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

Abstract

Objective:<br><p> 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.<br> Research design and Methods:</p> <p>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.</p> <p><a>Results:<b> </b><br> 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 (</a>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. <a>The percentage of hypoglycemia at baseline (<3.9mmol/L (70mg/dl) and </a> £ 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.</p> <p>Conclusions</p> <p>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.</p>

Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial

“…The improvement in time with glucose in target range in the full cohort (by 6•7 percentage points), where closed-loop usage was low, is similar to that reported in a recent study 15 in children and adolescents with similar baseline HbA 1c comparing the 670G hybrid closed-loop system with standard care over 6 months (improvement by 6•7 percentage points). In the CamAPS FX cohort, where closed-loop usage was consistently high, the improvement in time with glucose in target range (by 15•0 percentage points) compared well with the improvements observed in recent studies comparing the 780G and Control IQ hybrid closed-loop systems with sensor-augmented pump therapy, 5,6,16,17 in which closedloop usage was similarly high. However, comparisons should be interpreted cautiously given differences in study design, frequency of visits, and baseline characteristics.…”

Effectiveness of a closed‐loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: A prospective, multicentre, real‐life study

“…A randomized trial of two hybrid closed‐loop systems, the 670G system and the 670G system with an investigational advanced hybrid closed‐loop system, in adolescents and young adults with type 1 diabetes, showed a significant improvement in TIR from 63% ± 8% to 67% ± 8% 14 . A randomized, crossover study of the 670G system used as predictive low glucose management and the Minimed 780G, similarly reported an improvement in TIR from 57.9% ± 11.7% to 70.4% ± 8.1% 15 . Similar to the clinical trial comparing children treated with SAP and Control‐IQ, 2 we also found that the beneficial effect of Control‐IQ was more evident overnight than during the day.…”

Use of intermittently scanned continuous glucose monitoring in young people with high‐risk type 1 diabetes—Extension phase outcomes following a 6‐month randomized control trial

“…This approach highlights that this device alone is not enough to improve glycaemic control in complex populations and likely needs sustained high levels of education and support offered by the multidisciplinary paediatric diabetes team 26 to achieve healthier diabetes outcomes. As new diabetes technologies emerge, such as advanced automated insulin delivery, 27,28 there remains hope that the lived experience of type 1 diabetes for our most vulnerable young people may also improve. A further limitation of this study is the lack of blinded baseline CGM data (e.g.…”