Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT05460260
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucomen Day Cascade CGM System 21-Day Wear Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '21-Day CGM Functionality The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days.', 'timeFrame': '21 Days', 'description': 'To evaluate the feasibility of a 21-day wear CGM system.\n\nThe secondary objective is:\n\n-To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days.\n\nTo evaluate the feasibility of a 21-day wear CGM system.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Uniformity', 'timeFrame': 'From 15 to 21 days', 'description': 'To evaluate the uniformity of the performance of the WaveForm GlucoMen Day Cascade CGM over 21 days.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Efficacy of a 21-Day Wear Period for the Cascade CGM']}, 'descriptionModule': {'briefSummary': 'Assessment of 21-day CGM wear period', 'detailedDescription': 'This single-site study will include 10 subjects who will wear two CGMs for 21 days. On day 1, 5, 10, 15, and 21 subjects will be in-clinic for 12 hrs of testing with YSI blood glucose measurements taken every 15 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with Type I and Type II Diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months\n\n * 18 years of age or older\n * Currently self-monitoring capillary blood glucose (on average at least three times per day or more) or on a CGM for at least three months\n * Be willing to have blood glucose levels manipulated into high and low glucose levels during in clinic days if deemed appropriate per the protocol based on insulin use.\n * Willing to follow all study procedures, including attending all clinic visits during which a venous line will be inserted for blood sampling, wearing CGM sensors for entire study, performing fingertip glucose tests for self-monitoring and calibration, and keeping a diary of activities.\n * Be willing to wear two investigational CGM devices.\n * Sign informed consent form\n\nExclusion Criteria:\n\n* • Known allergy to medical grade adhesives\n\n * Magnetic Resonance Imaging (MRI) scheduled during CGM sensor wear period\n * Persons with type 2 diabetes using diet and exercise only for diabetes management\n * Used an investigational drug within 30 days prior to study entry\n * Hematocrit \\< 32% (obtained during screening)\n * Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal\n * Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g., percutaneous transluminal coronary angioplasty \\[PTCA\\], stent placement), or coronary artery bypass graft (CABG) within the past six months\n * Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis\n * Cerebrovascular incident within the past six months\n * History or presence of eczema, psoriasis, atopic or contact dermatitis\n * Pregnancy at the start of the study.\n * Current use or within one-week exposure to topical medications at the proposed insertion sites\n * Seizure disorder (epilepsy)\n * Malignancy within the past five years, except basal cell or squamous cell skin cancers\n * Major surgical operation within 30 days prior to screening\n * Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity (reason for exclusion will be clearly documented by investigator or designee)'}, 'identificationModule': {'nctId': 'NCT05460260', 'acronym': 'GLUCODAY21', 'briefTitle': 'Glucomen Day Cascade CGM System 21-Day Wear Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'WaveForm Technologies Inc.'}, 'officialTitle': 'GlucoMen Day Cascade CGM 21-Day Study', 'orgStudyIdInfo': {'id': 'PR-19-0037'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GLUCODAY21', 'description': 'Study subjects for 21-day study', 'interventionNames': ['Device: Cascade CGM']}], 'interventions': [{'name': 'Cascade CGM', 'type': 'DEVICE', 'description': '21-days of CGM wear', 'armGroupLabels': ['GLUCODAY21']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Clinical Hospital "Sveti Duh"', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Novo Mesto', 'country': 'Slovenia', 'facility': 'Miremo, d.o.o', 'geoPoint': {'lat': 45.80397, 'lon': 15.16886}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WaveForm Technologies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}