Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-26 @ 10:31 AM
Study NCT ID:
NCT06832059
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial. -A Pilot Study
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in glucose lowering drugs', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Medication status, change in doses or discontinuation of medicine'}, {'measure': 'Personality trait assesment', 'timeFrame': 'Baseline', 'description': 'Assesed fromt the BIG FIVE Inventory questionnaire (BFI-44). Comprising of 44 items.'}, {'measure': 'Physical activity', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Physical activity levels measured by X3 accelerometers'}], 'primaryOutcomes': [{'measure': 'Fidelity testing', 'timeFrame': '12 weeks after baseline', 'description': 'Participants will be invited to a workshop to evaluate the intervention and its components. Procedures from fidelity testing will be applied in the evaluation. These specific topics will be evaluated:\n\n* Study design\n\n o Is the design appropriate? E.g., number of visits, CGM use, dietetic feedback?\n* Sampling strategy\n\n o E.g., how many participated, recruitment methods, sample diversity?\n* Treatment receipt\n\n * "What is learned?"\n * Is the intervention relevant to and accepted by the participants?\n* Treatment enactment\n\n * What is actually used and done?\n * Do participants\' "behavioural skills" improve?'}], 'secondaryOutcomes': [{'measure': 'HbA1c (mmol/mol)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Assessed from blood samples'}, {'measure': 'Time in range (TIR)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Time spent in time in range 3.9 mmol/l - 10.0 mmol/l from CGM data'}, {'measure': 'Time above range (TAR)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Time spent in time above range 10.1-13.9 mmol/l from CGM data'}, {'measure': 'Time below range (TBR)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Time spent in time below range \\<3.9 mmol/l from from CGM data'}, {'measure': 'Coefficient of variation (CV)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Percentage coefficient of variation in glucose differences'}, {'measure': 'Estimated HbA1c', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Estimated HbA1c (14-days average of the CGM data)'}, {'measure': 'Body mass index (kg/m^2)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Calculated from body weight (kg) and height (m).'}, {'measure': 'Body weight (kg)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Measured on a digital scale'}, {'measure': 'Waist circumference (cm)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Measured using tape measure.'}, {'measure': 'Hip circumference (cm)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Measured using tape measure'}, {'measure': 'Systolic blood pressure (mmHg)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Measured under resting'}, {'measure': 'Diastolic blood pressure (mmHg)', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Measured under resting'}, {'measure': 'Self-reported diabetes distress', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Assessed from the Problem Areas in Diabetes Scale comprising of twenty emotional-distress questions. Each item can be rated from 0 to 5.'}, {'measure': 'Self-reported treatment satisfaction', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': 'Assessed from the questionnaire Diabetes Treatment Satisfaction Questionnaire (DTSQ).'}, {'measure': 'Dietary intake', 'timeFrame': 'Measured at baseline and after 12 weeks', 'description': "Dietary intake (total energy intake and macronutrient composition based on 3-days' diet records)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Dietary intervention', 'CGM', 'continuous glucose monitoring'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY', 'detailedDescription': 'In recent decades, there has been a significant rise in the development and use of glucose lowering drugs aimed at improving glycemic control in individuals with type 2 diabetes (T2D). Despite medical advancements, more than one-third of the danish population with T2D have a hemoglobin A1c (HbA1c) exceeding the recommended thresholds. One limiting factor in supporting individuals achieve their glycaemic target may be driven by substantial postprandial increases in plasma glucose levels, which is influenced by the quantity and type of carbohydrates in meals, underscoring the critical role of dietary interventions as an integral component of T2D management.\n\nRecent studies have demonstrated that the use of continuous glucose monitors (CGMs), which allow individuals to track their glucose profiles continuously throughout the day, improves glycemic control in T2D patients. However, these studies often exclude dietary interventions, which could potentially yield greater improvements in blood glucose regulation.\n\nNutritional research in recent years has focused on dietary patterns such as low-fat diets, the paleo diet, and vegan diets. Nevertheless, these studies have not sufficiently addressed individualized dietary adjustments to mitigate postprandial glucose excursions, despite their substantial importance for glycemic control.\n\nSeveral clinical studies have revealed significant inter-individual variations in glycemic responses to identical standardized meals, highlighting the necessity of a personalized approach to dietary recommendations, particularly with a focus on carbohydrate intake.\n\nThe primary aim of this pilot study is to assess the feasibility of a 12-week dietary intervention combined with the use of CGM in adults with T2D. The results of the pilot study will provide insights into recruitment, design, and the effectiveness of the intervention for the future long-term (12-month) PRECISE-DIET STUDY'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2D\n\n * Diabetes duration of ≥12 months\n * ≥18 years of age\n * HbA1c ≥58 mmol/mol\n * Attending the SDCC outpatient clinic\n * Provided voluntary signed informed consent.\n\nExclusion Criteria:\n\n* Inability to understand the patient information.\n* Complications which do not permit to lowering HbA1c to \\<58 mmol/mol.\n* Treatment with insulin.\n* Low daily carbohydrate intake (defined as below 25 E% or 100 g/day) prior to study inclusion.\n* Systematic use of corticosteroids.\n* Using or requiring a specialized diet (e.g., kidney diet).\n* Circumstances that affect HbA1c (e.g., liver disease and anaemia).\n* Known or suspected drug or alcohol abuse (judged by the investigator).\n* Pregnancy or breastfeeding or plans of pregnancy within the study period.\n* Participation in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT06832059', 'briefTitle': 'Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial. -A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in Type 2 Diabetes - The PRECISE-DIET Trial. -A Pilot Study', 'orgStudyIdInfo': {'id': 'H-24083559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precise diet intervention', 'description': 'The precise diet intervention for 12 weeks (n=20).', 'interventionNames': ['Other: The precise diet intervention']}], 'interventions': [{'name': 'The precise diet intervention', 'type': 'OTHER', 'description': "The intervention includes training and education in CGM use and reduction in overall carbohydrate intake guided by individualized flexible nutrition recommendations, with adjustments made according to postprandial blood glucose responses. Staff will guide participants in the daily carbohydrate intake with personalized adjustments to accommodate individual needs by the individuals. The primary goal is to minimize the participant's time spent above 10 mmol/l", 'armGroupLabels': ['Precise diet intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Bettina Ewers, PhD', 'role': 'CONTACT', 'email': 'bettina.ewers@regionh.dk', 'phone': '0045 30912997'}], 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Bettina Ewers, PhD', 'role': 'CONTACT', 'email': 'bettina.ewers@regionh.dk', 'phone': '0045 30912997'}], 'overallOfficials': [{'name': 'Bettina Ewers, PhD', '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': 'Head of Nutrition and PhD', 'investigatorFullName': 'Bettina Ewers', 'investigatorAffiliation': 'Steno Diabetes Center Copenhagen'}}}}