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

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ClinicalTrials.gov Identifier: NCT05443204
Recruitment Status : Recruiting
First Posted : July 5, 2022
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Malnutrition Other: Fortimel energy Other: Nutrision Advanced Diason Energy HP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned in a 1:1 ratio
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. MFG discharge - mean interstitial glucose [ Time Frame: During 14 days after taking the supplement ]
    Interstitial glucose measured in mg/dl

  2. MFG discharge - hyperglycaemia [ Time Frame: During 14 days after taking the supplement ]
    hyperglycaemia measured in mg/dl

  3. MFG discharge - hypoglycaemia [ Time Frame: During 14 days after taking the supplement ]
    hypoglycaemia measured in mg/dl

  4. MFG discharge - GMI [ Time Frame: During 14 days after taking the supplement ]
    Measured in number of scans per day

  5. MFG discharge - hypoglycaemic events [ Time Frame: During 14 days after taking the supplement ]
    Measured in number and duration per day


Secondary Outcome Measures :
  1. Postprandial glucose intersticial monitoringdiabetes specific supplement [ Time Frame: During the 4 hours after taking standard formula and the one specific for diabetes ]
    Glucose intersticial measured in mg/dl


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05443204


Contacts
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Contact: Viyey Kishore Doulatram Gamgaram, MD, PhD. 951290343 viyu90@hotmail.es
Contact: Gabriel Olveira Fuster, MD, PhD. 951290343 gabrielm.olveira.sspa@juntadeandalucia.es

Locations
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Spain
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain, 29010
Contact: Viyey Kishore Doulatram Gamgaram, MD, PhD    951290343    viyu90@hotmail.es   
Contact: Gabriel Olveira Fuster, MD,PhD    951290343    gabrielm.olveira.sspa@juntadeandalucia.es   
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Principal Investigator: Gabriel Olveira Fuster, MD, PhD. Hospital Regional Universitario de Málaga - FIMABIS
More Information
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT05443204    
Other Study ID Numbers: MFG SNO
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Diabetes type 2
Malnutrition
MFG
Additional relevant MeSH terms:
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Diabetes Mellitus
Malnutrition
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders