Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app

Uffe Søholm; Melanie Broadley; Natalie Zaremba; Patrick Divilly; Giesje Nefs; Jill Carlton; Julia K Mader; Petra Martina Baumann; Mikel Gomes; Gilberte Martine-Edith; Daniel J Pollard; Dajana Rath; Simon Heller; Ulrik Pedersen-Bjergaard; Rory J McCrimmon; Eric Renard; Mark Evans; Bastiaan de Galan; Thomas Forkmann; Stephanie A Amiel; Christel Hendrieckx; Jane Speight; Pratik Choudhary; Frans Pouwer; Hypo-RESOLVE consortium

doi:10.1371/journal.pone.0283148

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app

PLoS One. 2023 Mar 17;18(3):e0283148. doi: 10.1371/journal.pone.0283148. eCollection 2023.

Authors

Uffe Søholm^{1

2

3}, Melanie Broadley², Natalie Zaremba³, Patrick Divilly³, Giesje Nefs^{4

5

6}, Jill Carlton⁷, Julia K Mader⁸, Petra Martina Baumann⁹, Mikel Gomes¹⁰, Gilberte Martine-Edith³, Daniel J Pollard⁷, Dajana Rath¹¹, Simon Heller¹², Ulrik Pedersen-Bjergaard^{13

14}, Rory J McCrimmon¹⁵, Eric Renard^{16

17}, Mark Evans¹⁸, Bastiaan de Galan^{19

20

21}, Thomas Forkmann¹¹, Stephanie A Amiel³, Christel Hendrieckx^{22

23}, Jane Speight^{2

22

23}, Pratik Choudhary^{3

24}, Frans Pouwer^{2

22

25}; Hypo-RESOLVE consortium

Affiliations

¹ Medical & Science, Patient Focused Drug Development, Novo Nordisk A/S, Søborg, Denmark.
² Department of Psychology, University of Southern Denmark, Odense, Denmark.
³ Faculty of Life Sciences and Medicine, Department of Diabetes, School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.
⁴ Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, the Netherlands.
⁵ Department of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands.
⁶ National Treatment and Research Center for Children, Adolescents and Adults with Type 1 Diabetes, Rotterdam, The Netherlands.
⁷ School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, United Kingdom.
⁸ Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
⁹ Division of Endocrinology & Diabetology, Medical University of Graz, Graz, Austria.
¹⁰ Digital Therapeutics, Scientific Modelling, Novo Nordisk A/S, Søborg, Denmark.
¹¹ Department of Clinical Psychology, University of Duisburg-Essen, Essen, Germany.
¹² Department of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.
¹³ Department of Endocrinology and Nephrology, Nordsjællands Hospital Hillerød, Hillerød, Denmark.
¹⁴ Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
¹⁵ Systems Medicine, School of Medicine, University of Dundee, Dundee, United Kingdom.
¹⁶ Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.
¹⁷ Institute of Functional Genomics, University of Montpellier, CNRS, INSERM, Montpellier, France.
¹⁸ Welcome Trust-MRC Institute of Metabolic Science and Department of Medicine, University of Cambridge, Cambridge, United Kingdom.
¹⁹ Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.
²⁰ Department of Internal Medicine, Division of Endocrinology and Metabolic Disease, Maastricht University Medical Centre, Maastricht, the Netherlands.
²¹ CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands.
²² School of Psychology, Deakin University, Geelong, Australia.
²³ The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Australia.
²⁴ Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.
²⁵ Steno Diabetes Center Odense (SDCO), Odense, Denmark.

Abstract

Introduction: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes.

Materials and methods: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity.

Results: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales.

Conclusion: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

Copyright: © 2023 Søholm et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Benchmarking
Diabetes Mellitus, Type 1* / drug therapy
Diabetes Mellitus, Type 1* / psychology
Diabetes Mellitus, Type 2* / drug therapy
Diabetes Mellitus, Type 2* / psychology
Humans
Hypoglycemia* / psychology
Insulin
Middle Aged
Mobile Applications*
Psychometrics
Reproducibility of Results
Smartphone
Surveys and Questionnaires

Substances

Insulin

Grants and funding

This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and T1D Exchange, JDRF, International Diabetes Federation (IDF) and The Leona M. and Harry B. Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. Results reflects only the authors’ view and JU is not responsible for any use that may be made of the information it contains. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. JS and CH are supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. GME’s position at King’s College London is funded by a grant from Novo Nordisk. There was no additional external funding received for this study.