Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study

Conditions: Type1 Diabetes

Sex: All

Ages: 7 Years – 17 Years

Healthy volunteers: No

Enrollment: 77

Sponsor: Jaeb Center for Health Research

Location: Stanford University Palo Alto California

Summary

The purpose of this extension study is to continue to follow the participants who completed the CLVer RCT for up to 3 additional years. The goal for Cohort A is to evaluate the longer-term effects of verapamil on preservation of β-cell function as measured by C-peptide levels obtained during a mixed meal tolerance test (MMTT). For both Cohorts A and B, the goal is to determine if the high degree of glycemic control achieved during CLVer with HCL can be maintained once the intensive engagement of the study team is discontinued. At the completion of the RCT, study treatments end. Thus, during the extension study, diabetes management is performed as part of usual care and there is no study treatment.

Eligibility Criteria

Completed CLVer RCT 12 month visit and willing to join observational extension.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06177691). StuddyBuddy aggregates publicly available trial information.