Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 4:36 AM
Study NCT ID:
NCT07052292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
User Experience With DuraTouch® in Patients With Type 1 or Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant rating the ease of use, convenience and satisfaction with the device', 'timeFrame': 'At week 12', 'description': 'Rating score on a 5-point Likert-type response scale. 1=Not at all easy/convenient/satisfied, 5=Extremely easy/convenient/satisfied.'}], 'secondaryOutcomes': [{'measure': 'Participant rating the ease of preparing the device for use and ease of injection', 'timeFrame': 'At week 12', 'description': 'Rating score on a 5-point Likert-type response scale. 1=Not at all easy, 5=Extremely easy.'}, {'measure': 'Participant rating the confidence of using the device correctly and confidence in the device delivering the correct full dose', 'timeFrame': 'At week 12', 'description': 'Rating score on a 5-point Likert-type response scale. 1=Not at all confident, 5=Extremely confident.'}, {'measure': 'Participant rating ease to learn how to use the device', 'timeFrame': 'At week 12', 'description': 'Rating score on a 5-point Likert-type response scale. 1=Very difficult, 5=Very Easy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study looks at overall impact of the use of DuraTouch® in terms of ease, convenience to use and satisfaction in participants with either type 1 or type 2 diabetes.The study will last for about 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population included participants with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) who require insulin injection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The decision to initiate treatment with DuraTouch® has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.\n* All needed signed consent(s) are obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study.\n* Mental incapacity (when no caregiver and LAR are assigned to the patient), unwillingness or language barriers precluding adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT07052292', 'briefTitle': 'User Experience With DuraTouch® in Patients With Type 1 or Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'DuraTouch® - Post-Market Clinical Follow-up (PMCF) Study in a Real-world Setting', 'orgStudyIdInfo': {'id': 'NN1250-8353'}, 'secondaryIdInfos': [{'id': 'U1111-1316-4217', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'DuraTouch® (Insulin injection)', 'description': 'Participants will subcutaneously inject the insulin prescribed by the doctor using DuraTouch® according to routine clinical practice at the discretion of the treating physician.', 'interventionNames': ['Device: DuraTouch®']}], 'interventions': [{'name': 'DuraTouch®', 'type': 'DEVICE', 'description': 'Participants will subcutaneously inject the insulin using DuraTouch®.', 'armGroupLabels': ['DuraTouch® (Insulin injection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-414', 'city': 'Wroclaw', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Ginemedica Sp. z o.o. Sp.k'}, {'zip': '31-530', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'CenterMed Krakow Sp. z o.o.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '59-300', 'city': 'Lubin', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Diabetolog praktyka lekarska - Bartosz Bednarkiewicz', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '20-718', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'country': 'Poland', 'facility': 'Centrum Medyczne Ekamed sp. z o.o.', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '65-034', 'city': 'Zielona Góra', 'state': 'Lubusz Voivodeship', 'country': 'Poland', 'facility': 'Gabinet Lekarski Internistyczny Iwona Towpik', 'geoPoint': {'lat': 51.93548, 'lon': 15.50643}}, {'zip': '02-507', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji - Klinika Chorob Wewnetrznych, Endokrynologii i Diab', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '48-300', 'city': 'Nysa', 'state': 'Opole Voivodeship', 'country': 'Poland', 'facility': 'Diabetica sp. z o.o.', 'geoPoint': {'lat': 50.47379, 'lon': 17.33437}}, {'zip': '15-404', 'city': 'Bialystok', 'state': 'Podlaskie Voivodeship', 'country': 'Poland', 'facility': 'Poradnia Diabetologiczna. Niepubliczny Zaklad Opieki Zdrowotnej Lege Artis', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-858', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '90-302', 'city': 'Lodz', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': '"Santa Familia PTG tódz'}, {'zip': '41-500', 'city': 'Chorzów', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Diab Serwis POPENDA Spólka Jawna', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}