drugset / Trial / NCT01680185

Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation

NCT01680185

Phase 3 Completed 85 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelPrevention

Summary

The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment with short acting insulin, applied continuously through an insulin pump, (i) improves glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection, in comparison to the standard of care control group, and the basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic events. Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.

Timeline

Start
2012-08
Primary completion
2018-05
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Human insulin isophane Unknown
Comparator Insulin Lispro Protein / enzyme biologic Subcutaneous

Indications