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

Malnutrition Clinical Trial

— MFG-SNO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443204
• Other study ID #: MFG SNO
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: Viyey Kishore Doulatram Gamgaram, MD, PhD.
• Phone: 951290343
• Email: viyu90[@]hotmail.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Malnutrition

Intervention

Other:
• Fortimel energy
Standard nutritional oral supplement
• Nutrision Advanced Diason Energy HP
Specifc nutritional oral supplement in diabetics patients

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MFG discharge - mean interstitial glucose	Interstitial glucose measured in mg/dl	During 14 days after taking the supplement
Primary	MFG discharge - hyperglycaemia	hyperglycaemia measured in mg/dl	During 14 days after taking the supplement
Primary	MFG discharge - hypoglycaemia	hypoglycaemia measured in mg/dl	During 14 days after taking the supplement
Primary	MFG discharge - GMI	Measured in number of scans per day	During 14 days after taking the supplement
Primary	MFG discharge - hypoglycaemic events	Measured in number and duration per day	During 14 days after taking the supplement
Secondary	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