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<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 > 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.
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.