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NCT04233034 · ClinicalTrials.gov registry record · Phase 3
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
A Phase 3 study of Type1 Diabetes, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
- 6
- Study locations
NCT04233034 is a Phase 3 study of Type1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 113 participants. The trial reports 6 study locations across 6 states.
The verdict
NCT04233034, a Phase 3 study of Type1 Diabetes, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
- 6
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 119 total studies on file at ClinicalTrials.gov.
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.
NCT04233034 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Connecticut.
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.
What interventions are being tested in trial NCT04233034?
The interventions under investigation include: placebo (DRUG), HCL (DEVICE), verapamil 120mg tablet (DRUG), non-HCL (DEVICE).
Who is sponsoring clinical trial NCT04233034?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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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