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| Name | Class |
|---|---|
| Nestle Health Science | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutren Diabetes group | Experimental | Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day |
|
| Fresubin Diabetes group | Active Comparator | Product Replacement phase: 1-5 days, tube-feeding, 25kcal/kg/day Formal intervention phase:7 days, tube-feeding, 25kcal/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutren Diabetes | Dietary Supplement | Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24h AUC of Nutren Diabetes group with Fresubin Diabetes group | mean area under the blood glucose concentration-time curve from time 0 to 24h (24h AUC) | 2-4 days since the start of formal intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation of blood glucose | CV data from CGM | Day 2 upon formal intervention |
| Time in range | TIR from CGM | Day 2 - 4 upon formal intervention |
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Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Chen | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College hospital | Beijing | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Fresubin Diabetes | Dietary Supplement | Product replace phase: 1-5 days, tube feeding, 25kcal/kg/day Formal intervention phase:7 days, tube feeding, 25kcal/kg/day |
|
| Time above range | TAR from CGM | Day 2 - 4 upon formal intervention |
| Time below range | TBR from CGM | Day 2 - 4 upon formal intervention |
| Mean amplitude of glycemic excursion | MAGE from CGM | Day 2 - 4 upon formal intervention |
| Peak blood glucose | Peak blood from CGM | Day 4 upon formal intervention |
| Fasting plasma glucose | FPG from laboratory test | Day 7 upon formal intervention |
| Prealbumin | Prealbumin from laboratory test | Day 7 upon formal intervention |
| Albumin | Albumin from laboratory test | Day 7 upon formal intervention |