OBJECTIVE
<p>To investigate glycemic and psychosocial outcomes with hybrid
closed loop (HCL) versus user-determined insulin dosing with multiple daily
injections (MDI) or insulin pump i.e. standard therapy for most adults with
type 1 diabetes.</p>
<p>RESEARCH DESIGN
AND METHODS</p>
<p>Adults with type 1 diabetes using MDI or insulin pump
without continuous glucose monitoring (CGM) were randomized to 26-weeks HCL
(Medtronic 670G) or continuation of current therapy. The primary outcome was
masked-CGM time-in-range (TIR; 70–180mg/dL) during the final 3 weeks. </p>
<p>RESULTS</p>
<p>Participants were randomized to HCL (<i>n</i>=61) or control (<i>n</i>=59). Baseline
mean (SD) age 44.2(11.7)years; HbA<sub>1c</sub> 7.4(0.9)%, 57(10)mmol/mol; 53%
were women and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26
weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26
weeks) 55% (13%) (difference 15%; 95% CI 11, 19%; <i>p</i><0.0001). For HCL, HbA<sub>1c</sub> was lower (median [95% CI] difference −0.4% [−0.6, −0.2]; −4mmol/mol
[−7, −2]; <i>p</i><0.0001) and diabetes-specific positive well-being higher
(difference 1.2, 95% CI 0.4, 1.9; <i>p</i><0.0048)
without a deterioration in diabetes distress, perceived sleep quality or cognition.
Seventeen (nine device-related) vs. thirteen serious adverse events occurred in
the HCL and control groups respectively.</p>
<p>CONCLUSIONS</p>
<p>In adults with type 1 diabetes 26 weeks of HCL improved TIR,
HbA<sub>1c</sub>
and their sense of satisfaction from managing their diabetes than those
continuing with user-determined insulin dosing and self-monitoring blood
glucose. For most people living with type 1 diabetes globally, this trial
demonstrates that HCL is feasible, acceptable and advantageous.</p>