Objective
<p>To assess the
efficacy and safety of closed-loop insulin delivery compared with
sensor-augmented pump therapy among older adults with type 1 diabetes.</p>
<h2>Research Design and Methods</h2>
<p>This open-label randomized
(1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented
pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration
≥10 years), using an insulin pump. The primary outcome was continuous glucose
monitoring (CGM) time in range <a>(TIR; 3.9–10.0 mmol/L</a>).</p>
<h2>Results</h2>
<p>Thirty participants
(mean age 67 years [SD 5]; median type 1 diabetes duration 38 years [IQR 20–47])
were randomized, <i>n</i>=15 to each sequence; all completed the trial. The mean
TIR was 75.2% (6.3) during the closed-loop stage and 69.0% (9.1) during the
sensor-augmented pump stage (difference 6.2 percentage points [95% CI 4.4, 8.0];
<i>P</i> <0.0001). All prespecified CGM metrics favored closed loop over
sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM
time <3.9 mmol/L during 24 h/day by 0.5 percentage points (0.3, 1.1; <i>P</i>
= 0.0005) and overnight by 0.8 percentage points (0.4, 1.1; <i>P</i> <0.0001)
compared with sensor-augmented pump. There was no significant difference in HbA<sub>1c</sub>
between closed-loop versus sensor-augmented pump stages (7.3% [7.1–7.5] | 56
mmol/mol [54–59] versus 7.5% [7.1–7.9] | 59 mmol/mol [54–62], respectively; <i>P</i>
= 0.13). Three severe hypoglycemia events occurred during the closed-loop stage
and two occurred during the sensor-augmented pump stage; no hypoglycemic events
required hospitalization. One episode of diabetic ketoacidosis occurred during the
sensor-augmented pump stage; no serious adverse events occurred during the
closed-loop stage.</p>
<h2>Conclusion</h2>
<p>Closed-loop
therapy is an effective treatment option for older adults with long duration type
1 diabetes and no safety issues were identified. These older adults had higher TIR
accompanied by less time below range during closed-loop than sensor-augmented
pump therapy. Of particular clinical importance, closed loop reduced the time spent
in hypoglycemic range overnight. </p>
Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial
