Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-27 @ 12:33 AM
Study NCT ID:
NCT05904769
Status:
TERMINATED
Last Update Posted:
2025-10-08
First Post:
2023-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kowlgi.NarayanGurukripa@mayo.edu', 'phone': '507-422-0549', 'title': 'Guru Kowlgi M.B.B.S., M.S.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to lack of staffing support.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of informed consent through the end of study completion, approximately 24 hours.', 'description': 'Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.', 'eventGroups': [{'id': 'EG000', 'title': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}, {'id': 'OG001', 'title': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.08', 'spread': '17.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Difference in measurement of Systolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.'}, {'type': 'PRIMARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}, {'id': 'OG001', 'title': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.42', 'spread': '10.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Difference in measurement of Diastolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.'}, {'type': 'PRIMARY', 'title': 'Blood Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}, {'id': 'OG001', 'title': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure who do not receive daily blood sugar checks wore the LIFELEAF Smartwatch for the duration of the procedure.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}], 'timeFrame': 'Baseline', 'description': 'The difference in measurement of blood glucose levels using the wrist-based PPG sensor versus standard blood-based measurement measured in milligrams per deciliter (mg/dL) in subjects who had standard of care blood glucose monitoring done. Only subjects who are hospitalized and diabetic per standard of care receive standard of care blood-based glucose monitoring.', 'reportingStatus': 'POSTED', 'populationDescription': "0 subjects enrolled in the hospitalized diabetic arm as study was terminated early (lack of staffing support). Data not collected for this outcome measure in the EP group as it didn't apply to the EP arm. Standard blood-based glucose measurements were only measured on subjects that were diabetic + hospitalized. EP subjects were not hospitalized; due to this standard blood glucose was not monitored in this group therefore a comparison couldn't be made to the PPG sensor blood glucose measurements."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}, {'id': 'FG001', 'title': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}, {'id': 'BG001', 'title': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure.\n\nLIFELEAF Smartwatch: Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.3', 'spread': '10.24', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '10.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG001'}, {'value': '60', '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 States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-10', 'size': 592215, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-23T14:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'whyStopped': 'Lack of staffing support', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2025-04-30', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-06-06', 'resultsFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2023-06-06', 'dispFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-19', 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline', 'description': 'Difference in measurement of Systolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline', 'description': 'Difference in measurement of Diastolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).'}, {'measure': 'Blood Glucose Level', 'timeFrame': 'Baseline', 'description': 'The difference in measurement of blood glucose levels using the wrist-based PPG sensor versus standard blood-based measurement measured in milligrams per deciliter (mg/dL) in subjects who had standard of care blood glucose monitoring done. Only subjects who are hospitalized and diabetic per standard of care receive standard of care blood-based glucose monitoring.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare blood glucose, blood pressure and electrocardiogram (ECG) readings on the LIFELEAF Smartwatch compared to standard methods of measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care.\n* Patients undergoing continuous monitoring for heart rate, ECG and blood pressure as part of their routine care.\n* Patients undergoing invasive and noninvasive electrophysiologic procedures.\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent.\n* Patients without arms as these are needed to wear the wrist-based sensor.'}, 'identificationModule': {'nctId': 'NCT05904769', 'briefTitle': 'A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Non-invasive Measurement of Blood Glucose, Blood Pressure and Extrapolation of QRS Complex Using a Wrist Wearable Photoplethysmography Sensor', 'orgStudyIdInfo': {'id': '22-010799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hospitalized Diabetic Group', 'description': 'Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, will wear the LIFELEAF Smartwatch for the duration of their hospital stay.', 'interventionNames': ['Device: LIFELEAF Smartwatch']}, {'type': 'EXPERIMENTAL', 'label': 'Electrophysiologic (EP) Group', 'description': 'Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.', 'interventionNames': ['Device: LIFELEAF Smartwatch']}], 'interventions': [{'name': 'LIFELEAF Smartwatch', 'type': 'DEVICE', 'description': 'Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.', 'armGroupLabels': ['Electrophysiologic (EP) Group', 'Hospitalized Diabetic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Narayan Guru G. Kowlgi, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Narayan (Guru) G. Kowlgi', 'investigatorAffiliation': 'Mayo Clinic'}}}}