Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers’ Fear of Hypoglycemia and Improves Their Well-being

Author:

de Beaufort Carine123ORCID,Schierloh Ulrike1,Thankamony Ajay4,Ware Julia45,Wilinska Malgorzata E.5,Fröhlich-Reiterer Elke6,Kapellen Thomas M.78,Rami-Merhar Birgit9,Hofer Sabine E.10,Campbell Fiona M.11,Yong James11,Bocchino Laura E.12,Sibayan Judy12,Lawton Julia13,Roze Stephane14,Fritsch Maria6,Thiele Alena7,Allen Janet M.4,Boughton Charlotte4,Mader Julia K.15,Kollman Craig12,Hovorka Roman45,Pit-ten Cate Ineke M.16,Hovorka Roman,Acerini Carlo L.,Thankamony Ajay,Boughton Charlotte K.,Dovc Klemen,Ware Julia,Musolino Gianluca,Wilinska Malgorzata E.,Allen Janet M.,Hartnell Sara,Ruan Yue,Ashcroft Nicole,Haydock Matthew,Hill Catherine,de Beaufort Carine,Schierloh Ulrike,Fichelle Muriel,Schaeffer Dominique,Fröhlich-Reiterer Elke,Fritsch Maria,Jasser-Nitsche Hildegard,Mader Julia K.,Faninger Kerstin,Kapellen Thomas M.,Bartelt Heike,Thiele Alena,Rami-Merhar Birgit,Berger Gabriele,Blauensteiner Nicole,Gellai Renata,Nagl Katrin,Tauschmann Martin,Cvach Sarah,Katzenbeisser-Pawlik Sonja,Hofer Sabine E.,Abt Daniela,Malik Anita,Lanthaler Barbara,Wenzel Matthias,Campbell Fiona,Yong James,Metcalfe Emily,Allen Majorie,Ambler Sarah,Waheed Saima,Exall Jane,Tulip Joseph,

Affiliation:

1. 1Diabetes & Endocrine Care Clinique Pediatrique, Centre Hospitalier de Luxembourg, Luxembourg, Grand Duchy Luxembourg

2. 2Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-Belval, Grand Duchy Luxembourg

3. 3Department of Pediatrics, Universitair Ziekenhuis Brussel, Free University Hospital, Brussels, Belgium

4. 4Wellcome Trust–Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.

5. 5Department of Paediatrics, University of Cambridge, Cambridge, U.K.

6. 6Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria

7. 7Hospital for Children and Adolescents, University of Leipzig, Leipzig, Germany

8. 8Hospital for Children and Adolescents am Nicolausholz, Bad Kösen, Germany

9. 9Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria

10. 10Department of Pediatrics I, Medical University of Innsbruck, Innsbruck, Austria

11. 11Department of Paediatric Diabetes, Leeds Children’s Hospital, Leeds, U.K.

12. 12Jaeb Center for Health Research, Tampa, FL

13. 13Usher Institute, University of Edinburgh, Edinburgh, U.K.

14. 14Vyoo Agency, Sarl, Lyon, France

15. 15Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria

16. 16Luxembourg Center for Educational Assessment, University of Luxembourg, Esch-Belval, Grand Duchy Luxembourg

Abstract

OBJECTIVE To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers’ well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS We conducted a multinational, open-label, randomized crossover study. Children (age 1–7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization–Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.

Funder

National Institute for Health Research Cambridge Biomedical research Centre

Horizon 2020 Framework Programme

JDRF

Wellcome Strategic Award

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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