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Design Considerations for Artificial Pancreas Pivotal Studies
Steven J Russell1, Roy W Beck2
1Diabetes Unit, Massachusetts General Hospital, Boston, MA.
Diabetes Care
|June 23, 2016
Summary
Designing pivotal trials for artificial pancreas systems requires careful consideration of control groups. This perspective discusses using sensor-augmented pump therapy versus usual care for artificial pancreas clinical trials.
Area of Science:
- Biomedical Engineering
- Endocrinology
- Clinical Trial Design
Background:
- Artificial pancreas systems are advancing, necessitating pivotal trials for regulatory approval and clinical adoption.
- Key considerations for these trials include efficacy and safety assessments.
Purpose of the Study:
- To discuss critical aspects of pivotal study design for artificial pancreas systems.
- To explore the choice of control group intervention in these trials.
Main Methods:
- Analysis of control group intervention options for artificial pancreas pivotal trials.
- Discussion of sensor-augmented pump therapy versus usual care as control interventions.
Main Results:
- Pivotal studies for artificial pancreas systems are crucial for FDA clearance, payer coverage, and patient/clinician adoption.
- The choice of control group intervention (sensor-augmented pump therapy vs. usual care) is a significant design consideration.
Conclusions:
- A pragmatic approach to designing clinical trials for artificial pancreas systems is needed.
- The optimal control group intervention requires careful justification based on study goals.
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