Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-05 @ 12:48 AM
Study NCT ID:
NCT06465693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HgbA1c', 'timeFrame': 'week 12'}], 'secondaryOutcomes': [{'measure': 'Glucose variability/coefficient of variation', 'timeFrame': 'week 12', 'description': 'using CGM data'}, {'measure': 'mean glucose', 'timeFrame': 'week 12', 'description': 'using CGM data'}, {'measure': 'time in range (glucose 70-180 mg/dl)', 'timeFrame': 'week 12', 'description': 'using CGM data'}, {'measure': 'time above range (glucose 70-180 mg/dl)', 'timeFrame': 'week 12', 'description': 'using CGM data'}, {'measure': 'Weight', 'timeFrame': 'week 12'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'week 12'}, {'measure': 'Fasting serum insulin', 'timeFrame': 'week 12'}, {'measure': 'Serum lipid panel', 'timeFrame': 'week 12'}, {'measure': 'Intervention Acceptability Questionnaire', 'timeFrame': 'week 12'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire (DTSQ)', 'timeFrame': 'week 12'}, {'measure': 'Diet Satisfaction Questionnaire (DSat-28)', 'timeFrame': 'week 12'}, {'measure': 'Diabetes Management Self-Efficacy Scale (DMSES)', 'timeFrame': 'week 12'}, {'measure': 'Medication Effect Score', 'timeFrame': 'week 12'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Have a previous diagnosis of type 2 diabetes\n* HbA1c of 7.0 - 9.5%\n* Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Treatment with insulin, sulfonylurea, or meglitinide\n* Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)\n* BMI \\<25 kg/m2\n* Weight change \\>5 pounds in the 3 months prior to enrollment\n* Estimated glomerular filtration rate \\<60 ml/minute/1.73 m2\n* Pregnant or breastfeeding\n* Anemia (which affects HbA1c)\n* Presence of any disease that would make adherence to the protocol difficult'}, 'identificationModule': {'nctId': 'NCT06465693', 'briefTitle': 'Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'MED-2023-32168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1', 'description': 'After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy', 'interventionNames': ['Device: Unblinded CGM plus nutrition therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only', 'interventionNames': ['Behavioral: Nutrition therapy only']}], 'interventions': [{'name': 'Unblinded CGM plus nutrition therapy', 'type': 'DEVICE', 'description': 'will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.\n\nwill receive Dexcom G6 Pro CGMs to wear throughout the study. The CGM will be unblinded so that the glucose data will be available in real time to the participant and investigators. The dietitian and participant will review CGM data together', 'armGroupLabels': ['Group1']}, {'name': 'Nutrition therapy only', 'type': 'BEHAVIORAL', 'description': 'will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Anne Bantle, MD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}