NCT06177691Completed
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 77 (actual)
- First submitted
- 11 Dec 2023
- Start date
- 7 May 2021
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Jaeb Center for Health Research
- Diseases
- Type 1 diabetes
- NCT number
- NCT06177691
What you commit to
- Study type: Observational
- Participants enrolled: 77
- From 7 May 2021 to the primary completion date, 31 Mar 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Completed CLVer RCT 12 month visit and willing to join observational extension.
Age in the registry: 7 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barbara Davis Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.