[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07696273":3,"trial-entities:NCT07696273":126,"trial-summary:NCT07696273":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":70,"locations":73,"central_contacts":92,"overall_officials":101,"references":105,"see_also_links":125},"NCT07696273","31571","Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia","Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes","RECRUITING","2027-10-01","2026-07","2026-07-10","2026-05-31","Indiana University","OTHER",false,"The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds (VOCs) in exhaled breath.","At this stage, the team will deploy two different analytical platforms in parallel in a clinical study to survey exhaled breath volatile organic compound (VOC) profiles at a diabetes youth camp. The ultimate objective is to determine whether a miniaturized laboratory device incorporating metal oxide gas sensors can reliably distinguish specific VOCs associated with glycemic events under real-world conditions. Sensor responses will be validated through parallel breath collection using Tedlar (plastic) bags, followed by confirmatory analysis via gas chromatography-mass spectrometry (GC-MS).",[19,20,21],"Diabetes","Hyperglycemia","Hypoglycemia (Diabetic)",[23,24,25,26,27],"Exhaled Breath Analysis","Volatile Organic Compounds (VOCs)","Metal Oxide Sensors","Gas Chromatography","Mass Spectrometry","INTERVENTIONAL","DIAGNOSTIC",[31],"NA",{"count":33,"type":34},40,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","Sensing Device and Tedlar Bags","Children diagnosed with diabetes that wear a continuous glucose monitor (CGM) will provide breath samples into the miniaturized sensing device (as well as Tedlar bags for GC-MS analysis) during euglycemia, hypoglycemia, and hyperglycemia. The breath data will be analyzed to draw correlations with blood glucose levels measured via CGMs and finger prick tests.",[41],"Diabetic Children Attending a Summer Youth Camp with Continuous Glucose Monitors",[43],{"measure":44,"description":45,"timeFrame":46},"Sensor Features Correlate with Blood Glucose Measurements","Detection of exhaled VOC concentrations via the miniaturized laboratory device that correlate with hyper- and hypoglycemic episodes determined through finger stick and CGM data. It is anticipated that the device will be capable of noninvasively estimating blood glucose levels with approximately 30% agreement relative to CGM measurements, while accurately identifying hypo- and hyperglycemic events with greater than 85-90% sensitivity\u002Fspecificity.","1 week for the summer camp.",[48],{"measure":49,"description":50,"timeFrame":46},"GC-MS Analysis of VOCs Correlate with Blood Glucose and Sensor Data","Specific VOCs identified through GC-MS analysis are expected to correlate not only with blood glucose levels and hypo-\u002Fhyperglycemic events, but also with extracted features of the sensor response. It is anticipated that select VOCs will exhibit statistically significant correlations (R \\> 0.70) with glycemic measures and may demonstrate stronger associations with blood glucose levels and glycemic state classification compared to the metal oxide gas sensor array.","ALL","7 Years","25 Years",{"inclusion":55,"exclusion":63,"raw_text":69},[56,57,58,59,60,61,62],"Who are diagnosed with T1D or T2D.","Who are between 7-25 years of age.","That use a Dexcom (G6 or G7) CGM device.","That have an established working CGM for at least 12 hours.","That are willing to share their CGM data for the study duration.","That are willing and able to fill up a breath collection bag.","That are attending a diabetes camp in the state of Indiana.",[64,65,66,67,68],"That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp).","That have a condition or abnormality other than T1D\u002FT2D that in the opinion of the Investigators would compromise the safety of the subject or the quality of the data.","That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral\u002Fbacterial infections).","That follow a \"ketogenic diet\".","That are unable or unwilling to cooperate with either of the sample collection modes.","Inclusion Criteria:\n\n* Who are diagnosed with T1D or T2D.\n* Who are between 7-25 years of age.\n* That use a Dexcom (G6 or G7) CGM device.\n* That have an established working CGM for at least 12 hours.\n* That are willing to share their CGM data for the study duration.\n* That are willing and able to fill up a breath collection bag.\n* That are attending a diabetes camp in the state of Indiana.\n\nExclusion Criteria:\n\n* That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp).\n* That have a condition or abnormality other than T1D\u002FT2D that in the opinion of the Investigators would compromise the safety of the subject or the quality of the data.\n* That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral\u002Fbacterial infections).\n* That follow a \"ketogenic diet\".\n* That are unable or unwilling to cooperate with either of the sample collection modes.",[71,72],"CHILD","ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"Jameson Camp","Indianapolis","Indiana","46231","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Joe Esten","CONTACT","608-390-6398","JEsten@diabetes.org",{"name":87,"role":88},"Linda DiMeglio, MD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},39.76838,-86.15804,[93,97],{"name":94,"role":83,"phone":95,"email":96},"Mangilal Agarwal, PhD","317-278-9792","agarwal@iu.edu",{"name":98,"role":83,"phone":99,"email":100},"Akanksha Tipparti, M.S.","317-626-9725","atippart@iu.edu",[102,103],{"name":87,"affiliation":13,"role":88},{"name":104,"affiliation":13,"role":88},"Mark Woollam, PhD",[106,110,113,116,119,122],{"pmid":107,"type":108,"citation":109},"40762732","BACKGROUND","Woollam M, Christensen A, Schulz E, Eckerle S, Davis MD, Sanders DB, Agarwal M. Systematic comparison of methods for offline breath sampling. Anal Bioanal Chem. 2025 Sep;417(22):5061-5076. doi: 10.1007\u002Fs00216-025-06025-5. Epub 2025 Aug 5.",{"pmid":111,"type":108,"citation":112},"39160864","Heranjal S, Maciel M, Kamalapally SNR, Ramrakhiani I, Schulz E, Cao S, Liu X, Relich RF, Wek R, Woollam M, Agarwal M. Establishing Healthy Breath Baselines With Tin Oxide Sensors: Fundamental Building Blocks for Noninvasive Health Monitoring. Mil Med. 2024 Aug 19;189(Suppl 3):221-229. doi: 10.1093\u002Fmilmed\u002Fusae078.",{"pmid":114,"type":108,"citation":115},"40414890","Woollam M, Angarita-Rivera P, Thakur S, Daneshkhah A, Siegel AP, Hardin DS, Agarwal M. Steps toward clinical validation of exhaled volatile organic compound biomarkers for hypoglycemia in persons with type 1 diabetes. Sci Rep. 2025 May 25;15(1):18257. doi: 10.1038\u002Fs41598-025-00284-z.",{"pmid":117,"type":108,"citation":118},"28294961","Daneshkhah A, Shrestha S, Siegel A, Varahramyan K, Agarwal M. Cross-Selectivity Enhancement of Poly(vinylidene fluoride-hexafluoropropylene)-Based Sensor Arrays for Detecting Acetone and Ethanol. Sensors (Basel). 2017 Mar 15;17(3):595. doi: 10.3390\u002Fs17030595.",{"pmid":120,"type":108,"citation":121},"35453137","Woollam M, Angarita-Rivera P, Siegel AP, Kalra V, Kapoor R, Agarwal M. Exhaled VOCs can discriminate subjects with COVID-19 from healthy controls. J Breath Res. 2022 May 6;16(3). doi: 10.1088\u002F1752-7163\u002Fac696a.",{"pmid":123,"type":108,"citation":124},"28569238","Siegel AP, Daneshkhah A, Hardin DS, Shrestha S, Varahramyan K, Agarwal M. Analyzing breath samples of hypoglycemic events in type 1 diabetes patients: towards developing an alternative to diabetes alert dogs. J Breath Res. 2017 Jun 1;11(2):026007. doi: 10.1088\u002F1752-7163\u002Faa6ac6.",[],{"nct_id":4,"conditions":127,"biomarkers":130},[128,129],"Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":132,"summary":133,"prompt_version":143},true,{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This interventional study plans to enroll 40 participants. It is testing a Sensing Device and Tedlar Bags.","completed","Miniaturized Breath Sensor for Diabetes Management","This study is testing a new, small device called a Sensing Device that can detect changes in blood sugar (glucose) levels by analyzing your breath. We want to see if this device can tell when someone with diabetes has high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia) by looking for specific chemicals in their breath. You can join if you are 7 to 25 years old, have type 1 or type 2 diabetes, use a Dexcom G6 or G7 continuous glucose monitor (CGM), and are attending a diabetes camp in Indiana. The main goal is to see if the signals from this breath sensor match your blood glucose readings from your CGM over one week during the summer camp.","Your sensor features will be correlated with blood glucose measurements for 1 week during the summer camp.",120,"You would provide breath samples into the miniaturized sensing device and Tedlar bags during normal, low, and high blood sugar levels. You also need to share your CGM data for the study duration and be able to fill a breath collection bag.","Not stated in the trial record.",[],"v2"]