Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 3:43 AM
Study NCT ID:
NCT06862128
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OGTT at Home Using CGM vs at the Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'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': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-03-01', 'studyFirstSubmitQcDate': '2025-03-01', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation coefficient between the glucose levels of the OGTT-home vs OGTT-clinic', 'timeFrame': 'Between OGTT-clinic at baseline vs OGTT-home at each 5-min interval from 0-30 min; Between OGTT-clinic at 1 h vs OGTT-home at each 5-min interval from 60-90 min; Between OGTT-clinic at 2 h vs OGTT-home at each 5-min interval from 120-150 min', 'description': 'The correlation coefficient between the glucose levels of the OGTT at home vs at the clinic'}, {'measure': 'The sensitivity and specificity, as well as the positive and negative predictive values of the OGTT at home vs the OGTT at the clinic', 'timeFrame': 'At 1 and 2 hours after the start of the OGTT', 'description': 'The sensitivity and specificity, as well as the positive and negative predictive values of pre-diabetes and diabetes of the OGTT-CGM with the highest correlation coefficient to the OGTT-CLI, at 1 and 2 hours after the start of the OGTT'}], 'secondaryOutcomes': [{'measure': 'The sensitivity, specificity, positive and negative predictive value of the highest OGTT-home vs OGTT-clinic', 'timeFrame': 'Any of the values from 5-minute intervals 0-150 minutes of OGTT-home vs OGTT-clinic at 1 and 2 hours, respectively', 'description': 'The sensitivity, specificity, positive and negative predictive value of the highest glucose value form the OGTT at home vs the value of OGTT at the clinic at 1 and 2 hours, respectively'}, {'measure': 'The sensitivity, specificity, positive and negative predictive value of the highest CGM value vs OGTT-clinic', 'timeFrame': 'Any of the values from 5-minute intervals days 1-14 of the CGM vs OGTT-clinic at 1 and 2 hours, respectively', 'description': 'The sensitivity, specificity, positive and negative predictive value of the highest glucose value form the CGM vs the value of OGTT at the clinic at 1 and 2 hours, respectively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-diabetes', 'Diabetes', 'Oral glucose tolerance test', 'Continuous glucose monitoring', 'Glucose'], 'conditions': ['Pre-diabetes', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Participants with prediabetes will undergo both home-based and clinic-based OGTTs, with glucose levels measured via CGM and venous plasma glucose. The primary outcome is the correlation between CGM-based glucose values and standard OGTT results. Secondary outcomes include diagnostic agreement, metabolic hormone associations, and feasibility of home-based testing as a diagnostic tool for dysglycemia.', 'detailedDescription': 'This study aims to evaluate the feasibility, accuracy, and diagnostic utility of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT.\n\nStudy Design Type: Randomized, crossover study Participants: 75 adults with prediabetes Intervention: Each participant will complete both a home-based OGTT with CGM and a clinic-based OGTT with venous plasma glucose measurement.\n\nPrimary Objective To assess the correlation between glucose values obtained from a CGM-based home OGTT and a standard venous OGTT performed in the clinic.\n\nSecondary Objectives Evaluate diagnostic agreement between CGM-derived and venous glucose measurements.\n\nAssess variability in glucose responses between the two methods. Investigate associations between OGTT results and metabolic/sex hormones. Determine feasibility and patient adherence to home-based testing.\n\nMethods Participants will be randomized into two groups: one starting with a clinic-based OGTT, the other with a home-based OGTT, followed by a crossover period. CGM will continuously monitor glucose responses, and standard venous plasma glucose measurements will serve as the reference method.\n\nClinical Relevance A validated home-based OGTT using CGM could improve access to glucose tolerance testing, reduce patient burden, and enhance early detection of dysglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prediabetes indicated by ≥2 of the following values, measured at separate occasions or through different analyses during the past 2 years:\n* \\- Fasting venous plasma glucose ≥6.1 but ≤6.9 mmol/L\n* \\- Non-fasting venous plasma glucose ≥7.8 but ≤11.0 mmol/L\n* \\- HbA1c ≥39 but ≤47 mmol/mol\n* Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity\n* Ability to read and respond to online instructions and questionnaires in Swedish.\n\nExclusion Criteria:\n\n* T2D indicated by ≥2 of the following values, measured at different occasions or through different analyses:\n* \\- Fasting venous plasma glucose ≥7.0 mmol/L\n* \\- Non-fasting venous plasma glucose value ≥11.1 mmol/L\n* \\- HbA1c ≥48 mmol/mol\n* Previous bariatric surgery e.g., gastric by-pass or gastric sleeve surgery\n* Body mass index \\<20 kg/m2\n* Body weight \\<43 kg\n* Current pregnancy\n* Need of regular use of GLP-1 receptor agonists, SGLT-2 inhibitors, acetaminophen or ascorbic acid supplements during the study period\n* Fear of needle sticks\n* Shift work during the study period\n* Involvement in the study design, data collection, analysis, or participant recruitment.'}, 'identificationModule': {'nctId': 'NCT06862128', 'acronym': 'OGTT-CGM', 'briefTitle': 'OGTT at Home Using CGM vs at the Clinic', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Oral Glucose Tolerance Test at Home With Continuous Glucose Monitoring vs Standard Clinic-based Testing', 'orgStudyIdInfo': {'id': 'ogtt_cgm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OGTT at the clinic then at home', 'description': 'OGTT at the clinic then at home', 'interventionNames': ['Diagnostic Test: OGTT at home using CGM', 'Diagnostic Test: OGTT at the clinic']}, {'type': 'EXPERIMENTAL', 'label': 'OGTT at home then at the clinic', 'description': 'OGTT at home then at the clinic', 'interventionNames': ['Diagnostic Test: OGTT at home using CGM', 'Diagnostic Test: OGTT at the clinic']}], 'interventions': [{'name': 'OGTT at home using CGM', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['OGTT-home'], 'description': 'OGTT at home using CGM', 'armGroupLabels': ['OGTT at home then at the clinic', 'OGTT at the clinic then at home']}, {'name': 'OGTT at the clinic', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['OGTT-clinic'], 'description': 'OGTT at the clinic', 'armGroupLabels': ['OGTT at home then at the clinic', 'OGTT at the clinic then at home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55185', 'city': 'Huskvarna', 'state': 'Jönköping County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Samefors, MD, PhD', 'role': 'CONTACT', 'email': 'maria.samefors@liu.se', 'phone': '+46102423550'}], 'facility': 'Primary Health Care Center Bra Liv Rosenhälsan', 'geoPoint': {'lat': 57.78596, 'lon': 14.30214}}, {'zip': '60239', 'city': 'Norrköping', 'state': 'Norrköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Peder af Geijerstam, MD, PhD', 'role': 'CONTACT', 'email': 'peder.af.geijerstam@liu.se', 'phone': '+46101059140'}], 'facility': 'Primary Health Care Center Cityhälsan Centrum', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': '58662', 'city': 'Linköping', 'state': 'Östergötland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Karin Rådholm, MD, PhD', 'role': 'CONTACT', 'email': 'karin.radholm@liu.se', 'phone': '+4613281756'}], 'facility': 'Primary Care Center Vårdcentralen Kärna', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'centralContacts': [{'name': 'Peder af Geijerstam, MD, PhD', 'role': 'CONTACT', 'email': 'peder.af.geijerstam@liu.se', 'phone': '+46739597426'}], 'overallOfficials': [{'name': 'Peder af Geijerstam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If suitable according to ethical guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Region Jönköping County', 'class': 'OTHER_GOV'}, {'name': 'Region Östergötland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peder af Geijerstam', 'investigatorAffiliation': 'Linkoeping University'}}}}