Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-02 @ 1:32 AM
Study NCT ID:
NCT04060732
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2019-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe hypoglycemia rate', 'timeFrame': '12 months', 'description': 'Frequency (number) of serious episodes of hypoglycemia (as defined by the American Diabetes Association, as severe cognitive impairment requiring external assistance for recovery).'}, {'measure': 'Severe hypoglycemia rate', 'timeFrame': '12 months', 'description': 'Percentage (%) of patients with at least 1 episode of severe hypoglycemia.'}], 'secondaryOutcomes': [{'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'HbA1c (mmol/mol) change from baseline.'}, {'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'Time in hypoglycemia (\\<3.9 mmol/L) at any time of day.'}, {'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'Time spent with hypoglycemia (\\<3.1 mmol/L) at any time of day.'}, {'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'Time spent with hypoglycemia (\\<2.2 mmol/L) at any time of day.'}, {'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'Time spent within the euglycemic range (3.9 - 9.9 mmol/L) at any time of day.'}, {'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'Time spent with hyperglycemia (\\>10 mmol/L)at any time of day.'}, {'measure': 'Glucose control', 'timeFrame': '12 months', 'description': 'Time spent in hyperglycemia (\\>13.3 mmol/L) at any time of day.'}, {'measure': 'Flash Glucose Monitoring treatment satisfaction', 'timeFrame': '12 months', 'description': 'Change in Diabetes Quality Of Life- DQOL score from baseline.\n\nThe original DQOL is a 60-item instrument to assess the diabetes-related QOL of participants. The instrument provides an overall scale score, as well as four subscale scores for 1) satisfaction with treatment, 2) impact of treatment, 3) worry about the future effects of diabetes, and 4) worry about social/vocational issues.\n\nItems are scored on a 5-point Likert scale and are of two general formats. One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment and provides response options from 1 (never) to 5 (all the time). The second format asks about satisfaction with treatment and quality of life and is scored from 1 (very satisfied) to 5 (very dissatisfied).\n\nHigher scores on DQOL items and subscales are, therefore, negatively valenced, indicating problem frequency or dissatisfaction.'}, {'measure': 'Safety of the device', 'timeFrame': '12 months', 'description': 'Number (n) of allergic patch reactions.'}, {'measure': 'Feasibility of the device', 'timeFrame': '12 months', 'description': 'Number (n) of untimely detachments of the device.'}, {'measure': 'Feasibility of the device', 'timeFrame': '12 months', 'description': 'Percentage (%) of recorded data by the device.'}, {'measure': 'Feasibility of the device', 'timeFrame': '12 months', 'description': 'Number (n) of device interruptions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flash Glucose Monitoring', 'Glucose Monitoring', 'Diabetes Mellitus Type 1'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '8366922', 'type': 'BACKGROUND', 'citation': 'Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.'}, {'pmid': '27979893', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. 6. Glycemic Targets. Diabetes Care. 2017 Jan;40(Suppl 1):S48-S56. doi: 10.2337/dc17-S009. No abstract available.'}, {'pmid': '23378621', 'type': 'BACKGROUND', 'citation': 'Miller KM, Beck RW, Bergenstal RM, Goland RS, Haller MJ, McGill JB, Rodriguez H, Simmons JH, Hirsch IB; T1D Exchange Clinic Network. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013 Jul;36(7):2009-14. doi: 10.2337/dc12-1770. Epub 2013 Feb 1.'}, {'pmid': '24876543', 'type': 'BACKGROUND', 'citation': 'Hoss U, Budiman ES, Liu H, Christiansen MP. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. doi: 10.1177/1932296813511747. Epub 2014 Jan 1.'}, {'pmid': '26171659', 'type': 'BACKGROUND', 'citation': 'Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. doi: 10.1089/dia.2014.0378. Epub 2015 Jul 14.'}, {'pmid': '25661981', 'type': 'BACKGROUND', 'citation': 'New JP, Ajjan R, Pfeiffer AF, Freckmann G. Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS). Diabet Med. 2015 May;32(5):609-17. doi: 10.1111/dme.12713. Epub 2015 Feb 20.'}, {'pmid': '27287421', 'type': 'BACKGROUND', 'citation': 'Bonora B, Maran A, Ciciliot S, Avogaro A, Fadini GP. Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes. J Endocrinol Invest. 2016 Dec;39(12):1391-1399. doi: 10.1007/s40618-016-0495-8. Epub 2016 Jun 10.'}, {'pmid': '38833007', 'type': 'DERIVED', 'citation': 'Dei Cas A, Aldigeri R, Bellei G, Raffaeli D, Di Bartolo P, Sforza A, Marchesini G, Ciardullo AV, Manicardi V, Bianco M, Monesi M, Vacirca A, Cimicchi MC, Sordillo PA, Altini M, Fantuzzi F, Bonadonna RC; Flash-glucose monitoring Emilia Romagna Regional network. Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications. Acta Diabetol. 2024 Sep;61(9):1177-1184. doi: 10.1007/s00592-024-02298-x. Epub 2024 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease.\n\nSelf-monitoring of blood glucose (SMBG) in type 1 diabetes (T1D) is mandatory to implement safe and effective adjustments in insulin therapy in order to reduce glucose levels and prevent hypoglycemic episodes. It is known that a higher rate of glucose testing (up to 8 times/day) is associated with improved glucose control, however, long-term repeated daily glucose tests are painful, inconvenient and difficult to pursue.\n\nContinuous glucose monitoring (CGM) is an alternative to SMBG, but the use of conventional CGM has been limited by the need of repeated calibration using capillary glucose testing, relatively short sensor lifespan and high costs. The recently introduced CGM FreeStyle Libre™ (Abbott Diabetes Care, Witney, UK) flash glucose monitoring (FGM), a new generation of glucose testing device, has the advantage to be user friendly by just scanning the reader over the sensor.\n\nThe FGM system does not require calibration, has a long sensor lifetime of 14 days and it\'s relatively affordable, explaining the widespread use of the device.\n\nThe Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" as it is not equipped with alarms capable of alerting the patient to cut-off value for the hypo- or hyperglycemia, but allows the glycemic trend to be viewed at request.', 'detailedDescription': 'Patients will be identified and enrolled in the Diabetes Departments of different hospitals/clinics in the Emilia Romagna region, Italy. Patients will be divided in two groups A (naive patients,) and B (patients already using the device at enrollment) and followed for 12 months.\n\nStudy design is observational prospective and includes 3-months follow up visits until the 12-month final evaluation.\n\nAt each visit, patient clinical data, adherence and side effects will be recorded and data download from the device will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis of Diabetes Mellitus type 1 for at least 12 months and in multi-injection insulin therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus type 1 for at least 12 months\n* Multi-injection insulin therapy\n* C-peptide \\<0.2 nmol/L\n* At least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement).\n\nExclusion Criteria:\n\n* Diabetes Mellitus type 2\n* Other types of diabetes\n* Other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system.'}, 'identificationModule': {'nctId': 'NCT04060732', 'briefTitle': 'Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Parma'}, 'officialTitle': 'Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.', 'orgStudyIdInfo': {'id': '44771'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Flash Glucose Monitoring Device', 'description': 'The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" used by Diabetes Mellitus type 1 patients.', 'interventionNames': ['Device: Flash Glucose Monitoring-FGM']}], 'interventions': [{'name': 'Flash Glucose Monitoring-FGM', 'type': 'DEVICE', 'description': 'The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" will be assigned to the enrolled patients at baseline until the end of follow-up after 12 months.', 'armGroupLabels': ['Flash Glucose Monitoring Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Riccardo Bonadonna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regione Emilia-Romagna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regione Emilia-Romagna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Endocrinology and Metabolic disease Unit', 'investigatorFullName': 'Riccardo Bonadonna', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Parma'}}}}