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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

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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.

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De-identified data are available from the authors on request.

Abbreviations

AHCL:

Advanced hybrid closed-loop

SAP + PLGM:

Sensor augmented pump therapy with predictive low glucose management

DTSQs and DTSQc:

Diabetes treatment satisfaction questionnaire status and change

DTQ:

Diabetes technology questionnaire

PSQI:

Pittsburgh sleep quality index

WHO-5:

World health organization-five well-being index

HFS-II:

Hypoglycemic fear survey

HCS:

Hypoglycemia confidence scale

AID:

Automated insulin delivery

HCL:

Hybrid closed-loop

CGM:

Continuous glucose monitor

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Acknowledgements

The authors thank the participants and families for taking part in the study.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was financially supported by Medtronic.

Author information

Authors and Affiliations

  1. Southern District Health Board, 201 Great King Street, Dunedin, 9016, New Zealand

    Benjamin J. Wheeler & Niranjala M. Hewapathirana

  2. Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago, 201 Great King Street, Dunedin, 9016, New Zealand

    Benjamin J. Wheeler, Carla M. Frewen, Barbara Galland & Shirley D. Jones

  3. Canterbury District Health Board, 2 Riccarton Avenue, Christchurch Central City, Christchurch, 8011, New Zealand

    Olivia J. Collyns, Denis S. H. Chan & Martin I. de Bock

  4. Christchurch Clinical Studies Trust, Level 4/264 Antigua Street, Christchurch Central City, Christchurch, 8011, New Zealand

    Renee A. Meier & Zara L. Betts

  5. Departent Paediatrics, University of Otago, Terrace House, 4 Oxford Terrace, Christchurch, 8011, New Zealand

    Chris Frampton & Martin I. de Bock

  6. Medtronic, 18000 Devonshire Street, Northridge, CA, 91325, USA

    Anirban Roy, Benyamin Grosman, Natalie Kurtz, John Shin & Robert A. Vigersky

  7. Christchurch Hospital, 2 Riccarton Ave, P.O. Box 3245, Christchurch, 8140, New Zealand

    Martin I. de Bock

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Contributions

RAM, AR, BG, NK, JS, RAV, BJW, and MIdB designed the study protocol. OJC, RAM, ZLB, DSHC, CMF, NMH, SDJ, BJW, and MIdB were involved with recruitment and data collection. BJW, OJC, and MIdB wrote the manuscript. RAM edited the manuscript. CF conducted the statistical analyses. MIdB is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Martin I. de Bock.

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Conflict of interest

B.J.W. and M.I.d.B. are financially supported by Otago University. N.M.H. received honoraria from Sanofi. A.R., B.G., N.K., J.S., and R.A.V. are employees of Medtronic. M.I.d.B. received honoraria from Medtronic. B.J.W. and M.I.d.B have received research funding from Medtronic. No other potential conflicts of interest relevant to this article were reported.

Ethics approval

This study was conducted in compliance with the International Organization for Standardization ISO14155: 2011, and conforms to the provisions of the Declaration of Helsinki. The study was approved by the Southern Health and Disability Ethics Committee and registered at ANZCTR (#12619000007134) and ClinicalTrials.gov (NCT04073576).

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Informed consent was obtained from all participants for inclusion in the study.

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Benjamin J Wheeler and Olivia J Collyns : Joint-First authors.

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Wheeler, B.J., Collyns, O.J., Meier, R.A. et al. 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. Acta Diabetol 59, 31–37 (2022). https://doi.org/10.1007/s00592-021-01789-5

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