Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT05633628
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2022-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'change at week 16', 'description': 'mmol/mol'}], 'secondaryOutcomes': [{'measure': 'Percentage of time spent in range (Glucose)', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': '3.9-10 mmol/l as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Percentage time spent in hyperglycaemia', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': '\\> 10 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Percentage time spent in hypoglycaemia', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': '\\< 3.9 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Average glucose value', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Standard deviation for glucose value', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'SD as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Percentage time in euglycemia, time in target', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': '3.9-8.0 mmol/L as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Number of hyperglycemic episodes per day', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Number of hyperglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Number of hypoglycemic episodes per day', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Number of hypoglycemic episodes per day as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Data availability in % of all time', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Data availability in % of all time as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Postprandial peak during 2 hours for breakfast, lunch and dinner.', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Postprandial peak during 2 hours for breakfast, lunch and dinner as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Night-time insulin effect', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Night-time insulin effect as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'Fasting glucose level', 'timeFrame': 'change first 28 days in the study compared with the last 28 days', 'description': 'Fasting glucose level as analyzed by OneTwo Analytics CE marked Decision support Clinic'}, {'measure': 'The Diabetes Treatment Satisfaction questionnaire', 'timeFrame': 'change at week 16', 'description': 'Includes eight items related to the diabetes treatment over the past weeks.'}, {'measure': 'WHO-5 Well-Being Index', 'timeFrame': 'change at week 16', 'description': 'Brief well-being questionnaire with five items in relation to previous 2 weeks'}, {'measure': 'The Patient Preferences for Patient Participation (4Ps)', 'timeFrame': 'change at week 16', 'description': 'The 4Ps is a questionnaire including 12 items comprising patient´s preferences as well as experiences.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CGM', 'Personcentered care'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.', 'detailedDescription': "This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.\n\nPeriodic CGM group- Intervention group:\n\nThe participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.\n\nSelf-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-80 years\n* Type 2 diabetes with a duration of \\> 6 months\n* HbA1c 45-70 mmol/mol\n* Have a smartphone\n* Experience of self-monitoring of blood glucose prior to the study start\n\nExclusion Criteria:\n\n* Prandial insulin\n* Pregnancy or planning pregnancy during the study\n* Breastfeeding\n* Renal disease with estimated glomerular filtration rate (eGFR) \\<45 mL/ min/1.73 m2\n* Active malignancy or under investigation for malignancy\n* Severe visual impairment\n* Severe skin allergy that inhibits the use of a continuous glucose monitoring device\n* Glucocorticoids (systemic)\n* Planned or currently using weight reduction medications, programs, or surgery\n* Cognitively or psychologically unable to participate and read instructions\n* Enrolled in other clinical trials\n* Eating disorders'}, 'identificationModule': {'nctId': 'NCT05633628', 'briefTitle': 'Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sophiahemmet University'}, 'officialTitle': 'Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'Periodic Glucose Insights'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Periodic CGM- Intervention group', 'description': "The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-management care of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.", 'interventionNames': ['Behavioral: Periodic CGM group with data analysis report- Intervention group']}, {'type': 'NO_INTERVENTION', 'label': 'Self-monitoring of blood glucose, SMBG and usual care - Control Group', 'description': 'The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.'}], 'interventions': [{'name': 'Periodic CGM group with data analysis report- Intervention group', 'type': 'BEHAVIORAL', 'description': "The patients are also instructed to continue to perform SMBG by finger prick if they experience symptoms of hypo- or hyperglycemia. During visit 0 (baseline) the patients is also instructed about how they can log in to the National Diabetes Register (NDR) to access their own NDR's recorded data and use the diabetes questionnaire.", 'armGroupLabels': ['Periodic CGM- Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Unn-Britt Johansson, PhD', 'role': 'CONTACT'}], 'facility': 'Sophiahemmet University', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Unn-Britt Johanssson, Professor', 'role': 'CONTACT', 'email': 'unn-britt.johansson@shh.se', 'phone': '+4684062902'}], 'overallOfficials': [{'name': 'Unn-Britt Johansson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sophiahemmet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sophiahemmet University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Diabetes Foundation', 'class': 'UNKNOWN'}, {'name': 'OneTwo Analytics AB', 'class': 'UNKNOWN'}, {'name': 'Sophiahemmet', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor', 'investigatorFullName': 'Unn-Britt Johansson', 'investigatorAffiliation': 'Sophiahemmet University'}}}}