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A One-Year, Multicenter, Non-Interventional, Follow-Up, Safety Study in Subjects Previously Implanted with VC-02TM Combination Product

Recruiting

This is a one-year follow-up study from the parent study; An Open-Label, First-in-Human, Study Evaluating the Safety, Tolerability, and Efficacy of VC-02 Combination Product in Subjects with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness Once a subject completes participation in the parent study with the VC-02 implants and then has all units removed, they will be consented and enrolled into this follow-up study. Clinic visits will occur at the following time points: Day 1, Month 3, Month 6, and Month 12. Visit assessments will include an abbreviated physical exam, vital signs, ultrasound of the areas that were previously implanted, adverse event collection, and limited laboratory assessments. The primary objective is to establish the long-term safety profile of VC-02 through 12 months post-explant. The secondary objective is to evaluate glycemic control following explant.

I'm interested

This study is NOT accepting healthy volunteers

Type 1 Diabetes Mellitus

Cathy Kneeland - kreel001@umn.edu
Melena Bellin
Phase II
STUDY00003133
NCT02939118
See this study on ClinicalTrials.gov

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