New Tube-Feeding formula aims to steady blood sugar in diabetics
NCT ID NCT05859165
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This completed study tested whether a diabetes-specific tube-feeding formula (Nutren Diabetes) can control blood sugar as well as another formula (Fresubin Diabetes) in diabetic patients who have trouble swallowing. 233 adults aged 18-90 took part, receiving tube feeding for up to 12 days. The main goal was to compare average blood sugar levels over 24 hours between the two groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nutren Diabetes (a diabetes-specific tube-feeding formula)
- What this could lead to
- If it works, this could provide a safe and effective nutritional option for diabetic patients who need tube feeding, helping to keep their blood sugar stable.
- What could go wrong
- This is a small, completed non-inferiority trial, so results may not apply to all patients. The formula is a dietary supplement, not a drug, so benefits are limited to nutritional support.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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233 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Peking Union Medical College hospital
Beijing, China
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