Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

NACompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

July 13, 2018

Primary Completion Date

March 31, 2021

Study Completion Date

March 31, 2022

Conditions
Type 1 Diabetes Mellitus
Interventions
OTHER

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.

BEHAVIORAL

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.

Trial Locations (3)

16803

Alfred I. duPont Hospital for Children, Wilmington

32207

Nemours Children's Clinic, Jacksonville

33827

Nemours Children's Hospital, Orlando

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Nemours Children's Clinic

OTHER

NCT03557151 - Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence | Biotech Hunter | Biotech Hunter