Abstract
Background Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes. Methods We present sub-study data from a dual-center, randomized, open-label, two-sequence crossover study in automated insulin delivery naive users, comparing Medtronic MiniMed (R) 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, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers. Results 59/60 people completed the study (mean age 23.3 +/- 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean +/- SE). In adults (>= 18yrs), technology satisfaction favored 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). Adolescents (aged 13-17yrs) also showed a higher DTSQc score during AHCL (n = 16) versus SAP + PLGM (n = 15) (14.8 +/- 0.7 vs 12.1 +/- 0.8, p = 0.024). The DTQ "change" score (n = 59) favored AHCL over SAP + PLGM (3.5 +/- 0.0 vs 3.3 +/- 0.0, p < 0.001). PSQI was completed in those > 16 years (n = 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 +/- 0.3 vs 5.7 +/- 0.3, p = 0.048) with a total score > 5 indicating poor quality sleep. Conclusion These data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.