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

NCT ID: NCT06177691

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-07

Study Completion Date

2025-12-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoinette Moran, MD

Role: STUDY_CHAIR

University of Minnesota

Gregory Forlenza, MD

Role: STUDY_CHAIR

Barbara Davis Center

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Barbara Davis Center

Aurora, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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CLVerEx

Identifier Type: -

Identifier Source: org_study_id