Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes
MFG-SNO
1 other identifier
interventional
30
1 country
1
Brief Summary
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedOctober 7, 2022
May 1, 2022
6 months
June 29, 2022
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
MFG discharge - mean interstitial glucose
Interstitial glucose measured in mg/dl
During 14 days after taking the supplement
MFG discharge - hyperglycaemia
hyperglycaemia measured in mg/dl
During 14 days after taking the supplement
MFG discharge - hypoglycaemia
hypoglycaemia measured in mg/dl
During 14 days after taking the supplement
MFG discharge - GMI
Measured in number of scans per day
During 14 days after taking the supplement
MFG discharge - hypoglycaemic events
Measured in number and duration per day
During 14 days after taking the supplement
Secondary Outcomes (1)
Postprandial glucose intersticial monitoringdiabetes specific supplement
During the 4 hours after taking standard formula and the one specific for diabetes
Study Arms (2)
Standard Formula (Fortimel)
EXPERIMENTALFats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml
Specific formula for diabetes (Nutrision Advanced)
EXPERIMENTALFats: 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
Interventions
Specifc nutritional oral supplement in diabetics patients
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Olveira Fuster, MD, PhD.
Hospital Regional Universitario de Málaga - FIMABIS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2022
First Posted
July 5, 2022
Study Start
July 7, 2022
Primary Completion
December 31, 2022
Study Completion
May 31, 2023
Last Updated
October 7, 2022
Record last verified: 2022-05