Towards a better understanding of the day-to-day impact of hypoglycaemia on quality of life in adults with diabetes: Hypo-RESOLVE Clinical Study

Project title

Towards a better understanding of the day-to-day impact of hypoglycaemia on quality of life in adults with diabetes

Project manager

Uffe Søholm, usoeholm@health.sdu.dk

Project description

Background:
Low blood glucose, known as hypoglycaemia, is a major limitation for achieving optimal blood glucose levels among people diabetes, mainly in those who are using insulin therapy. The symptoms of hypoglycaemia are often unpleasant, and include sweating, trembling, hunger, irritation, but may also lead to complete loss of control and embarrassing situations, seizure or even death. However, fear of experiencing new hypoglycaemic episodes may lead to using lower insulin doses and avoidance of physical activity – thereby raising blood glucose levels and an increasing risk of long-term microvascular and macrovascular complications. Hypoglycaemia can impact various subdomains of quality of life (QoL): including sleep quality, energy levels, mood, social life but also cognitive function and work performance. A key limitation of current literature is that it is based on retrospective questionnaires that both assess past hypoglycaemic episodes and the psychological impact of these episodes, but this type of data collection is likely to lead to substantial recall bias and under-detection of nocturnal hypos and non-severe hypos, so our understanding of the day-to-day impact of hypoglycaemia is therefore still limited.

A way of both reducing the potential recall bias, and at the same time maximizing ecological validity is with use of two other methods of data collection: ecological momentary assessment (EMA), where data is collected multiple times a day when the participants respond to questions on a smart phone, and continuous glucose measurement, where a blinded sensor measures the blood glucose multiple times per hour. This allows researchers to study the impact of non-severe hypos (where the person can self-correct the hypo) and severe hypos (where assistance from others in needed to recover from the hypo) in real world settings.

Objectives:
In this study an EMA smartphone application will be developed and used in a multinational clinical study to help us understand the day-to-day impact of hypoglycaemia on different subdomains of quality of life.

Methods:
The observational cohort study will both use EMA methods and full validated questionnaires to collect data. Further participants will wear a continuous glucose monitoring (CGM) device to measure interstitial glucose, thereby making it possible determine to which extent non-severe or severe hypos impact quality of life.

Perspectives:
The development of a hypoglycaemic-specific instrument to follow day-to-day variance in quality of life could help us, future studies and potentially those in daily clinical work to better understand the current role of hypoglycaemia in diabetes, how it impacts on various subdomains of QoL, and also how the different domains might interact with each other. Results in the current literature are biased (due to recall bias, and under recognition of hypoglycaemia) – this is a huge advantage of EMAs where there are measurements several times per day, and risk of these sort of bias is reduced. It is possible that the EMA in combination with a CGM can also be used by clinicians who aim to support and advise people with diabetes who suffer from recurrent hypoglycaemia.

Start date and expected end date

01.02.2019 - 01.02.2022

Main supervisor

Professor Frans Pouwer, Department of Psychology, SDU

Co-supervisors

Professor Jane Speight, Australian Center for Behavioral Research in Diabetes and School of Psychology, Deakin University, Australia and Department of Psychology, SDU;
Dr. Christel Hendrieckx, Australian Centre for Behavioural Research in Diabetes and Deakin University, Australia;
Dr. Pratik Choudhary, King’s College, London, UK;
Dr. Melanie Broadley, Department of Psychology, SDU

The project is carried out under

INSIDE Research Group, within the framework of The Hypo-RESOLVE Project

Collaborators

SDU and various Hypo-RESOLVE stakeholders

Funding

The project is funded by IMI2 (European Union) and is conducted under the umbrella of the HypoResolve Study, as well as the SDU Faculty of Health Sciences Department of Psychology.

Keywords

Hypoglycaemia, type 1 diabetes, T1DM, type 2 diabetes, T2DM, Ecological momentary assessment, fear of hypoglycaemia, quality of life