iDCL / DCLP3
Six-Month Randomised Trial of a Closed-Loop System in Type 1 Diabetes
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 168 patients aged 14–71 with type 1 diabetes, hybrid closed-loop insulin delivery (Control-IQ) improved time-in-range and HbA1c compared with sensor-augmented pump therapy.
N
168
Design
Open-label RCT, 6 mo
Endpunkt
Time in 70–180 mg/dL range
Relevanz
3
ErgebnisTime-in-range 71 % vs 59 % (+11 pp; p<0.001); HbA1c difference −0.3 %; no severe hypoglycaemia.
Brown SA, et al. N Engl J Med. 2019;381(18):1707-1717. 10.1056/NEJMoa1907863
Diskussion & Kritik
Basis of the FDA clearance of Control-IQ — hybrid closed-loop systems are now standard of care for T1DM in many countries.