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
|Contact: Eyal Leibovitz, MDemail@example.com|
|Principal Investigator:||Eyal Leibovitz, MD||Yoseftal Hospital|