The Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL) study published recently in ‘Diabetes Care’ revealed that closed-loop insulin delivery is more effective than sensor-augmented pump therapy in adults with type 1 diabetes (T1D).
In this open-label, randomized (1:1), crossover trial, the researchers compared 4 months of closed-loop versus sensor-augmented pump therapy. Study participants were aged ≥60 years, with type 1 diabetes duration of ≥10 years, and using an insulin pump. The primary outcome was the continuous glucose monitoring (CGM) time in range (TIR; 70- 180 mg/dL)The closed-loop intervention was a commercial MiniMed 670G system. The closed-loop platform comprised a glucose sensor (Guardian Sensor3) and transmitter (Guardian Link 3) for real-time CGM, an insulin pump (MiniMed 670G) with insulin delivery consumables, and an insulin delivery control algorithm. The comparator was sensor-augmented pump therapy using the same MiniMed 670G system exclusively in its “manual mode”, with CGM alerts and optional low-glucose suspend (without either automated delivery or predictive low-glucose suspend activated).
The results showed that mean TIR was 75.2% during the closed-loop stage and 69.0% during the sensor-augmented pump stage (difference of 6.2 percentage points). All pre-specified CGM metrics favored closed loop over the sensor-augmented pump and the benefits were observed greatest overnight. Closed-loop reduced CGM time <70 mg/dL during 24 h/day by 0.5 percentage points and overnight by 0.8 percentage points compared with sensor-augmented pump. There was no significant difference in HbA1c between closed-loop versus sensor-augmented pump stages.
The study concluded that Closed-loop therapy is an effective treatment option for older adults with long-duration type 1 diabetes, and no safety issues were identified. The participants had higher TIR accompanied by less time below range during closed loop than during sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight.