MiniMed 670G pivotal in-home hybrid closed-loop study
What this study tests
Pivotal in-home study supporting the first FDA-approved commercial hybrid closed-loop system for type 1 diabetes.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2019-04-16.
Most recent recorded citation date: 2019-01-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adolescents and adults with type 1 diabetes in the pivotal study; pediatric expansion later studied ages 7-13. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- Published pivotal evidence supported safe home use and improved glucose outcomes from baseline. Pediatric follow-on evidence supported expansion down to age 7, with TIR increasing from 56.2% to 65.0% in ages 7-13.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Safety and glucose outcomes during in-home hybrid closed-loop use
The full picture
This is the historical trial lineage for commercial AID: the 670G was not the best algorithm by modern standards, but it established that a hybrid closed-loop system could be used at home safely enough for regulatory approval.
Sources
- [1]Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System · Peer-reviewed study · 2017-03-01
- [2]Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age · Peer-reviewed study · 2019-01-08
- [3]FDA PMA P160017/S031 MiniMed 670G System · Regulatory decision · 2018-06-21