A Tube Feeding Study in Malnourished Population With Diabetes

Study Overview
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Brief Summary
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This is a prospective, non-interventional, observational study. Malnourished subjects with diabetes, who are receiving a high calorie, high protein tube feeding with slow release carbohydrates and MUFA by their health care professional (HCP) per standard of care will be enrolled into the study.

Official Title
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A Prospective, Observational Study, of a High Calorie, High Protein Tube Feeding With Slow Release Carbohydrates and Monounsaturated Fatty Acids (MUFA), in a Malnourished Population With Diabetes

Conditions
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Malnutrition; Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study Considered malnourished, or at risk for malnutrition Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin Conforms to the requirements set forth on the study product label Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay > 3 days and < 12 days Exclusion Criteria: Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product Renal or liver failure Participates in another study that has not been approved as a concomitant study by AN

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tube Fed Participants<br>Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Change | Measured in Kg | Baseline to Study Exit Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin Levels | Nutrition status parameter collected per standard of care | Baseline to Study Exit Week 12 | 
| Malnutrition Universal Screening Tool (MUST) | HCP completed screening tool | Baseline to Study Exit Week 12 | 
| Subjective Global Assessment (SGA) | HCP completed nutrition assessment | Baseline to Study Exit Week 12 | 
| Quality of life (EuroQol EQ-5D-5L) | Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction | Baseline to Study Exit Week 12 | 
| Glucose control | HbA1c levels | Baseline to Study Exit Week 12 | 
| Body Mass Index | BMI calculated Weight (kg)/Height (m)2 | Baseline to Study Exit Week 12 | 
| Product Compliance | Product consumption diary | Baseline to Study Exit Week 12 |