Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Has any of the following types of diabetes:

2. Type 1 diabetes

3. Type 2 diabetes

4. Prediabetes

5. Has Malnutrition Universal Screening Tool (MUST) score of ≥ 1

6. Serum albumin less than 3.5 g/dL

7. Energy or protein intake less than recommended

8. BMI less than 30.0 kg/m2

9. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study

10. Female of childbearing potential to use an effective method of birth control

11. Chronic medication type and dose to be constant and maintained throughout the study

12. Willing to follow the protocol throughout the study

13. At least a two-week washout period between the completion of a previous research study and start in current study

14. Willing to refrain from taking non-study diabetes-specific formula over the course of the study.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Has a screening HbA1c level less than 5.7% or ≥ 10%

2. Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks

3. Has active malignancy within the last 5 years

4. Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure

5. Has end-stage organ failure or is post-organ transplant

6. Has current or history of renal disease or on dialysis or severe gastroparesis

7. Has current hepatic disease

8. Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study

9. Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product

10. Has a chronic, contagious, infectious disease

11. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study procedures

12. Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study

13. Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months

14. Has clotting or bleeding disorders

15. Has blood or blood-related diseases

16. Has received blood transfusion within the last 3 weeks

17. Has allergy or intolerance to the study product

18. Anticipated poor compliance to the study as assessed by the Investigator

19. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition