Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 2:50 AM
Study NCT ID:
NCT05443204
Status:
UNKNOWN
Last Update Posted:
2022-10-07
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be assigned in a 1:1 ratio'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MFG discharge - mean interstitial glucose', 'timeFrame': 'During 14 days after taking the supplement', 'description': 'Interstitial glucose measured in mg/dl'}, {'measure': 'MFG discharge - hyperglycaemia', 'timeFrame': 'During 14 days after taking the supplement', 'description': 'hyperglycaemia measured in mg/dl'}, {'measure': 'MFG discharge - hypoglycaemia', 'timeFrame': 'During 14 days after taking the supplement', 'description': 'hypoglycaemia measured in mg/dl'}, {'measure': 'MFG discharge - GMI', 'timeFrame': 'During 14 days after taking the supplement', 'description': 'Measured in number of scans per day'}, {'measure': 'MFG discharge - hypoglycaemic events', 'timeFrame': 'During 14 days after taking the supplement', 'description': 'Measured in number and duration per day'}], 'secondaryOutcomes': [{'measure': 'Postprandial glucose intersticial monitoringdiabetes specific supplement', 'timeFrame': 'During the 4 hours after taking standard formula and the one specific for diabetes', 'description': 'Glucose intersticial measured in mg/dl'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes type 2', 'Malnutrition', 'MFG'], 'conditions': ['Diabetes Type 2', 'Malnutrition']}, 'descriptionModule': {'briefSummary': 'Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)', 'detailedDescription': "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.\n\nA 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Patients who do not sign the consent informed.'}, 'identificationModule': {'nctId': 'NCT05443204', 'acronym': 'MFG-SNO', 'briefTitle': 'Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MFG SNO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Formula (Fortimel)', 'description': 'Fats 35% total caloric volume (VCT) Carbohydrates: 49% del VCT Proteins: 16% del VCT Density: 1.5 kcal/ ml', 'interventionNames': ['Other: Fortimel energy']}, {'type': 'EXPERIMENTAL', 'label': 'Specific formula for diabetes (Nutrision Advanced)', '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', 'interventionNames': ['Other: Nutrision Advanced Diason Energy HP']}], 'interventions': [{'name': 'Fortimel energy', 'type': 'OTHER', 'description': 'Standard nutritional oral supplement', 'armGroupLabels': ['Standard Formula (Fortimel)']}, {'name': 'Nutrision Advanced Diason Energy HP', 'type': 'OTHER', 'description': 'Specifc nutritional oral supplement in diabetics patients', 'armGroupLabels': ['Specific formula for diabetes (Nutrision Advanced)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Viyey Kishore Doulatram Gamgaram, MD, PhD', 'role': 'CONTACT', 'email': 'viyu90@hotmail.es', 'phone': '951290343'}, {'name': 'Gabriel Olveira Fuster, MD,PhD', 'role': 'CONTACT', 'email': 'gabrielm.olveira.sspa@juntadeandalucia.es', 'phone': '951290343'}], 'facility': 'Hospital Regional Universitario de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'centralContacts': [{'name': 'Viyey Kishore Doulatram Gamgaram, MD, PhD.', 'role': 'CONTACT', 'email': 'viyu90@hotmail.es', 'phone': '951290343'}, {'name': 'Gabriel Olveira Fuster, MD, PhD.', 'role': 'CONTACT', 'email': 'gabrielm.olveira.sspa@juntadeandalucia.es', 'phone': '951290343'}], 'overallOfficials': [{'name': 'Gabriel Olveira Fuster, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Regional Universitario de Málaga - FIMABIS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}