Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-03-27 @ 4:25 AM
Study NCT ID:
NCT04166032
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2019-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jenkink@ccf.org', 'phone': '216-445-4791', 'title': 'Kimberly Jenkins, Research Administrator', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'otherDetails': 'Company will review any publication submission within 30 days of estimated due date. If CCF does not hear from company we are to assume we are free to publish. If company identities patentable information they can request for CCF to withhold submission for 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'No adverse events reported', 'eventGroups': [{'id': 'EG000', 'title': 'ANICGM', 'description': 'non-invasive continuous glucose monitoring device\n\nAlertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ANICGM', 'description': 'non-invasive continuous glucose monitoring device\n\nAlertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)'}], 'classes': [{'title': 'Day 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '42.2'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '18.4'}]}]}], 'analyses': [{'pValue': '0.210', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '2 time points taken over 2 separate days respectively, over a span of up to 14 days', 'description': 'Hypothesis is that ANICGM device will perform similarly as other blood glucose monitoring devices Mean absolute relative difference (MARD) is computed by taking the arithmetic mean of the absolute relative differences between the ANICGM system measures and the reference standard FS BG, which serves as the denominator of the calculation. The MARD is expressed as a percentage, and a lower MARD signifies better concordance between the two measurements.', 'unitOfMeasure': 'percentage difference', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ANICGM', 'description': 'non-invasive continuous glucose monitoring device\n\nAlertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ANICGM', 'description': 'non-invasive continuous glucose monitoring device\n\nAlertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-14', 'size': 633525, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-18T11:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2019-11-13', 'resultsFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-12', 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device', 'timeFrame': '2 time points taken over 2 separate days respectively, over a span of up to 14 days', 'description': 'Hypothesis is that ANICGM device will perform similarly as other blood glucose monitoring devices Mean absolute relative difference (MARD) is computed by taking the arithmetic mean of the absolute relative differences between the ANICGM system measures and the reference standard FS BG, which serves as the denominator of the calculation. The MARD is expressed as a percentage, and a lower MARD signifies better concordance between the two measurements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['glucose monitor'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus (DM) affects 30 million people in the United States. To achieve glucose control, most patients are prescribed glucose meters by their physicians. Obtaining glucose levels in this manner necessitates cleaning the fingers, attaching a lancet to a device (or simply using a lancet if a device is not available), pricking the finger with a lancet, placing a drop blood on a strip, and awaiting the readout that results after some chemical reactions. Thereafter, the lancet has to be disposed of in a safe receptacle and the finger has to be blotted to stop the blood from oozing.\n\nThe anxiety, pain, and tedious process have led researchers to develop other means of checking glucose levels. There are now continuous glucose monitoring systems (CGMS) that entail inserting a subcutaneous sensor that sends readings through a transmitter. These CGMs may or may not need calibration with a fingerstick glucose reading, and the subcutaneous sensor still has to be changed every 10 -14 days.\n\nThe Alertgy non-invasive continuous glucose monitor (ANICGM) is a device that does not entail any subcutaneous insertion of a sensor. It is strapped on to the wrist, and glucose readings are given based on subcutaneous signals. In 2001, a non-invasive device called Glucowatch Biographer was introduced that also involved subcutaneous signals without needing a subcutaneous insertion. However, for various reasons such as long calibration period and reading inaccuracies, the product did not take off. The ANICGM is a promising device that might overcome the limitations of existing and previous methods of non-invasive glucose measurement.', 'detailedDescription': "The ANICGM uses a weak electromagnetic field generated by its wrist band sensor to look into the body to produce a spectrum that provides a measurement of blood glucose present in the wrist area of the body. The core sensing technology used is dielectric spectroscopy, and has been shown capable of measuring blood glucose, non-invasively, in a laboratory environment. The system uses proprietary and patented dielectric materials and signal processing to enhance performance in both selectivity and sensitivity for blood glucose measurement.\n\nMuch like how a MRI uses a strong magnetic field and its interaction with the body to create a picture of what is inside, the ANICGM uses a safe weak low frequency radiofrequency field to take a picture of a person's chemical spectrum, some of it specific only to blood glucose.\n\nThe device sends and receives back signals from the wrist area that are used to generate a dielectric spectrum once every 6 seconds. The POC BG using the Accuchek Inform II will be used to provide calibration values for the ANICGM every 5 minutes in mg/dL, during the calibration process. The POC BG levels will be entered into the Alertgy laptop and a proprietary calibration program will be used to analyze the spectral data collected and will generate a calibration algorithm."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes on diet or on pharmacologic treatment for diabetes\n* Hemoglobin A1c between 7.5 - 10.0%\n* Age 18 - 75 years old\n\nExclusion Criteria:\n\n* Patients taking prandial insulin\n* Fasting blood glucose by fingerstick of \\< 70 mg/dL or \\>250 mg/dL\n* Pregnancy\n* End stage renal disease\n* Decompensated or acute heart failure\n* Medications that may cause false readings with glucose meters: acetaminophen, ascorbic acid, dopamine, maltodextrin, mannitol\n* Conditions that limit the ANICGM such as lesions on the forearms\n* Other conditions that the investigator deems will affect the conduct of the study'}, 'identificationModule': {'nctId': 'NCT04166032', 'briefTitle': 'Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor', 'orgStudyIdInfo': {'id': '18-1385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANICGM', 'description': 'non-invasive continuous glucose monitoring device', 'interventionNames': ['Device: Alertgy non-invasive continuous glucose monitoring device (ANICGM)']}], 'interventions': [{'name': 'Alertgy non-invasive continuous glucose monitoring device (ANICGM)', 'type': 'DEVICE', 'description': 'Alertgy non-invasive continuous glucose monitoring device (ANICGM)', 'armGroupLabels': ['ANICGM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alertgy', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Endocrinology Staff Physician', 'investigatorFullName': 'M. Cecilia Lansang, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}