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This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.
This is a 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.
This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).