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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

Tracking Information
First Submitted Date  ICMJE June 29, 2022
First Posted Date  ICMJE July 5, 2022
Last Update Posted Date October 7, 2022
Actual Study Start Date  ICMJE July 7, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2022)
  • MFG discharge - mean interstitial glucose [ Time Frame: During 14 days after taking the supplement ]
    Interstitial glucose measured in mg/dl
  • MFG discharge - hyperglycaemia [ Time Frame: During 14 days after taking the supplement ]
    hyperglycaemia measured in mg/dl
  • MFG discharge - hypoglycaemia [ Time Frame: During 14 days after taking the supplement ]
    hypoglycaemia measured in mg/dl
  • MFG discharge - GMI [ Time Frame: During 14 days after taking the supplement ]
    Measured in number of scans per day
  • MFG discharge - hypoglycaemic events [ Time Frame: During 14 days after taking the supplement ]
    Measured in number and duration per day
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2022)		 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Diabetes Type 2
  • Malnutrition
Intervention  ICMJE
  • Other: Fortimel energy
    Standard nutritional oral supplement
  • Other: Nutrision Advanced Diason Energy HP
    Specifc nutritional oral supplement in diabetics patients
Study Arms  ICMJE
  • Experimental: Standard Formula (Fortimel)
    Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml
    Intervention: Other: Fortimel energy
  • 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
    Intervention: Other: Nutrision Advanced Diason Energy HP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2022)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Viyey Kishore Doulatram Gamgaram, MD, PhD. 951290343 viyu90@hotmail.es
Contact: Gabriel Olveira Fuster, MD, PhD. 951290343 gabrielm.olveira.sspa@juntadeandalucia.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05443204
Other Study ID Numbers  ICMJE MFG SNO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabriel Olveira Fuster, MD, PhD. Hospital Regional Universitario de Málaga - FIMABIS
PRS Account Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP