[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07459582":3,"trial-entities:NCT07459582":82,"trial-summary:NCT07459582":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":25,"primary_purpose":16,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":42,"sex":45,"minimum_age":16,"maximum_age":46,"healthy_volunteers":14,"eligibility_criteria":47,"std_ages":51,"locations":54,"central_contacts":70,"overall_officials":75,"references":80,"see_also_links":81},"NCT07459582","25-061","Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease","RECRUITING","2027-12","2026-05","2026-06-01","2026-08","Connecticut Children's Medical Center","OTHER",false,"The goal of this study is to determine if the Lactate Plus meter is accurate compared to lab lactate levels, and to determine if the Accu chek guide glucometer is accurate compared to lab serum glucose levels in patients with Glycogen Storage Disease Types Ia, Ib and XI.\n\nTo determine this, patient's will have a one-time planned admission to Connecticut Children's for approximately 8 hours and receive hourly blood draws as well as finger-sticks.",null,[18,19,20,21],"Glycogen Storage Disease Type IA","Glycogen Storage Disease Type I","Glycogen Storage Disease Type IB","Glycogen Storage Disease Xi",[23,24],"lactate","blood glucose","OBSERVATIONAL",[],{"count":28,"type":29},10,"ESTIMATED",[31,34],{"type":13,"name":32,"description":33},"Lactate Meter","Hourly blood lactate levels",{"type":35,"name":36,"description":37},"DEVICE","Accu Chek","Hourly blood glucose levels",[39],{"measure":40,"timeFrame":41},"To determine if the lactate Plus meter (both capillary and serum sample) readings are within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type Ia\u002FIb\u002FXI","Hourly x 8 hours",[43],{"measure":44,"timeFrame":41},"To determine if the Accu-Chek Guide glucometer (capillary sample) readings are within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type Ia\u002FIb\u002FXI","ALL","60 Years",{"inclusion":48,"exclusion":49,"raw_text":50},[],[],"Inclusion Criteria:\n\n1. Patients with diagnosed\u002Fconfirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia\u002FIb (ICD 10 code: E74.01) or XI (74.09).\n2. For pediatric participants: Ability of child's parent\u002Flegal guardian to understand and the willingness to sign a written informed consent document\n3. For adolescents: assent to participate\n4. For adults: Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n1. Patients with Glycogen storage disease unspecified\n2. Patients not meeting inclusion criteria\n3. Patients unable to provide consent\n4. Patients who decline to be in the study",[52,53],"CHILD","ADULT",[55],{"facility":56,"status":7,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":67},"Connecticut Children's","Hartford","Connecticut","06106","United States",[62],{"name":63,"role":64,"phone":65,"email":66},"Malaya Mount, MS, RD, CDN","CONTACT","860-837-6700","mmount@connecticutchildrens.org",{"lat":68,"lon":69},41.76371,-72.68509,[71,72],{"name":63,"role":64,"phone":65,"email":66},{"name":73,"role":64,"phone":74},"Malaya Mount","3608889293",[76,78],{"name":63,"affiliation":56,"role":77},"PRINCIPAL_INVESTIGATOR",{"name":79,"affiliation":56,"role":77},"Rebecca Riba-Wolman, MD",[],[],{"nct_id":4,"conditions":83,"biomarkers":87},[84,85,86],"Glycogen Storage Disease Type Ia","Glycogen Storage Disease Type Ib","Glycogen Storage Disease Type XI",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":99},true,{"design":91,"status":92,"heading":6,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an observational study involving 10 participants. It is designed to compare readings from home devices with lab results.","completed","This study is looking at how accurate two home devices are for people with certain types of Glycogen Storage Disease (GSD) – specifically Types Ia, Ib, and XI. We want to see if the Lactate Plus meter, which measures lactate levels, and the Accu-chek glucometer, which measures blood sugar, give readings that are close to what a lab test would show. To do this, you would come to Connecticut Children's for about 8 hours. During this time, we would take hourly blood samples and also do finger-pricks to compare the readings from the home devices with lab results. We are looking for the home lactate meter readings to be within 20% of the lab results 95% of the time. This study is for people of all genders, from infants to 60 years old, who have a confirmed diagnosis of GSD Type Ia, Ib, or XI.","Not specified.",145,"You would have a one-time, 8-hour visit to Connecticut Children's, where you would have hourly blood draws and finger-sticks.","Not stated in the trial record.",[32],"v2"]