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Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)
In people with malnutrition and diabetes who require oral supplementation, there is no evidence clear when choosing a specific supplement for diabetes or a standard supplement. To date, there are no studies evaluating flash glucose monitoring in people with DM2 with supplements, nor studies comparing formulas specific for diabetes with standard formulas. Patients with type 2 diabetes, malnutrition and requiring oral nutritional supplements for 3 months will be included in the study.
A standard supplement (minimum 2 per day) will be prescribed for 2 weeks, an installation of the MFG system indicating that the scans are performed at start up, at the time and two hours after taking the oral supplement at home, as it doesn't happen anymore 8 hours without scanning to avoid losing information. After 14 days participants will go to consultation to download MFG data, assess acute response after taking of the supplement in the presence of health personnel (every 15 minutes for 4 hours). Investigators will change the sensor and nutritional supplement to a specific diabetes formula, after 14 days participants will come for MFG data download and to assess acute response after taking the supplement in the presence of healthcare personnel.
The results of the study will allow us to carry out a more appropriate treatment in this profile of patients, which is increasingly prevalent in our consultations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Formula (Fortimel) | Experimental | Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml |
|
| Specific formula for diabetes (Nutrision Advanced) | Experimental | Fats: 46% del VCT (60% monounsaturated fatty acids) Carbohydrates: 31% del VCT Proteins: 21% del VFiber: 2% VCT (80% soluble y 20% insoluble) Density: 1.5kcal/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortimel energy | Other | Standard nutritional oral supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MFG discharge - mean interstitial glucose | Interstitial glucose measured in mg/dl | During 14 days after taking the supplement |
| MFG discharge - hyperglycaemia | hyperglycaemia measured in mg/dl | During 14 days after taking the supplement |
| MFG discharge - hypoglycaemia | hypoglycaemia measured in mg/dl | During 14 days after taking the supplement |
| MFG discharge - GMI | Measured in number of scans per day | During 14 days after taking the supplement |
| MFG discharge - hypoglycaemic events | Measured in number and duration per day | During 14 days after taking the supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glucose intersticial monitoringdiabetes specific supplement | Glucose intersticial measured in mg/dl | During the 4 hours after taking standard formula and the one specific for diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viyey Kishore Doulatram Gamgaram, MD, PhD. | Contact | 951290343 | viyu90@hotmail.es | |
| Gabriel Olveira Fuster, MD, PhD. | Contact | 951290343 | gabrielm.olveira.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Olveira Fuster, MD, PhD. | Hospital Regional Universitario de Málaga - FIMABIS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Universitario de Málaga | Recruiting | Málaga | 29010 | Spain |
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Patients will be assigned in a 1:1 ratio
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| Nutrision Advanced Diason Energy HP |
| Other |
Specifc nutritional oral supplement in diabetics patients |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009748 | Nutrition Disorders |
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