Evaluating a diabetes-specific nutritional formula

Clinical Efficacy and Safety of Diabetes-Specific Formula (Nutren Diabetes) for Nutritional Support in Diabetic Patients With Dysphagia

This study tests whether a new diabetes-specific nutritional formula works better and is safer than another formula for people with diabetes over about nine days.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT05859165 on ClinicalTrials.gov

What this trial studies

This study compares the clinical efficacy and safety of Nutren Diabetes against Fresubin Diabetes in patients with diabetes over a period of approximately 9 days. It employs a randomized, active-control, open-label design, assessing various parameters such as the 24-hour area under the curve (AUC) and safety-related laboratory outcomes. Participants will receive one of the two nutritional formulas, and their blood glucose levels and other health indicators will be monitored throughout the intervention period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-90 with diabetes who require tube feeding for more than 9 days and have stable blood glucose control.

Not a fit: Patients with congenital metabolism disorders or allergies to any ingredients in the nutritional products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective nutritional option for managing diabetes in patients requiring tube feeding.

How similar studies have performed: Other studies have explored nutritional interventions in diabetes management, but this specific comparison of Nutren Diabetes and Fresubin Diabetes is novel.

Eligibility criteria

Inclusion Criteria:

* Male or female aged 18-90 years old (inclusive);
* The subjects' blood glucose related indicators meet any of the following conditions:

Diagnosis of diabetes, and recent stable blood glucose control (refer to Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020) for the diagnosis of diabetes); Fasting blood glucose ≥ 7.0mmol/L or random blood glucose ≥ 11.1mmol/L (at least 2 consecutive tests); Blood glucose\>7.8mmol/L (at least 3 consecutive tests, with at least 2 non same day results).

* Glycosylated hemoglobin (HbA1c) \<10.0%;
* Inability to feed orally;
* It is estimated that tube feeding would be required for more than 9 days;
* Patients or their guardians (or authorized personnel) have fully understood the study procedures of this trial and are willing to sign the informed consent form (ICF).

Exclusion Criteria:

* Subjects with congenital metabolism disorder or allergy to any ingredient in the product (such as whey protein, milk protein concentrate, soybean lecithin); those with congenital intolerance to fructose;
* Patients who are not suitable for enteral nutrition, such as those with active gastrointestinal (GI) hemorrhage, intestinal ischemia, paralytic/mechanical ileus, decreased GI tension, stress ulcer, as well as severe abdominal distension, diarrhea and other digestive and absorptive dysfunction. If the above situation exists, but the researchers believe that enteral nutrition is still applicable, screening can be conducted;
* Subjects with severe local broken skin which affects the use of continuous glucose monitoring (CGM) system;
* Subjects who have concurrent severe malnutrition (body mass index \[BMI\] \<15), severe hypertriglyceridemia (triglyceride≥5.6 mmol/L), severe hypoproteinemia (albumin\<20 g/L), severe immunosuppression (neutrophils\<1500/mm3 or lymphocytes\<500/mm3), severe anemia (hemoglobin\<60 g/L), severe infection, high fever and other stress conditions;;
* Subjects with fasting C-peptide \< 100 pmol/L (0.3 ng/mL);
* Patients with active malignant tumor (except for glioma, meningioma) or in the period of radiochemotherapy;
* Patients with severe cardiac failure (New York Heart Association \[NYHA\] Class IV); those with severe liver or renal impaired function (glomerular filtration rate \< 30 mL/min/1.73 m2, or levels of transaminases or transpeptidases more than 3 times the upper limit of normal); or those with conditions such as active hyperthyroidism, treatment-resistant hypothyroidism;
* Subjects with one of the following conditions: hemodynamic instability, life-threatening multiple injuries, as well as severe acidosis, shock, sepsis;
* Recent (within 3 months) acute complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome;
* Subjects who have used systemic glucocorticoid therapy within 2 weeks prior to screening or are expected to use during the study, If the screening requires the use of physiological replacement doses of glucocorticoids for other diseases prior to screening, and the researcher evaluates that the glucocorticoid dose can remain stable during the study period, the subjects can be screened;
* Women who are pregnant or plan to become pregnant or are breastfeeding;
* Life expectancy ≤ 30 days;
* Participated in other interventional clinical trials within 4 weeks prior to screening, including those involved in drugs, nutritional preparations, medical devices, etc.;
* Other cases not eligible for this study in the investigator's opinion, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), acute pancreatitis, unstable vital signs, and if it does, the reasons for ineligibility should be recorded.

Where this trial is running

Beijing

• Peking Union Medical College hospital — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Wei Chen — Peking Union Medical College Hospital
• Study coordinator: Vincent Wang

Conditions: Diabetes Mellitus