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Nutritional support for people with Type 2 diabetes at risk of malnutrition

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)

Observational Abbott Nutrition · NCT05913193

This study tests whether a special nutritional drink taken twice a day can help adults with Type 2 diabetes who are at risk of malnutrition feel better and improve their health.

Quick facts

Study typeObservational
Enrollment260 (estimated)
Ages30 Years and up
SexAll
SponsorAbbott Nutrition Industry-sponsored
Locations19 sites (Córdoba, Cordoba and 18 other locations)
Trial IDNCT05913193 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective study evaluates the impact of a diabetes-specific oral nutritional supplement taken twice daily on the nutritional status of patients with Type 2 diabetes who are either malnourished or at risk of malnutrition. Participants must be adults aged 30 and older, currently receiving treatment for diabetes, and have a recent HbA1c level below 9.0%. The study aims to assess how this nutritional intervention can improve health outcomes in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 and older with Type 2 diabetes who are currently being treated and are at risk of malnutrition.

Not a fit: Patients with a history of Type 2 diabetes longer than 30 years or those who have experienced diabetic ketoacidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the nutritional status and overall health of patients with Type 2 diabetes who are at risk of malnutrition.

How similar studies have performed: Other studies have shown positive outcomes with nutritional interventions in diabetes management, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Córdoba, Cordoba and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MalnutritionDiabetes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.