Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes and Oral Supplements: Standard Formula vs Specific Formula for Diabetes

Conditions
-----------------
Diabetes Type 2, Malnutrition

Intervention / Treatment
-----------------
* Other: Fortimel energy
* Other: Nutrision Advanced Diason Energy HP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with DM2 under follow-up by the Clinical Nutrition and Dietetics Unit (UNCYD) who present malnutrition or are at risk of malnutrition and require oral nutritional supplements, for a minimum estimated period of 3 months. Exclusion Criteria: Patients with DM1, steroid diabetes, pancreatic diabetes, DM2 treated with rapid insulin, glomerular filtration rate less than 30 mL/min/1.73m2, intolerance to the product, gastrectomy or gastroparesis. Patients who do not sign the consent informed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be assigned in a 1:1 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Formula (Fortimel)<br>Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml | Other: Fortimel energy<br>* Standard nutritional oral supplement<br>|
| Experimental: Specific formula for diabetes (Nutrision Advanced)<br>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 | Other: Nutrision Advanced Diason Energy HP<br>* Specifc nutritional oral supplement in diabetics patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes type 2, Malnutrition, MFG