OBJECTIVE To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability. RESEARCH DESIGN AND METHODS This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery–naive participants with type 1 diabetes (aged 7–80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM). Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout. RESULTS The study was completed by 59 of 60 people (mean age 23.3 ± 14.4 years). Time in target range (TIR) 3.9–10 mmol/L (70–180 mg/dL) favored 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 ± 16.2 mg/dL) and improved with AHCL (8.5 ± 0.7 mmol/L [153 ± 12.6 mg/dL], P < 0.001), but deteriorated during PLGM (9.5 ± 1.1 mmol/L [17 ± 19.8 mg/dL], P < 0.001). TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared with 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 (<3.9 mmol/L [70 mg/dL] and ≤3.0 mmol/L [54 mg/dL]) was 3.1 ± 2.1% and 0.5 ± 0.6%, respectively. During AHCL, the percentage time at <3.9 mmol/L (70 mg/dL) improved to 2.1 ± 1.4% (P = 0.034) and was statistically but not clinically reduced for ≤3.0 mmol/L (54 mg/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 with SAP + PLGM. A lower algorithm SG set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.

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>

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Background: The Medtronic Minimed® Advanced Hybrid Closed-Loop system (AHCL) includes an individualised algorithm with optional set points, automated correction bolus, and improved SmartGuard™ Auto Mode stability. Methods: This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve participants (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). Overall time in target range (TIR) (70-180mg/dL) favoured AHCL over SAP+PLGM by 12.5±8.5% (p&lt;0.001), with greater improvement overnight (15.7±12.0%, p&lt;0.001) (Table 1). This was primarily due to reduction in hyperglycemia (-12.1±9.0% time spent &gt;180mg/dL). Mean SG improved in AHCL by 10.0±7.4mg/dL (p&lt;0.001). For each 1% lower baseline TIR, there was a 0.5% greater TIR improvement with AHCL (p&lt;0.001). Auto Mode was active for 95.3±3.6% of the time. Conclusion: AHCL with automated correction bolus showed significant improvement in glucose control compared to PLGM, in a population with a younger mean age reflecting a challenging demographic. Disclosure O. Collyns: None. R. Meier: None. Z. Betts: None. D. Chan: None. C. Frampton: None. C.M. Frewen: None. B. Grosman: Employee; Self; Medtronic. N. Hewapathirana: Other Relationship; Self; Sanofi. S. Jones: None. N. Kurtz: Employee; Self; Medtronic. A. Roy: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. B.J. Wheeler: Research Support; Self; Medtronic. M. de Bock: None.

Background: Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes. Methods: This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve users, compared Medtronic Minimed® Advanced Hybrid Closed Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). At the end of each 4 week intervention impacts on quality of life were compared using age-appropriate scales: Diabetes Treatment Satisfaction Questionnaire status and change (DTSQs and DTSQc), Diabetes Technology Questionnaire (DTQ), Pittsburgh Sleep Quality Index (PSQI), World Health Organisation-Five Well-Being Index (WHO-5), Hypoglycemic Fear Survey (HFS-II) and Hypoglycemia Confidence Scale (HCS). Results: 59/60 people completed the study (mean age 23.3±14.4yrs). Statistically significant differences favouring AHCL were demonstrated in several scales (data shown as mean±SE). Technology satisfaction favoured AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n=28) vs. SAP+PLGM (n=29) (30.9±0.7 vs. 27.9±0.7, p=0.004) and DTSQc AHCL (n=29) vs. SAP+PLGM (n=30) (11.7±0.9 vs. 9.2±0.8, p=0.032) in adults. Adolescents also showed a higher DTSQc score during AHCL (n=16) vs. SAP+PLGM (n=15) (14.8±0.7 vs. 12.1±0.8, p=0.024). The DTQ “change” score (n=59) favoured AHCL over SAP+ PLGM (3.5±0.0 vs. 3.3±0.0, p&lt;0.001). Improved sleep quality was demonstrated by the lower PSQI in those aged over 16 years (n= 36) during AHCL vs. SAP+PLGM (4.8±0.3 vs. 5.7±0.3, p=0.048) with &gt; 5 indicating poor quality sleep. No differences were found in the other scales. Conclusion: The findings from this RCT suggest AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D. Disclosure O. Collyns: None. R. Meier: None. Z. Betts: None. D. Chan: None. C. Frampton: None. C.M. Frewen: None. B. Galland: None. N. Hewapathirana: Other Relationship; Self; Sanofi. S. Jones: None. N. Kurtz: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic. B.J. Wheeler: Research Support; Self; Medtronic. M. de Bock: None.