Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 4:07 PM
Study NCT ID:
NCT06977633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking will be used.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single-group, non-randomized study designed to evaluate the accuracy of an investigational continuous glucose ketone sensor in participants with type 1 diabetes. Under controlled inpatient conditions, sensor readings will be compared to reference standards for blood glucose and ketone levels. The study does not include therapeutic interventions or real-time clinical decision-making based on sensor output.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose', 'timeFrame': '5 hours', 'description': 'Correlation between glucose concentrations (mmol/L) measured by the CGM-CKM sensor and plasma glucose concentrations measured with YSI 2300 glucose analyzer.'}, {'measure': 'Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones', 'timeFrame': '5 hours', 'description': 'Correlation between ketone concentrations (mmol/L) measured by the experimental CKM-CKM sensor and blood ketone concentrations measured using commercially available tests.'}], 'secondaryOutcomes': [{'measure': 'Plasma Insulin Concentration Measured by Mercodia ELISA Assay', 'timeFrame': '5 hours', 'description': 'Insulin concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.'}, {'measure': 'Plasma Glucagon Concentration Measured by Mercodia ELISA Assay', 'timeFrame': '5 hours', 'description': 'Glucagon concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes (T1D)']}, 'referencesModule': {'references': [{'pmid': '38847967', 'type': 'BACKGROUND', 'citation': 'Ausri IR, Sadeghzadeh S, Biswas S, Zheng H, GhavamiNejad P, Huynh MDT, Keyvani F, Shirzadi E, Rahman FA, Quadrilatero J, GhavamiNejad A, Poudineh M. Multifunctional Dopamine-Based Hydrogel Microneedle Electrode for Continuous Ketone Sensing. Adv Mater. 2024 Aug;36(32):e2402009. doi: 10.1002/adma.202402009. Epub 2024 Jun 16.'}, {'pmid': '36183355', 'type': 'BACKGROUND', 'citation': 'GhavamiNejad P, GhavamiNejad A, Zheng H, Dhingra K, Samarikhalaj M, Poudineh M. A Conductive Hydrogel Microneedle-Based Assay Integrating PEDOT:PSS and Ag-Pt Nanoparticles for Real-Time, Enzyme-Less, and Electrochemical Sensing of Glucose. Adv Healthc Mater. 2023 Jan;12(1):e2202362. doi: 10.1002/adhm.202202362. Epub 2022 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School. The CGM-CKM device will be applied to the upper arm area of patients and baseline ketone and glucose measurement will be performed for one hour prior to suspending or disconnecting the pump. Upon baseline measurement, the pump will be disconnected for 3 hours while the electrochemical signals are collected from the CGM-CKM device. During the 3 hours of pump disconnection, blood samples will be collected every 5 minutes from participants for analyzing their insulin and glucagon using conventional ELISA kits and glucose and ketone using standard meters.', 'detailedDescription': 'This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes for at least 1 year without significant endogenous insulin production\n* Currently using insulin pump\n* Understanding and willingness to follow the protocol and sign informed consent.\n* Willingness to sign a consent for release of medical information at the time of enrollment\n* Ability to speak, read and write in the language of the investigators.\n\nExclusion Criteria:\n\n* History of DKA or severe hypoglycemia within the past 6 months\n* eGFR \\<45 mL/min/1.73 m2 or other significant renal impairment\n* Pregnancy or breastfeeding\n* Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors\n* Active skin infections or conditions affecting sensor application sites\n* Known skin allergies to tapes or adhesives\n* Current use of any long-acting insulin analogs\n* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol'}, 'identificationModule': {'nctId': 'NCT06977633', 'briefTitle': 'Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM', 'orgStudyIdInfo': {'id': '76354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'People with type 1 diabetes on insulin pump', 'interventionNames': ['Behavioral: Temporary Insulin Suspension', 'Device: Glucose and ketone sensor']}], 'interventions': [{'name': 'Temporary Insulin Suspension', 'type': 'BEHAVIORAL', 'description': 'Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.', 'armGroupLabels': ['People with type 1 diabetes on insulin pump']}, {'name': 'Glucose and ketone sensor', 'type': 'DEVICE', 'description': 'The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.', 'armGroupLabels': ['People with type 1 diabetes on insulin pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Rayhan Lal, MD', 'role': 'CONTACT', 'email': 'inforay@stanford.edu', 'phone': '925-727-1317'}, {'name': 'Ryan Kingman, BS', 'role': 'CONTACT', 'email': 'rkingman@stanford.edu', 'phone': '408-612-1720'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Rayhan Lal, MD', 'role': 'CONTACT', 'email': 'inforay@stanford.edu', 'phone': '650-498-7351'}, {'name': 'Ryan Kingman', 'role': 'CONTACT', 'email': 'rkingman@stanford.edu', 'phone': '650-736-4417'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Sensor measurements and blood plasma levels will be shared via journal/conference publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahla Poudineh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mahla Poudineh', 'investigatorAffiliation': 'University of Waterloo'}}}}