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

NCT06177691 | Unknown

• 1 other identifier: CLVerEx
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• C-peptide

  The primary outcome is the C-peptide measured during the MMTT annually. This is measured as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min. Peak C-peptide also will be computed.

  Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4

Secondary Outcomes (5)

• HbA1c

  Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4

• CGM Metrics

  6, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4

• Severe hypoglycemia episodes

  Year 4

• Diabetic ketoacidosis events

  Year 4

• Hospitalizations

  Year 4

Study Arms (2)

Cohort A

Participants with body weight ≥30 kg (Cohort A) were randomly assigned in a factorial design during the RCT to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. No interventions were administered during the observational extension.

Cohort B

Participants with body weight \<30 kg (Cohort B) were randomly assigned during the RCT 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL. No interventions were administered during the observational extension.

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants who complete the CLVer RCT 12 month visit. RCT participants were youth aged 7-\<18 years at RCT screening with newly diagnosed stage 3 type 1 diabetes.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Juvenile Diabetes Research Foundation: collaborator
• University of Minnesota: collaborator

Study Sites (6)

Stanford University

Palo Alto, California, 94304, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64111, United States

Location

Study Officials

• Antoinette Moran, MD

  University of Minnesota

  STUDY CHAIR

• Gregory Forlenza, MD

  Barbara Davis Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: May 7, 2021
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

US (6)