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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 Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
- 6
- Study locations
NCT04233034: Completed Phase 3 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.
NCT04233034 is a Phase 3 study of Type 1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 113 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04233034, a Phase 3 study of Type 1 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.
Primary Outcome
The primary outcome is the C-peptide in response to a 2-hour MMTT at 52 weeks. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized 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.
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 |
What the finished NCT04233034 record still lists
NCT04233034 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT04233034 lists 6 locations in 6 states (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: Type 1 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.
Learn More About Clinical Trials
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Where NCT04233034's enrollment target sits among peer trials
113 51st of 198 higher than 148 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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