| Outcome Measures: |
Primary: Change from baseline in 2-hour AUC of C-peptide response to the Mixed Model Tolerance Test (MMTT), C-peptide level is an indirect measure of pancreatic beta-cell function. The MMTT was performed after an overnight fast, at baseline, Month 6 | Secondary: Change from baseline in 2-hour AUC of C-peptide response to the MMTT, Months 12, 18 and 24|Change in HbA1c from baseline, Months 6, 12, 18 and 24|Time in range (TIR) by Continuous Glucose Monitoring (CGM), Months 6, 12, 18, 24|Proportion of patients with HbA1c <7% who did not experience severe hypoglycemic events during treatment, Months 6, 12, 18, 24|Average (previous 3 days) daily insulin requirement (IU/kg/day), Months 6, 12, 18, 24|Proportion of patients with HbA1c <7% and daily insulin requirement <0.5 (IU/kg/day), Months 6, 12, 18, 24|Additional Glucose Variability Indices derived from CGM, Additional Glucose Variability Indices derived from CGM (glucose AUC outside the target range of 70 - 180 mg/dL, 2-hour postprandial glucose (PPG))., Months 6, 12, 18 and 24|Additional Glucose Variability Indices derived from MAGE, Additional Glucose Variability Indices derived from Mean Amplitude Glycemic Excursions (MAGE), Months 6, 12, 18 and 24|Additional Glucose Variability Indices derived from CONGA-n, Additional Glucose Variability Indices derived from continuous overall net glycemic action (CONGA)-n, Months 6, 12, 18 and 24|Additional Glucose Variability Indices derived from MODD, Additional Glucose Variability Indices derived from Mean Of the Daily Differences (MODD)., Months 6, 12, 18 and 24|Additional Glucose Variability Indices derived from mean daily blood glucose, SD, Additional Glucose Variability Indices derived from mean daily blood glucose, SD (Standard Deviation)., Months 6, 12, 18 and 24|Number of self-reported episodes of severe hypoglycemia, For the purpose of this study, a severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level \<54mg/dL or prompt recovery after oral carbohydrate, i.e. glucose, or glucagon administration., Months 6, 12, 18, 24|Percentage of patients not requiring insulin therapy, This outcome aims to assess the % of patients who do not require an insulin therapy, Months 6, 12, 18, 24|Estimated Glucose Disposal Rate (eGDR), Estimated Glucose Disposal Rate (eGDR) is a marker for the Assessment of Insulin Resistance and a validated clinical tool for estimating insulin sensitivity in type 1 diabetes., Months 6, 12, 18, 24
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| Locations: |
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC), Birmingham, Alabama, 35294, United States|Phoenician Centers for Research and Innovation, Phoenix, Arizona, 85021, United States|University of California San Diego, La Jolla, California, 92093, United States|Center of Excellence in Diabetes & Endocrinology (CEDE), Sacramento, California, 95821-2123, United States|University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic, Aurora, Colorado, 80045, United States|Christiana Care Endocrinology Specialists, Newark, Delaware, 19713, United States|Diabetes Care Center - Hudson, Hudson, Florida, 34667-7151, United States|Global Life Research Network, Miami, Florida, 33155, United States|AdventHealth (Florida Hospital) - Diabetes Institute - Orlando, Orlando, Florida, 32804, United States|Atlanta Diabetes Associates (ADA), Atlanta, Georgia, 30318, United States|The University of Chicago, Chicago, Illinois, 60637, United States|Prairie Education and Research Cooperative d/b/a Central Illinois Diabetes and Clinical, Springfield, Illinois, 62711, United States|Indiana University - Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|The Cotton-O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606-28, United States|University of Louisville, Louisville, Kentucky, 40292, United States|Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, 02215, United States|UBMD Physicians Group - Pediatrics - Conventus, Buffalo, New York, 14203, United States|"WakeMed Physician Practices - Pediatric Endocrinology - WakeMed Raleigh Medical Park Location", Raleigh, North Carolina, 27610, United States|University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, 19104, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States|UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|University of Pittsburgh - UPMC, Pittsburgh, Pennsylvania, 15261, United States|Cook Children's Endocrinology and Diabetes Program, Fort Worth, Texas, 76104, United States|Texas Children's Hospital, Houston, Texas, 77030, United States|Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center, Norfolk, Virginia, 23510, United States|Clinique du Sud Luxembourg - Vivialia-Arlon, Arlon, Belgium|Universitair Ziekenhuis Brussel (UZB), Jette, Belgium|General Hospital AZ Nikolaas, Sint-Niklaas, Belgium|Aleksandre Aladashvili Clinic LLC, Tbilisi, 48102, Georgia|National Center for Diabetes Research LTD, Tbilisi, 48159, Georgia|National Institute of Endocrinology LTD, Tbilisi, 48159, Georgia|Tbilisi Heart and Vascular Clinic LTD, Tbilisi, 48159, Georgia|Medical Center - University of Freiburg, Freiburg, Germany|Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III, Glessen, 35392, Germany|Diabestesinstitut Heidelberg, Heidelberg, Germany|Die Praxis am Ludwigsplatz, Ludwigshafen am Rhein, Germany|Institut fuer Diabetes forschung in Muenster (IDFM), Münster, Germany|Schwerpunktpraxis fuer Diabetes & Ernaehrungsmedizin, Münster, Germany|Soroka Medical Center, Be'er Sheva, Israel|Schneider Children's Medical Center, Petah Tikva, Petah Tikva, 4920235, Israel|Tel Aviv Sourasky Medical Center, Tel Aviv-Yafo, Israel|Ospedale Pediatrico G. Salesi - Centro Regionale di Diabetologia Clinica Pediatrica, Ancona, 60123, Italy|Azienda Ospedaliero-Universitaria Conzorziale Policlinico di Bari, Bari, 70124, Italy|Università degli Studi Magna Graecia di Catanzaro, Azienda Ospedaliero-Universitaria Mater Domini, Catanzaro, Italy|Universitá degli Studi di Milano - Ospedale Luigi Saco, Milan, 20157, Italy|Centro regionale di Diabetologia Pediatrica "G. Stoppoloni", Azienda Ospedaliera Universitaria "Luigi Vanvitelli", Napoli, Italy|Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy|Università Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario, Roma, 00128, Italy|Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu, Roma, Italy|Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli", Roma, Italy|"Sapienza" Università di Roma- Azienda Ospedaliero Universitaria Policlinico Umberto I, Rome, 00161, Italy|Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases, Belgrade, 11000, Serbia|University Children's Hospital, Belgrade, Serbia|Clinical center Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases, Kragujevac, 34000, Serbia|Clinical Center Nis, Clinic for endocrinology, Niš, 18000, Serbia|Clinical Center Nis, Clinic for endocrinology, Niš, Serbia|University Children's Hospital, University Medical Center Ljubljana, Lubiana, Slovenia
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