Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition

Study Overview
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Brief Summary
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This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.

Official Title
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High Calorie and High Protein Diabetes-specific Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition in Real-life Setting: A Post-marketing Observational Study (PMO)

Conditions
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Malnutrition, Diabetes

Intervention / Treatment
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* Other: Oral Nutritional Supplement (ONS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit Adult population with age ≥30 years Willing to follow the protocol as described Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study to allow their data to be collected Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition (MUST≥1), and has recently (within the last 7 days prior to participating in this study) been prescribed study oral nutritional supplement (2 servings/day) by their health care professional Exclusion Criteria: History of T2D longer than 30 years History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS) If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times the upper normal limit), or significant renal disease (GFR < 60 ml/min/1.73m2) History of heart failure (> class II) Follows a non-typical eating pattern, such as very low carbohydrate diet (e.g., Atkins diet, ketogenic diet, high protein diet), strict vegetarianism (e.g., no meat, dairy, eggs). Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration Has current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Baseline Visit. Has an active malignancy Known to be allergic or intolerant to any ingredient found in the study products Taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite modifying medications (examples include orlistat, contrive, incretins, cannabis). Has known dementia, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 days follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved by Abbott Nutrition. Patient is receiving any other oral supplement with HMB for nutritional management in the last 7 days

Ages Eligible for Study
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Minimum Age: 30 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 |
| --- | --- |
| Oral Nutritional Supplement (ONS) Group<br>2 servings per day as per standard of care during the study period | Other: Oral Nutritional Supplement (ONS)<br>* Diabetes specific oral nutritional supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status risk by MUST | Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition | Baseline to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glycemic Measurement | Change in glycemic control markers where lower levels are associated with improved control | Baseline to Day 90 | 
| Handgrip Strength | Change in handgrip as measured in kg | Baseline to Day 90 | 
| Chair Stand Test | Change in test score where higher number of times completed is more favorable | Baseline to Day 90 | 
| Body Composition | Change in body composition where increased fat free mass is more favorable | Baseline to Day 90 | 
| EQ-5D Quality of Life | Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline to Day 90 | 
| Diabetes Distress Scale | Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable | Baseline to Day 90 | 
| Subjective Global Assessment | Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished | Baseline to Day 90 | 
| Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition | Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria | Baseline to Day 90 |