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

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

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

Study Overview

• Status: Recruiting
• Conditions: Malnutrition; Diabetes Type 2
• Intervention / Treatment: Other: Fortimel energy; Other: Nutrision Advanced Diason Energy HP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viyey Kishore Doulatram Gamgaram, MD, PhD.; Phone Number: 951290343; Email: viyu90@hotmail.es
• Study Contact Backup: Name: Gabriel Olveira Fuster, MD, PhD.; Phone Number: 951290343; Email: gabrielm.olveira.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Malaga
    • Contact: Viyey Kishore Doulatram Gamgaram, MD, PhD; Phone Number: 951290343; Email: viyu90@hotmail.es
    • Contact: Gabriel Olveira Fuster, MD,PhD; Phone Number: 951290343; Email: gabrielm.olveira.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Investigators: Principal Investigator: Gabriel Olveira Fuster, MD, PhD., Hospital Regional Universitario de Málaga - FIMABIS

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Malnutrition; Diabetes type 2; MFG
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Malnutrition
• Other Study ID Numbers: MFG SNO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No