Status:
UNKNOWN
Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care
Lead Sponsor:
Eyal Leibovitz
Collaborating Sponsors:
Abbott Nutrition
Conditions:
Hypoglycemia
Malnutrition; Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 inter...
Detailed Description
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 nutriti...
Eligibility Criteria
Inclusion
- admission to internal medicine units \&
- Diabetes mellitus type 2 \&
- Admission serum-albumin level below 3.5 gr/dL.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03802942
Start Date
July 1 2019
End Date
December 1 2023
Last Update
April 23 2021
Active Locations (2)
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1
Yoseftal hospital
Eilat, Israel
2
Wolfson Medical Center
Holon, Israel, 58100