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

Primary Purpose

Diabetes Type 2, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fortimel energy
Nutrision Advanced Diason Energy HP
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring Diabetes type 2, Malnutrition, MFG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Regional Universitario de MálagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard Formula (Fortimel)

Specific formula for diabetes (Nutrision Advanced)

Arm Description

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

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

Outcomes

Primary Outcome Measures

MFG discharge - mean interstitial glucose
Interstitial glucose measured in mg/dl
MFG discharge - hyperglycaemia
hyperglycaemia measured in mg/dl
MFG discharge - hypoglycaemia
hypoglycaemia measured in mg/dl
MFG discharge - GMI
Measured in number of scans per day
MFG discharge - hypoglycaemic events
Measured in number and duration per day

Secondary Outcome Measures

Postprandial glucose intersticial monitoringdiabetes specific supplement
Glucose intersticial measured in mg/dl

Full Information

First Posted
June 29, 2022
Last Updated
October 6, 2022
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05443204
Brief Title
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, Malnutrition
Keywords
Diabetes type 2, Malnutrition, MFG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned in a 1:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Formula (Fortimel)
Arm Type
Experimental
Arm Description
Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml
Arm Title
Specific formula for diabetes (Nutrision Advanced)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Fortimel energy
Intervention Description
Standard nutritional oral supplement
Intervention Type
Other
Intervention Name(s)
Nutrision Advanced Diason Energy HP
Intervention Description
Specifc nutritional oral supplement in diabetics patients
Primary Outcome Measure Information:
Title
MFG discharge - mean interstitial glucose
Description
Interstitial glucose measured in mg/dl
Time Frame
During 14 days after taking the supplement
Title
MFG discharge - hyperglycaemia
Description
hyperglycaemia measured in mg/dl
Time Frame
During 14 days after taking the supplement
Title
MFG discharge - hypoglycaemia
Description
hypoglycaemia measured in mg/dl
Time Frame
During 14 days after taking the supplement
Title
MFG discharge - GMI
Description
Measured in number of scans per day
Time Frame
During 14 days after taking the supplement
Title
MFG discharge - hypoglycaemic events
Description
Measured in number and duration per day
Time Frame
During 14 days after taking the supplement
Secondary Outcome Measure Information:
Title
Postprandial glucose intersticial monitoringdiabetes specific supplement
Description
Glucose intersticial measured in mg/dl
Time Frame
During the 4 hours after taking standard formula and the one specific for diabetes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viyey Kishore Doulatram Gamgaram, MD, PhD.
Phone
951290343
Email
viyu90@hotmail.es
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Olveira Fuster, MD, PhD.
Phone
951290343
Email
gabrielm.olveira.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira Fuster, MD, PhD.
Organizational Affiliation
Hospital Regional Universitario de Málaga - FIMABIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viyey Kishore Doulatram Gamgaram, MD, PhD
Phone
951290343
Email
viyu90@hotmail.es
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira Fuster, MD,PhD
Phone
951290343
Email
gabrielm.olveira.sspa@juntadeandalucia.es

12. IPD Sharing Statement

Learn more about this trial

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

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