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NCT05866536 · ClinicalTrials.gov registry record · Phase 2
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
A Phase 2 study of Diabetes Mellitus and Type 1 Diabetes, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05866536: Recruiting Phase 2 study of Diabetes Mellitus and Type 1 Diabetes, sponsored by Massachusetts General Hospital.
NCT05866536 is a Phase 2 study of Diabetes Mellitus and Type 1 Diabetes that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05866536, a Phase 2 study of Diabetes Mellitus and Type 1 Diabetes, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect in new onset pediatric Type 1 diabetes.
Primary Outcome
A change in hemoglobin A1c (HbA1c) values for new onset pediatric type 1 diabetics compared to self.
Conditions Studied
Interventions
- BIOLOGICAL Bacillus Calmette-Guérin
- BIOLOGICAL Saline Injection
Study Locations (1)
Massachusetts
- Immunobiology Labs CNY 149 - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-05-04 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT05866536 shows while recruiting
NCT05866536 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Bacillus Calmette-Guérin is the first listed.
NCT05866536 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05866536 about?
NCT05866536 is a clinical study titled "Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years". The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect in new onset pediatric Type 1 diabetes.
What is the current status of trial NCT05866536?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2023-05-04. Estimated completion is 2028-05.
What conditions does trial NCT05866536 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1 Diabetes, Autoimmune Diabetes, Diabetes type1.
What interventions are being tested in trial NCT05866536?
The interventions under investigation include: Bacillus Calmette-Guérin (BIOLOGICAL), Saline Injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT05866536?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05866536 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05866536's enrollment target sits among peer trials
100 118th of 208 higher than 86 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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