Alessandro Bisio1, Linda Gonder-Frederick1,2, Ryan McFadden1, Daniel Cherñavvsky1, Mary Voelmle1,3, Michael Pajewski1, Pearl Yu4, Heather Bonner4, Sue A Brown1,3. 1. Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA. 2. Department of Psychiatry, University of Virginia, Charlottesville, VA, USA. 3. Department of Medicine, Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA, USA. 4. Department of Pediatrics, University of Virginia, Charlottesville, VA, USA.
Abstract
BACKGROUND: Older adults with type 1 diabetes (≥65 years) are often under-represented in clinical trials of automated insulin delivery (AID) systems. We sought to test the efficacy of a recently FDA-approved AID system in this population. METHODS: Participants with type 1 diabetes used sensor-augmented pump (SAP) therapy for four weeks and then used an AID system (Control-IQ) for four weeks. In addition to glucose control variables, patient-reported outcomes (PRO) were assessed with questionnaires and sleep parameters were assessed by actigraphy. RESULTS: Fifteen older adults (mean age 68.7 ± 3.3, HbA1c of 7.0 ± 0.8) completed the pilot trial. Glycemic outcomes improved during AID compared to SAP. During AID use, mean glucose was 146.0 mg/dL; mean percent time in range (TIR, 70-180 mg/dL) was 79.6%; median time below 70 mg/dL was 1.1%. The AID system was in use 92.6% ± 7.0% of the time. Compared to SAP, while participants were on AID the TIR increased significantly (+10%, P = .002) accompanied by a reduction in both time above 180 mg/dL (-6.9%, P = .005) and below 70 mg/dl (-0.4%, P = .053). Diabetes-related distress decreased significantly while using AID (P = .028), but sleep parameters remained unchanged. CONCLUSIONS: Use of this AID system in older adults improved glycemic control with high scores in ease of use, trust, and usability. Participants reported an improvement in diabetes distress with AID use. There were no significant changes in sleep.
BACKGROUND: Older adults with type 1 diabetes (≥65 years) are often under-represented in clinical trials of automated insulin delivery (AID) systems. We sought to test the efficacy of a recently FDA-approved AID system in this population. METHODS: Participants with type 1 diabetes used sensor-augmented pump (SAP) therapy for four weeks and then used an AID system (Control-IQ) for four weeks. In addition to glucose control variables, patient-reported outcomes (PRO) were assessed with questionnaires and sleep parameters were assessed by actigraphy. RESULTS: Fifteen older adults (mean age 68.7 ± 3.3, HbA1c of 7.0 ± 0.8) completed the pilot trial. Glycemic outcomes improved during AID compared to SAP. During AID use, mean glucose was 146.0 mg/dL; mean percent time in range (TIR, 70-180 mg/dL) was 79.6%; median time below 70 mg/dL was 1.1%. The AID system was in use 92.6% ± 7.0% of the time. Compared to SAP, while participants were on AID the TIR increased significantly (+10%, P = .002) accompanied by a reduction in both time above 180 mg/dL (-6.9%, P = .005) and below 70 mg/dl (-0.4%, P = .053). Diabetes-related distress decreased significantly while using AID (P = .028), but sleep parameters remained unchanged. CONCLUSIONS: Use of this AID system in older adults improved glycemic control with high scores in ease of use, trust, and usability. Participants reported an improvement in diabetes distress with AID use. There were no significant changes in sleep.
Authors: Sue A Brown; Boris P Kovatchev; Dan Raghinaru; John W Lum; Bruce A Buckingham; Yogish C Kudva; Lori M Laffel; Carol J Levy; Jordan E Pinsker; R Paul Wadwa; Eyal Dassau; Francis J Doyle; Stacey M Anderson; Mei Mei Church; Vikash Dadlani; Laya Ekhlaspour; Gregory P Forlenza; Elvira Isganaitis; David W Lam; Craig Kollman; Roy W Beck Journal: N Engl J Med Date: 2019-10-16 Impact factor: 91.245
Authors: Maurice Ohayon; Emerson M Wickwire; Max Hirshkowitz; Steven M Albert; Alon Avidan; Frank J Daly; Yves Dauvilliers; Raffaele Ferri; Constance Fung; David Gozal; Nancy Hazen; Andrew Krystal; Kenneth Lichstein; Monica Mallampalli; Giuseppe Plazzi; Robert Rawding; Frank A Scheer; Virend Somers; Michael V Vitiello Journal: Sleep Health Date: 2016-12-23
Authors: Pierre-Yves Benhamou; Sylvia Franc; Yves Reznik; Charles Thivolet; Pauline Schaepelynck; Eric Renard; Bruno Guerci; Lucy Chaillous; Celine Lukas-Croisier; Nathalie Jeandidier; Helene Hanaire; Sophie Borot; Maeva Doron; Pierre Jallon; Ilham Xhaard; Vincent Melki; Laurent Meyer; Brigitte Delemer; Marie Guillouche; Laurene Schoumacker-Ley; Anne Farret; Denis Raccah; Sandrine Lablanche; Michael Joubert; Alfred Penfornis; Guillaume Charpentier Journal: Lancet Digit Health Date: 2019-05-02
Authors: Fernanda G Amaral; Ariane O Turati; Mark Barone; Julieta H Scialfa; Daniella do Carmo Buonfiglio; Rafael Peres; Rodrigo A Peliciari-Garcia; Solange C Afeche; Larissa Lima; Cristoforo Scavone; Silvana Bordin; Russel J Reiter; Luiz Menna-Barreto; José Cipolla-Neto Journal: J Pineal Res Date: 2014-06-03 Impact factor: 13.007
Authors: Esther Donga; Marieke van Dijk; J Gert van Dijk; Nienke R Biermasz; Gert-Jan Lammers; Klaas van Kralingen; Roel P L M Hoogma; Eleonora P M Corssmit; Johannes A Romijn Journal: Diabetes Care Date: 2010-03-31 Impact factor: 17.152
Authors: Max Hirshkowitz; Kaitlyn Whiton; Steven M Albert; Cathy Alessi; Oliviero Bruni; Lydia DonCarlos; Nancy Hazen; John Herman; Paula J Adams Hillard; Eliot S Katz; Leila Kheirandish-Gozal; David N Neubauer; Anne E O'Donnell; Maurice Ohayon; John Peever; Robert Rawding; Ramesh C Sachdeva; Belinda Setters; Michael V Vitiello; J Catesby Ware Journal: Sleep Health Date: 2015-10-31
Authors: Thomas Danne; Revital Nimri; Tadej Battelino; Richard M Bergenstal; Kelly L Close; J Hans DeVries; Satish Garg; Lutz Heinemann; Irl Hirsch; Stephanie A Amiel; Roy Beck; Emanuele Bosi; Bruce Buckingham; Claudio Cobelli; Eyal Dassau; Francis J Doyle; Simon Heller; Roman Hovorka; Weiping Jia; Tim Jones; Olga Kordonouri; Boris Kovatchev; Aaron Kowalski; Lori Laffel; David Maahs; Helen R Murphy; Kirsten Nørgaard; Christopher G Parkin; Eric Renard; Banshi Saboo; Mauro Scharf; William V Tamborlane; Stuart A Weinzimer; Moshe Phillip Journal: Diabetes Care Date: 2017-12 Impact factor: 19.112
Authors: Benjamin J Wheeler; Olivia J Collyns; Renee A Meier; Zara L Betts; Chris Frampton; Carla M Frewen; Barbara Galland; Niranjala M Hewapathirana; Shirley D Jones; Denis S H Chan; Anirban Roy; Benyamin Grosman; Natalie Kurtz; John Shin; Robert A Vigersky; Martin I de Bock Journal: Acta Diabetol Date: 2021-08-27 Impact factor: 4.280
Authors: Charlotte K Boughton; Sara Hartnell; Hood Thabit; Womba M Mubita; Katharine Draxlbauer; Tina Poettler; Malgorzata E Wilinska; Korey K Hood; Julia K Mader; Parth Narendran; Lalantha Leelarathna; Mark L Evans; Roman Hovorka Journal: Lancet Healthy Longev Date: 2022-03-07
Authors: Eleonora M Aiello; Sunil Deshpande; Basak Ozaslan; Kelilah L Wolkowicz; Eyal Dassau; Jordan E Pinsker; Francis J Doyle Journal: Curr Opin Biomed Eng Date: 2021-06-18