Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT04126759
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generation of predictive algorithms for determining blood glucose levels', 'timeFrame': '12 months', 'description': 'Collected spectral raman data will found the development of predictive algorithms for glucose determination.'}, {'measure': 'Validation of predictive algorithms for determining blood glucose levels', 'timeFrame': '12 months', 'description': 'Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.'}], 'secondaryOutcomes': [{'measure': 'Risk/benefit analysis', 'timeFrame': '12 months', 'description': 'Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects.'}, {'measure': 'Number of encountered Device Deficiencies', 'timeFrame': '12 months', 'description': 'Evaluation of Device Deficiencies with respect to identity, quality, durability or reliability, including malfunctions, use errors and inadequate labeling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-invasive glucose monitoring', 'Raman spectroscopy'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects between 18 and 40 years of age.\n* Diagnosed with type 1 diabetes mellitus.\n* Uses an insulin pen or pump.\n* Hb1Ac \\> 55 mmol/mol at baseline visit.\n* Skin phototype 1-4 according to Fitzpatrick skin tone scale.\n* Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days.\n* Willing to have a peripheral venous catheter inserted.\n* Willing to provide written signed and dated informed consent.\n\nExclusion Criteria:\n\n* Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).\n* Subjects not able to understand and read Danish.\n* Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.\n* Subject is not able to hold hand/arm steadily (including tremors and Parkinson\'s Disease).\n* Reduced circulation in hand. "Allen\'s test" is used for assessing hand circulation to evaluate occurrence of reduced blood.\n* Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.\n* Known allergy to medical grade alcohol.\n* Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin.\n* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject\'s ability to participate\n* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.\n* Diagnosed with cardiovascular diseases.\n* Subjects currently enrolled in another study.\n* Radiotherapy for the past six months.'}, 'identificationModule': {'nctId': 'NCT04126759', 'briefTitle': 'Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'RSP Systems A/S'}, 'officialTitle': 'Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'RSP-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protocol 1', 'description': 'The subjects enrolled in this protocol will dedicate 33 days of home-based measurement and two days for in-clinic measurements. For reference measurements, subjects will be equipped with a BG-meter (Contour Next One, Ascenia). Optical measurements are collected with the IMD. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a BG-meter and two IMD measurements. IMD measurements will be performed using the thenar of the right hand of the subject.', 'interventionNames': ['Device: P0.3']}], 'interventions': [{'name': 'P0.3', 'type': 'DEVICE', 'description': 'Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.', 'armGroupLabels': ['Protocol 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Copenhagen (SDCC)', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Kirsten Nørgaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RSP Systems A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}