drugset / Trial / NCT01680185
Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Human insulin isophane | Unknown | — | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |