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

NCT01680185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-06-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Insulin lispro, Humalog (Eli Lilly) in insulin pump

all covered above

DRUG

Human insulin isophane, Humulin N (Eli Lilly)

all covered above

OTHER

Standard of care

all covered above

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Marcus D Säemann, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01680185 on ClinicalTrials.gov