drugset / Trial / NCT03463564

Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients

NCT03463564

Phase 4 Recruiting 150 enrolled University of Campania Luigi Vanvitelli
RandomizedParallel-groupOpen-labelTreatment

Summary

The transition from the Pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . Both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.

Timeline

Start
2016-01
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Degludec Protein / enzyme biologic
Comparator Insulin Lispro Protein / enzyme biologic
Comparator insulin aspart Protein / enzyme biologic
Comparator insulin glargine Protein / enzyme biologic