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

Jaeb Center for Health Research

Status: Active, not recruiting

Conditions: Type1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06177691

CLVerEx

Details and patient eligibility

About

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.

Full description

Participants who complete the CLVer RCT will be eligible to enroll in the CLVer Extension Study. Informed consent and assent, when applicable, will be obtained. Participants will be contacted every 3 months at which time continuous glucose monitoring (CGM) data will be obtained if a CGM device is being used and medical history (including recent point-of-care or local laboratory HbA1c values) will be reviewed; a usual care visit performed by study staff may be considered a study contact. A study visit will occur yearly to update the diabetes and medical history, measure height and weight, determine Tanner staging, download CGM data if available, perform an MMTT, and obtain blood samples for central lab measurement of HbA1c and plasma for storage if consented. Other than the central lab samples, there are no study-specific procedures or data collection that would not be performed as part of standard care.

Enrollment: 77 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

77 participants in 2 patient groups

Cohort A

Description:

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

Description:

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.