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Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
NCT04233034 · View on ClinicalTrials.gov ↗
Study Summary
Randomized trial of youth aged 7-\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after diagnosis. Participants with body weight ≥30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight \<30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.
Conditions Studied
Interventions
- DRUG placebo
- DEVICE HCL
- DRUG verapamil 120mg tablet
- DEVICE non-HCL
Study Locations (6)
California
- Stanford University — Palo Alto
Colorado
- Barbara Davis Center — Aurora
Connecticut
- Yale University — New Haven
Indiana
- Indiana University — Indianapolis
Minnesota
- University of Minnesota — Minneapolis
Missouri
- Children's Mercy Hospital — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04233034
The ClinicalTrials.gov registry entry for NCT04233034 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Type1 Diabetes appearing as the primary indexed condition, and to 4 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04233034 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04233034 about?
NCT04233034 is a clinical study titled "Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes". Randomized trial of youth aged 7-\<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of β-cell function 12 months after ...
What is the current status of trial NCT04233034?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2020-07-09. Estimated completion is 2022-09-30.
What conditions does trial NCT04233034 study?
This clinical trial studies the following conditions: Type1 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04233034?
The interventions under investigation include: placebo (DRUG), HCL (DEVICE), verapamil 120mg tablet (DRUG), non-HCL (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04233034?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04233034 being conducted?
This trial has 6 study locations across California, Colorado, Connecticut, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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