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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tube Fed Participants | Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | Measured in Kg | Baseline to Study Exit Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Malnutrition Universal Screening Tool (MUST) | HCP completed screening tool | Baseline to Study Exit Week 12 |
| Subjective Global Assessment (SGA) | HCP completed nutrition assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality | Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction | Baseline to Study Exit Week 12 |
| Physician Product Satisfaction |
Inclusion Criteria:
Exclusion Criteria:
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Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Camprubi Robles, PhD | Abbott | Study Chair |
| Angela M Palmero, MD | Hospital San Pedro de La Rioja | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Pedro | Logroño | La Rioja | 26006 | Spain | ||
| Hospital Costa del Sol 3095 |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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 |
| Albumin Levels | Nutrition status parameter collected per standard of care | Baseline to Study Exit Week 12 |
Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction
| Baseline to Study Exit Week 12 |
| Marbella |
| Málaga |
| 29603 |
| Spain |
| Hospital Costa del Sol 3178 | Marbella | Málaga | 29603 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Gomez-Ulla | Madrid | 28047 | Spain |
| Centro Médico San juan de la Cruz | Málaga | 29007 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| D004700 | Endocrine System Diseases |