Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 1:40 AM
Study NCT ID:
NCT07377266
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-29
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental diabetes-related quality of life (T1DAL)', 'timeFrame': 'From baseline to study end after one year', 'description': 'Change in Parental diabetes-related quality of life, measured by the questionnaire T1DAL in Danish. An increase in score indicates an improvement in parental diabetes-related quality of life.'}, {'measure': "Children's perception of clinical visits (MyHospitalVoice)", 'timeFrame': 'From baseline to study end after one year', 'description': "Change in Children's perception of clinical visits, measured by the questionnaire MyHospitalVoice in Danish. An increase in score indicates an improvement in perception of clinical visits-"}], 'secondaryOutcomes': [{'measure': 'Change in glycemic outcomes by CGM-derived metrics', 'timeFrame': 'From baseline to study end after one year', 'description': 'Time in range (glucose levels 3.9-10 mmol/l), time above range (\\>10 mmol/l), time below range (\\<3.9 mmol/l), in percentages of time, measured over the last 14 days.'}, {'measure': 'Change in glycemic outcomes measured by HbA1c', 'timeFrame': 'From baseline to study end after one year', 'description': 'Hba1c in mmol/mol'}, {'measure': 'Change in total daily dose of insulin per kg', 'timeFrame': 'From baseline to study end after one year', 'description': 'Measured as a mean value during the last 14 days'}, {'measure': 'Change in the number of boluses registered per day', 'timeFrame': 'From baseline to study end after one year', 'description': 'registered by the insulin pump, measured as a mean value during the last 14 days'}, {'measure': 'Change in timing of boluses', 'timeFrame': 'From baseline to study end after one year', 'description': 'Missed or late boluses registered by the insulin pump. Measured as a mean value during the last 14 days'}, {'measure': 'Change in carbohydrates/kg entered per day', 'timeFrame': 'From baseline to study end after one year', 'description': 'Registered by the insulin pump. Measured as a mean value during the last 14 days'}, {'measure': 'Change in infusion set wear-time', 'timeFrame': 'From baseline to study end after one year', 'description': 'Registered by the insulin pump. Measured as a mean value during the last 14 days'}, {'measure': 'Change in time in automated insulin delivery mode (AID) on the insulin pump system.', 'timeFrame': 'From baseline to study end after one year', 'description': 'Registered by the insulin pump, in percentages of time during the last 14 days.'}, {'measure': 'Change in conflicts and problems with procedures', 'timeFrame': 'From baseline to study end after one year', 'description': 'Change in conflicts around meals; FLACC (pain and fear scores and conflicts around painful procedures related to diabetes management)'}, {'measure': 'Change in parental fear of hypoglycemia', 'timeFrame': 'From baseline to study end after one year', 'description': 'Change in parental fear of hypoglycemia measured by questionnaire'}, {'measure': 'Change in BMI z-scores', 'timeFrame': 'From baseline to study end after one year', 'description': 'Age, sex, weight, and height will be used to report BMI z-scores for children by using WHO definitions for children in the age; 0-5 and 5-10 years.'}, {'measure': 'Participation in planned modules', 'timeFrame': 'From baseline to study end after one year', 'description': 'Participation pr. year pr. family out of the four held modules.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Children', 'Quality of Life', 'peer support', 'Play', 'Calmness', 'Group-based education'], 'conditions': ['Diabetes', 'Quality of Life', 'Children']}, 'descriptionModule': {'briefSummary': 'The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.', 'detailedDescription': "The investigators encourage families to engage in eating, exercising, playing, and storytelling together, leveraging children's natural inclination to learn through play. This approach allows healthcare providers (HCPs) and parents to gain insights into the child's perspective, improving communication.\n\nThe hypotheses are i) improved calmness during diabetes-related tasks with potential painful procedures such as shift of insulin infusions set and sensor will ease diabetes management and reduce parental distress; ii) improved structure and calmness around meals will ease diabetes management, reflected in interaction with insulin pumps; iii) the group and play-based approach will lead to healthier lifestyle changes compared to usual care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion of children and their families\n\nInclusion Criteria:\n\n* Age 3-10 years\n* Followed at Steno Diabetes Center Copenhagen\n\nExclusion Criteria:\n\n* Severe psychiatric disease\n* Language barriers (Children not speaking Danish, Parents not speaking Danish or English)'}, 'identificationModule': {'nctId': 'NCT07377266', 'acronym': 'StenoChild', 'briefTitle': 'The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks', 'orgStudyIdInfo': {'id': 'H-25016032'}, 'secondaryIdInfos': [{'id': 'p-2024-17600', 'type': 'OTHER', 'domain': 'Danish Data Protection Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'StenoChild intervention', 'description': 'See below, Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design.', 'interventionNames': ['Behavioral: Group consultations and peer-to-peer learning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Care', 'description': 'Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design.', 'interventionNames': ['Other: Standard Care (in control arm)']}], 'interventions': [{'name': 'Group consultations and peer-to-peer learning', 'type': 'BEHAVIORAL', 'description': 'The intervention introduces strategies to promote structured meals, calmness, and balanced diabetes self-management using play and storytelling learning strategies.\n\nFamilies participate in interactive modules in small groups (\\~6-8 families), covering topics like "Meal Calmness" and "Calm Mind" four times during a year (every third month). Parents learn practical techniques to reduce conflict and improve dialogue around diabetes management. Children under 7 receive play-based sessions; those 7 and older receive story-based sessions.\n\nClinical data as well as questionnaires will be collected at each session.', 'armGroupLabels': ['StenoChild intervention']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': 'The control group receives standard care, with the intervention offered later in a waitlist design.\n\nClinical data as well as questionnaires will be collected at baseline and again after one year.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Jannet Svensson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post doctoral researcher, PhD, RN', 'investigatorFullName': 'Nanna Lind', 'investigatorAffiliation': 'Steno Diabetes Center Copenhagen'}}}}