Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes
To study the MiniMed™ Advanced Hybrid Closed-Loop system (AHCL) which includes
an algorithm with individualised basal target set points, automated correction
bolus function, and improved Auto Mode stability.
Research design and Methods:
This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve participants with type 1 diabetes (aged 7-80yrs), compared AHCL to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). Each study phase was 4 weeks, preceded by a 2-4 week run-in, and separated by 2-week washout.
Results:
59/60 people completed the study (mean age 23.3±14.4yrs). Time in target range
(TIR) 3.9-10mmol/L (70-180 mg/dL) favoured AHCL over SAP+PLGM (70.4±8.1 vs 57.9±11.7) by
12.5±8.5% (p<0.001), with greater improvement overnight (18.8±12.9%,
p<0.001). All age groups (children (7 – 13 years), adolescents (14 – 21
years), and adults (>22 years) demonstrated improvement, with adolescents
showing the largest improvement (14.4±8.4%). Mean sensor glucose (SG) at run in
was 9.3±0.9 mmol/L (167±16.2mg/dL) and improved with AHCL (8.5±0.7mmol/L (153±12.6mg/dL)
(p < 0.001)), but deteriorated during PLGM (9.5±1.1mmol/L (17±19.8mg/dL),
(p<0.001)).. TIR was optimal when the algorithm set point was 5.6 mmol/L
(100 mg/dL) compared to 6.7 mmol/L (120 mg/dL), 72.0±7.9% vs 64.6±6.9%
respectively with no additional hypoglycemia. Auto Mode was active 96.4±4.0% of
the time. The percentage of hypoglycemia at
baseline (<3.9mmol/L (70mg/dl) and £
3.0mmol/L(54mg/dl)) was 3.1±2.1% and 0.5±0.6%
respectively. During AHCL percentage time <3.9mmol/L (70mg/dl) improved to 2.1±1.4% (p=0.034) (70mg/dl), and was
statistically but not clinically reduced for £ 3.0mmol/L(54mg/dl) (0.5±0.5%, p = 0.025) There
was one episode of mild diabetic ketoacidosis attributed to an infusion set
failure in combination with an intercurrent illness, which occurred during the
SAP+PLGM arm.
Conclusions
AHCL with automated correction bolus demonstrated significant improvement in glucose control compared to SAP+PLGM. A lower algorithm sensor glucose set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.
