Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
Status unconfirmed
Conditions studied: Type1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT06177691
- Run by
- Jaeb Center for Health Research
- People needed
- 77
- Starts
- 2021-05-07
- Expected to finish
- 2025-12-18
- Last updated by the study team
- 2023-12-20
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford University — Palo Alto, California, United States
- Barbara Davis Center — Aurora, Colorado, United States
- Yale University — New Haven, Connecticut, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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