The Hypo-RESOLVE study is answering this important question
Back in 2018, I wrote this blog about an exciting new study called Hypo-RESOLVE. This 26 million Euro project involves 23 partners. It is funded by the European Union and industry. The aim is to provide new knowledge about hypoglycaemia (hypos or low blood glucose). The work is shared among 8 work packages, each with different aims.
Prof Frans Pouwer and I co-lead work package 6, which is about psychological burden. In other words, are finding out how hypos impact on a person’s well-being and quality of life. This work has been supported by a team of brilliant researchers and PhD candidates, as well as a patient advisory committee. Here is the work package 6 team in March 2019.
We have already shared blogs about two systematic reviews:
Since then, we have published three more reviews. One is about changes in quality of life following low glucose among adults with type 2 diabetes. Another review reports on the impact on family members of adults with type 1 and type 2 diabetes. Finally, one looks at the suitability of measures used to assess the impact of hypos on quality of life. In all this work, we have found that researchers most often assess the impact of hypos on emotional well-being – in particular, fear of hypos. We found no suitable measures of the impact of hypos on quality of life. That is, measuring how hypos affect important aspects of our lives, such as relationships, physical health, sleep, work/studies etc.
So, we have conducted a new, multi-country qualitative study, exploring people’s experiences. We have already shared blogs about two of the studies:
We have more to come about other groups.
We have also conducted a new, multi-country survey: “YourSAY: Hypoglycaemia”. In this study, we tested a new measure, the HIP12. It asks the person to rate how hypos affect 12 aspects of their life. We have published the findings for adults with type 1 diabetes here. Overall, we found:
- Severe hypos, self-treated hypos, and impaired awareness of hypo symptoms, all have a negative impact on quality of life
- The aspects of life affected include leisure activities, physical health, ability to keep fit or be active, sleep, emotional well-being, spontaneity, independence, work/studies, and dietary freedom
- Severe hypos most negatively affect a person’s financial situation
- Self-treated hypos most affect people’s ability to be spontaneous
- Impaired awareness most affects a person’s ability to be independent.
- The impact of hypos on quality of life is related more to their well-being, fear of hypos and confidence in managing hypos, than to the frequency or their awareness of hypos.
Overall, our work suggests that health professionals need to ask about people’s experiences with and worries about hypos. People with diabetes need greater support for managing this challenging aspect of their condition.
Importantly, all the studies above rely on a person’s recall of hypos and how they have affected their quality of life recently. They show that we need studies that track the impact of hypos on quality of life in real time. You may have read about our new Hypo-METRICS app here. We designed it to study the daily impact of hypos. We are now well on the way to seeing some results from this app. It is being used in the Hypo-METRICS study, across 4 countries. It involves 250 adults with type 1 diabetes, and 350 adults with insulin-treated type 2 diabetes. The study is led by Prof Pratik Choudhary (UK). We recruited our final participant in August 2022. We now have over 1 million hours of continuous glucose monitoring data and over 150,000 daily questions completed. You can read about the design of the Hypo-METRICS study here. We will share the findings soon, via this blog.
If you enjoyed reading this, check out our other blogs on hypoglycaemia, glucose technologies and quality of life. There is also a series of 8 podcasts about Hypo-RESOLVE, hosted by the patient advisory committee. Episode 6 focuses on the psychological burden, with Dr Melanie Broadley.
Changes in Quality of Life Following Hypoglycaemia in Adults with Type 2 Diabetes: A Systematic Review of Longitudinal Studies. Matlock K, Broadley M, Hendrieckx C, Clowes M, Sutton A, Heller SR, de Galan B, Pouwer F, Speight J for the Hypo-RESOLVE Consortium. Diabetic Medicine, 2022; 39:e14706
The impact of hypoglycaemia on the quality of life of family members of adults with type 1 or type 2 diabetes – a qualitative systematic review. Valdersdorf Jensen M, Broadley M, Speight J, Scope A, Preston L, Heller S, de Galan B, Pouwer F, Hendrieckx C. Diabetic Medicine, 2021; 38(10): e14666
The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods. Carlton J, Leaviss J, Pouwer F, Hendrieckx C, Broadley M, Clowes M, McCrimmon RJ, Heller SR, Speight J. Diabetologia, 2021; doi.org/10.1007/s00125-021-05382-x
The 12-item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes. Broadley M, Chatwin H, Soeholm U, Amiel S, Carlton J, de Galan B, Hendrieckx C, McCrimmon R, Pouwer F, Speight J. BMJ Open Diabetes Research & Care, 2022;10(4)
The impact of hypoglycaemia on quality of life among adults with type 1 diabetes: Results from “YourSAY: Hypoglycaemia”. Chatwin H, Broadley M, Hendrieckx C, Carlton J, Heller S, Amiel SA, de Galan B, McCrimmon RJ, Pedersen-Bjergaard U, Pouwer F, Speight J on behalf of the Hypo-RESOLVE Consortium. Journal of Diabetes and Its Complications, 2022; 108232
Hypo-METRICS: Hypoglycaemia – MEasurement, ThResholds and ImpaCtS – A multi-country clinical study to define the optimal threshold and duration of sensor-detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: the study protocol. Divilly P, Zaremba N, Mahmoudi Z, Søholm U, Pollard DJ, Broadley M, Abbink EJ, de Galan B, Pedersen-Bjergaard U, Renard E, Evans M, Speight J, Brennan A, McCrimmon R, Mullenborn M, Heller S, Seibold A, Mader JK, Amiel SA, Pouwer F. Choudhary P, Hypo-RESOLVE Consortium. Diabetic Medicine, 2022; 5: e14892Print This Post