Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:07 AM
Study NCT ID:
NCT07455435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitoring in Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The eligible participants will be randomly allocated to a control group and an experimental group. Both groups will wear CGM for 20 days, with only the experimental group will receive real-time glucose data during the study period. The CGM in the control group will be in the blind mode.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity level', 'timeFrame': 'from day 1 to day 20', 'description': 'step count'}], 'secondaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': 'At day 1 and day 20', 'description': 'flow mediated dilation'}, {'measure': 'arterial stiffness', 'timeFrame': 'at day 1 and day 20', 'description': 'pulse wave velocity'}, {'measure': 'blood glucose', 'timeFrame': 'from day 1 to day 20', 'description': 'average blood glucose from the CGM sensor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prediabetes']}, 'descriptionModule': {'briefSummary': "This research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects more than 1 in 10 Americans and costs the nation $327 billion annually. Even though it's clear that physical activity helps prevent diabetes, and that even small increases in daily movement (like walking or climbing stairs) can significantly lower risk, getting people to be more active remains challenging.\n\nA device called a continuous glucose monitor (CGM) might offer a solution. This small wearable sensor tracks blood sugar levels throughout the day and sends the information to a phone or watch. While these devices are already helping people who have diabetes manage their condition better, the investigators want to study if wearing a CGM may encourage at-risk people to become more physically active. The investigators are particularly interested in seeing whether real-time blood sugar data plus education can be an effective tool to promote lifestyle changes, such as walk more steps every day.\n\nThe study also aims to examine whether using a CGM helps stabilize blood sugar levels in prediabetes. The researchers believe that even short-term use of these monitors could lead to increased physical activity and more stable blood sugar levels, potentially helping prevent diabetes development.", 'detailedDescription': "The current research landscape shows Type 2 diabetes (T2D) as a major public health challenge, affecting more than 10% of Americans with staggering annual costs of $327 billion. Research has clearly established the protective role of physical activity in T2D prevention, with studies showing that even modest increases in daily activity (14 minutes) can reduce T2D risk by 9%, while sedentary behavior like television viewing can significantly increase risk by 30%. These findings underscore the critical importance of physical activity in diabetes prevention strategies.\n\nContinuous Glucose Monitoring (CGM) technology has emerged as a valuable tool in diabetes management, with the American Diabetes Association now recommending its use for diabetes self-management. While CGM's effectiveness in improving blood sugar control among diagnosed T2D patients is well-documented, there's a notable gap in research regarding its potential as a preventive tool. Specifically, no studies have examined whether real-time glucose feedback from CGM devices might encourage increased physical activity among people at risk for developing T2D.\n\nIndividuals at risk for type 2 diabetes, such as with prediabetes, were chosen as the study population for several strategic reasons. First, this aligns with a prevention-focused approach, as research shows that lifestyle interventions can effectively delay or prevent diabetes onset in high-risk populations. Second, there's a significant knowledge gap regarding CGM use in prevention - while its benefits for diagnosed diabetes patients are well-documented, its potential as a preventive tool remains unexplored. The study specifically targets individuals with pre-diabetes diagnosis and BMI \\> 25, while excluding those with prior CGM experience or who use glucose-affecting medications to ensure valid results. This population choice also addresses health equity concerns, as type 2 diabetes disproportionately affects underserved communities, making prevention strategies particularly valuable for these groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 years or older Prediabetes confirmed by the recent lab tests (within three month). If not available, it will be confirmed at lab Body mass index (BMI) \\>= 25 kg/m2 Ability to provide informed consent Ownership of a smartphone compatible with Dexcom G6 application Willing and able to comply with study procedures for 20 days\n\nExclusion Criteria:\n\nDiabetes and Glycemic Management:\n\n* Diagnosed type 1 or type 2 diabetes mellitus\n* Current use of glucose-lowering medications (metformin, sulfonylureas, GLP-1 agonists, SGLT2 inhibitors, insulin, etc.)\n* HbA1c \\>= 6.5% or fasting plasma glucose \\>= 126 mg/dL\n\nCardiovascular Conditions:\n\n* History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)\n* Peripheral artery disease\n* Uncontrolled hypertension (systolic BP \\> 160 mmHg or diastolic BP \\> 100 mmHg)\n* Raynaud phenomenon or other conditions affecting peripheral vascular assessment\n* Atrial fibrillation or other arrhythmias affecting pulse wave velocity measurement\n\nMedications Affecting Vascular Function:\n\n* Current use of vasoactive medications (nitrates, phosphodiesterase inhibitors)\n* Recent changes (\\< 4 weeks) in antihypertensive medications\n* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)\n* Systemic corticosteroid use\n\nPhysical Activity Limitations:\n\n* Physical disability or musculoskeletal condition preventing normal ambulation\n* Use of mobility aids (wheelchair, walker, cane)\n* Medical advice to limit physical activity\n\nOther Exclusions:\n\n* Pregnancy or lactation\n* Active cancer or cancer treatment within the past 5 years (excluding non-melanoma skin cancer)\n* Chronic kidney disease (eGFR \\< 60 mL/min/1.73m2)\n* Liver disease (ALT or AST \\> 3x upper limit of normal)\n* Thyroid disease (unless stable on treatment for \\> 3 months)\n* Current participation in a weight loss program or clinical trial\n* Skin conditions preventing CGM sensor placement\n* Known allergy to CGM adhesive\n* Shift work or irregular sleep schedule (may affect CGM patterns)\n* Planned travel during study period that would interfere with study visits'}, 'identificationModule': {'nctId': 'NCT07455435', 'briefTitle': 'Continuous Glucose Monitoring in Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Hartford'}, 'officialTitle': 'Continuous Glucose Monitoring as a Tool to Promote Physical Activity in Prediabetes', 'orgStudyIdInfo': {'id': '25-01-397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CGM Blind group', 'description': 'The control group will wear the CGM for 20 days but without access to the real-time glucose data (blind mode). They will receive the data upon completion of the study.'}, {'type': 'EXPERIMENTAL', 'label': 'CGM Unblind group', 'description': 'The CGM unblind group will wear the CGM for 20 days. They will have the real time glucose data during the study.', 'interventionNames': ['Behavioral: CGM Access']}], 'interventions': [{'name': 'CGM Access', 'type': 'BEHAVIORAL', 'description': 'The intervention is the access to the real-time glucose via a CGM system.', 'armGroupLabels': ['CGM Unblind group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jinghui Yang, PT, MPT, PhD', 'role': 'CONTACT', 'email': 'jiyang@hartford.edu', 'phone': '347-429-0843'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Expected from May 2027 to Dec 2027', 'ipdSharing': 'YES', 'description': 'I will share the coded data with the reviewer or editor if needed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hartford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jinghui Yang', 'investigatorAffiliation': 'University of Hartford'}}}}