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Randomized Controlled Trial
. 2022 Jan;59(1):31-37.
doi: 10.1007/s00592-021-01789-5. Epub 2021 Aug 27.

Improved technology satisfaction and sleep quality with Medtronic MiniMed® Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with Type 1 Diabetes in a randomized crossover trial

Benjamin J Wheeler  1   2 , Olivia J Collyns  3 , Renee A Meier  4 , Zara L Betts  4 , Chris Frampton  5 , Carla M Frewen  2 , Barbara Galland  2 , Niranjala M Hewapathirana  1 , Shirley D Jones  2 , Denis S H Chan  3 , Anirban Roy  6 , Benyamin Grosman  6 , Natalie Kurtz  6 , John Shin  6 , Robert A Vigersky  6 , Martin I de Bock  7   8   9
Affiliations
Randomized Controlled Trial

Improved technology satisfaction and sleep quality with Medtronic MiniMed® Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with Type 1 Diabetes in a randomized crossover trial

Benjamin J Wheeler et al. Acta Diabetol. 2022 Jan.

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 naïve users, comparing 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, 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.

Keywords: Adolescents; Automated insulin delivery; Children; Diabetes; Psychosocial; Sleep; Type 1.

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