230
Participants
Start Date
July 13, 2018
Primary Completion Date
March 31, 2021
Study Completion Date
March 31, 2022
Usual Care
Usual Care participants will receive the same excellent multidisciplinary Care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is \< 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.
Transdisciplinary Care-In Person & Telehealth
TC participants will receive all elements of the Usual Care intervention but they will do so in the context of face to face or telehealth delivery of TC follow-up visits with simultaneous involvement of an advanced practice nurse, dietitian and psychologist at each visit.
Alfred I. duPont Hospital for Children, Wilmington
Nemours Children's Clinic, Jacksonville
Nemours Children's Hospital, Orlando
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Nemours Children's Clinic
OTHER