Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT02053051
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nick.oliver@imerial.ac.uk', 'phone': '02075941862', 'title': 'Prof Nick Oliver', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 4 Intervention & Control', 'description': 'Phase 4 Intervention (ABC4D)/Control group over 6 months', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (ABC4D) & RT - CGM', 'description': 'Intervention (ABC4D) \\& Real-time continuous glucose monitoring'}, {'id': 'OG001', 'title': 'Control: Standard Bolus Calculator & RT-CGM', 'description': 'Control: standard bolus calculator \\& Real-time continuous glucose monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-11.5', 'upperLimit': '-4.0'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-10.3', 'upperLimit': '-0.8'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in HbA1c', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Time in Target Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 4 Intervention: ABC4D', 'description': 'ABC4D over 6 months in home setting'}, {'id': 'OG001', 'title': 'Phase 4 Control: Standard Bolus Calculator', 'description': 'Standard bolus calculator for 6 months. real-time cGM in both groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '3.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Difference between baseline and 6-month endpoint.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Time in Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 4 Intervention: ABC4D', 'description': 'ABC4D over 6 months in home setting'}, {'id': 'OG001', 'title': 'Phase 4 Control: Standard Bolus Calculator', 'description': 'Standard bolus calculator for 6 months. real-time cGM in both groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.4'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Difference from baseline to 6-month endpoint.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 4 Intervention (ABC4D) & RT - CGM', 'description': 'Intervention (ABC4D) \\& Real-time continuous glucose monitoring over 6 months'}, {'id': 'FG001', 'title': 'Phase 4 Control: Standard Bolus Calculator & RT-CGM', 'description': 'Control: standard bolus calculator \\& Real-time continuous glucose monitoring over 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From diabetes clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 4: Intervention (ABC4D) & RT - CGM', 'description': 'Intervention (ABC4D) \\& Real-time continuous glucose monitoring over 6 months'}, {'id': 'BG001', 'title': 'Phase 4 Control: Standard Bolus Calculator & RT-CGM', 'description': 'Control: standard bolus calculator \\& Real-time continuous glucose monitoring over 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.6', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '38', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-12', 'size': 3911187, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-12T04:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2014-01-22', 'resultsFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-15', 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in HbA1c'}], 'secondaryOutcomes': [{'measure': 'Percentage Time in Target Range', 'timeFrame': 'Baseline and 6 months', 'description': 'Difference between baseline and 6-month endpoint.'}, {'measure': 'Percentage Time in Hypoglycaemia', 'timeFrame': 'Baseline and 6 months', 'description': 'Difference from baseline to 6-month endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Advanced Bolus Calculator'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27196358', 'type': 'DERIVED', 'citation': 'Reddy M, Pesl P, Xenou M, Toumazou C, Johnston D, Georgiou P, Herrero P, Oliver N. Clinical Safety and Feasibility of the Advanced Bolus Calculator for Type 1 Diabetes Based on Case-Based Reasoning: A 6-Week Nonrandomized Single-Arm Pilot Study. Diabetes Technol Ther. 2016 Aug;18(8):487-93. doi: 10.1089/dia.2015.0413. Epub 2016 May 19.'}], 'seeAlsoLinks': [{'url': 'http://www3.imperial.ac.uk/bioinspiredtechnology/research/metabolic', 'label': 'Our research website'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety and efficacy of a novel advanced bolus calculator in subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm that requires five subject-specific parameters as input to generate a recommended bolus insulin dose:\n\n* current blood glucose (mmol/L)\n* target blood glucose (mmol/L)\n* insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)\n* total grams of carbohydrate in meals\n* insulin sensitivity factor (reduction in glucose per 1 unit of insulin)', 'detailedDescription': 'The Diabetes Technology team at Imperial College have developed a novel advanced bolus calculator. The complete integrated system consists of a commercially available smartphone that holds the novel advanced algorithm. The system requires regular updates of cases derived from retrospective blinded continuous glucose monitoring data and for this a commercially available glucose sensor will be used. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (blood glucose following a meal). The novel decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past.\n\nThe end-product is therefore a subject specific insulin bolus calculator that continues to improve with time. The project utilises commercially available glucose sensors and smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The aim of the ABC4D is to minimise high and low glucose excursions which are associated with the complications of diabetes including blindness, kidney failure, nerve damage and cardiovascular disease.\n\nAn interim analysis was conducted in Phase 4 after 25 participants completed the study (in line with the protocol) and it was agreed to stop the study at this stage. A further protocol amendment was approved by REC/MHRA to commence ABC4D phase 5 (different CT.gov number: NCT03963219).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Diagnosis of T1DM for \\> 1 year\n* On MDI using a basal-bolus insulin regime\n* Structured education in previous 3 years\n* HbA1c ≤ 86mmol/mol\n* No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year\n\nExclusion Criteria:\n\n* Recurrent severe hypoglycaemia\n* Pregnant or planning pregnancy\n* Breastfeeding\n* Enrolled in other clinical trials\n* Have active malignancy or under investigation for malignancy\n* Addison's Disease\n* Gastroparesis\n* Autonomic neuropathy\n* Concomitant use of GLP-1 analogues and gliptins\n* Visual impairment\n* Reduced manual dexterity"}, 'identificationModule': {'nctId': 'NCT02053051', 'acronym': 'ABC4D', 'briefTitle': 'Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Clinical Assessment of an Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)', 'orgStudyIdInfo': {'id': '13SM0091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 4: Intervention (ABC4D)', 'description': 'Advanced Bolus Calculator for Type Diabetes (ABC4D)', 'interventionNames': ['Device: ABC4D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 4 Control: Standard bolus calculator', 'description': 'Standard bolus calculator', 'interventionNames': ['Device: Standard bolus calculator']}], 'interventions': [{'name': 'ABC4D', 'type': 'DEVICE', 'description': 'Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses', 'armGroupLabels': ['Phase 4: Intervention (ABC4D)']}, {'name': 'Standard bolus calculator', 'type': 'DEVICE', 'armGroupLabels': ['Phase 4 Control: Standard bolus calculator']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London, Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Desmond Johnston, F.Med.Sci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}, {'name': 'Nick Oliver, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}, {'name': 'Monika Reddy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This was not part of the approved protocol. Any peer-reviewed publications will be shared with the study participants and will be accessible to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}