Diabetes Mellitus
Conditions
Brief summary
This study has a parallel, non-inferiority design, comparing the 24h AUC of Nutren Diabetes group with Fresubin Diabetes group at 2-4 days since the start of formal intervention.
Detailed description
This is a randomized, active-control, open labelled study in which either Nutren Diabetes or Fresubin Diabetes will be given to patients with diabetes for around 9 days. 24h AUC, TIR, TBR, prealbumin albumin etc. will be evaluated. And also safety-related laboratory parameters, numbers, severity, outcome of AEs will be evaluated too.
Interventions
DIETARY_SUPPLEMENTNutren Diabetes
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
DIETARY_SUPPLEMENTFresubin Diabetes
Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day
Sponsors
Nestle Health Science
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24h AUC of Nutren Diabetes group with Fresubin Diabetes group | 2-4 days since the start of formal intervention | mean area under the blood glucose concentration-time curve from time 0 to 24h (24h AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | Day 2 - 4 upon formal intervention | TIR from CGM |
| Time above range | Day 2 - 4 upon formal intervention | TAR from CGM |
| Time below range | Day 2 - 4 upon formal intervention | TBR from CGM |
| Mean amplitude of glycemic excursion | Day 2 - 4 upon formal intervention | MAGE from CGM |
| Coefficient of variation of blood glucose | Day 2 upon formal intervention | CV data from CGM |
| Fasting plasma glucose | Day 7 upon formal intervention | FPG from laboratory test |
| Prealbumin | Day 7 upon formal intervention | Prealbumin from laboratory test |
| Albumin | Day 7 upon formal intervention | Albumin from laboratory test |
| Peak blood glucose | Day 4 upon formal intervention | Peak blood from CGM |
Countries
China
Outcome results
None listed