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

NCT06177691 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2023-12-20

No results posted yet for this study

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.

Conditions

  • Type1 Diabetes

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Antoinette Moran, MD · University of Minnesota

  • Gregory Forlenza, MD · Barbara Davis Center

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2025-12-18
Completion
2025-12-18

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06177691 on ClinicalTrials.gov