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

NCT ID: NCT05443204

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2023-05-31

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.

Conditions

Diabetes Type 2; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Formula (Fortimel)

Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml

Group Type: EXPERIMENTAL

Fortimel energy

Intervention Type: OTHER

Standard nutritional oral supplement

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

Group Type: EXPERIMENTAL

Nutrision Advanced Diason Energy HP

Intervention Type: OTHER

Specifc nutritional oral supplement in diabetics patients

Interventions

Fortimel energy

Standard nutritional oral supplement

Intervention Type: OTHER

Nutrision Advanced Diason Energy HP

Specifc nutritional oral supplement in diabetics patients

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Olveira Fuster, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga - FIMABIS

Locations

Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Viyey Kishore Doulatram Gamgaram, MD, PhD.

Role: CONTACT

viyu90@hotmail.es

951290343

Gabriel Olveira Fuster, MD, PhD.

Role: CONTACT

gabrielm.olveira.sspa@juntadeandalucia.es

951290343

Facility Contacts

Viyey Kishore Doulatram Gamgaram, MD, PhD

Role: primary

viyu90@hotmail.es

951290343

Gabriel Olveira Fuster, MD,PhD

Role: backup

gabrielm.olveira.sspa@juntadeandalucia.es

951290343

Other Identifiers

MFG SNO

Identifier Type: -

Identifier Source: org_study_id