- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06177691
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study (CLVerEx)
December 11, 2023 updated by: Jaeb Center for Health Research
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford University
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Colorado
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Aurora, Colorado, United States, 80045
- Barbara Davis Center
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Missouri
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Kansas City, Missouri, United States, 64111
- Children's Mercy Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
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.
Description
Completed CLVer RCT 12 month visit and willing to join observational extension.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-peptide
Time Frame: Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
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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.
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Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
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HbA1c outcomes, measured annually, will include the following:
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Randomization, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
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CGM Metrics
Time Frame: 6, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
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CGM metrics will be computed for each time point of data collection. CGM-derived indices will be computed for 24 hours, daytime (6AM to midnight) and nighttime (midnight to 6AM). The Statistical Analysis Plan (SAP) will describe how CGM derived indices will be calculated. The following metrics will be computed:
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6, 13, 26, 39 weeks, Year 1, Year 2, Year 3, Year 4
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Severe hypoglycemia episodes
Time Frame: Year 4
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Frequency of episodes of severe hypoglycemia by cohort group.
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Year 4
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Diabetic ketoacidosis events
Time Frame: Year 4
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Frequency of episodes of diabetic ketoacidosis by cohort group.
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Year 4
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Hospitalizations
Time Frame: Year 4
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Frequency of hospitalizations by cohort group.
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Year 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Antoinette Moran, MD, University of Minnesota
- Study Chair: Gregory Forlenza, MD, Barbara Davis Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2021
Primary Completion (Estimated)
December 18, 2025
Study Completion (Estimated)
December 18, 2025
Study Registration Dates
First Submitted
December 11, 2023
First Submitted That Met QC Criteria
December 11, 2023
First Posted (Estimated)
December 20, 2023
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLVerEx
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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