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NCT05403502 · ClinicalTrials.gov registry record · NA
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes
A NA study, sponsored by Tandem Diabetes Care.
- Completed
- Registry status
- NA
- Development phase
- 183
- Enrollment target
NCT05403502: Completed NA study, sponsored by Tandem Diabetes Care.
NCT05403502 is a NA study that has completed, run by Tandem Diabetes Care. The registered enrollment target is 183 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05403502, a NA study, has completed, sponsored by Tandem Diabetes Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 183 participants
- Enrollment target
Study Summary
Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.
Primary Outcome
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
Interventions
- DEVICE t:slim X2 insulin pump with Control-IQ technology 1.5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2023-08-02 |
| Phase | NA |
What the finished NCT05403502 record still lists
NCT05403502 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which t:slim X2 insulin pump with Control-IQ technology 1.5 is the first listed.
NCT05403502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05403502 about?
NCT05403502 is a clinical study titled "Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes". Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.
What is the current status of trial NCT05403502?
This trial is currently completed. It is a NA study. The enrollment target is 183 participants. The study started on 2022-08-31. Estimated completion is 2023-08-02.
What interventions are being tested in trial NCT05403502?
The interventions under investigation include: t:slim X2 insulin pump with Control-IQ technology 1.5 (DEVICE).
Who is sponsoring clinical trial NCT05403502?
This trial is sponsored by Tandem Diabetes Care, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05403502's enrollment target sits among peer trials
183 584th of 2000 higher than 1,417 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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