What the trial was testing
The FLAIR enrolled 126 patients with type 1 diabetes. The study was sponsored by HealthPartners Institute and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The advanced system cut time spent with high blood sugar from 37% to 34% of the day.
Lancet (London, England) · 2021 · NCT03040414
These findings — that less time spent with blood sugar above target during the day — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 126 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with type 1 diabetes, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
The advanced system tested in this trial is not yet FDA-approved. The comparison system (MiniMed 670G) is already available and may be an option for you. Talk to your endocrinologist about automated insulin delivery systems that could help manage your blood sugar levels.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open type 1 diabetes trials
The iLet Experience Study
A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months follow-up.
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.