Current state of impaired awareness of hypoglycaemia (IAH) in people with type 1 diabetes; change in prevalence, impact of glucose monitoring technology and psychosocial impact

Hypoglycaemia is the most frequent complication of insulin treatment in
individuals with type 1 diabetes and a limiting factor for achieving optimal
glycaemic control. Recurrent, hypoglycaemia can induce a process of
habituation, leading to impaired awareness of hypoglycaemia (IAH). In the past
5-10 years, the use of continuous real-time (RT-CGM) or flash glucose
monitoring (FGM) has increased rapidly in people with type 1 diabetes to
improve overall glycaemic control and reduce the frequency of hypoglycaemic
events. So far, there is no evidence that either RT-CGM or FGM improves IAH in
subjects with type 1 diabetes, despite a decrease of severe or sensor-measured
hypoglycaemia. It thus remains to be established whether chronic use of
continuous glucose monitoring devices impacts on the prevalence of IAH in
people with type 1 diabetes. Given a number of changes in clinical care,
including increased use of RT-CGM and FGM as described above, it becomes highly
appropriate to investigate the current state of IAH and severe hypoglycaemia in
type 1 diabetes. Also, since invites to this study will specifically include
people who have taken part of previous assessments, this study wll be able to
investigate the change in IAH over time and the potential contributing role of
RT-CGM/FGM. Furthermore, we want to explore associations of IAH and severe
hypoglycaemia with clinical parameters, quality of life and psychosocial
impact. This knowledge will help people with diabetes and their healthcare
providers to better adjust treatment recommendations to individual targets.

The primary objective is to investigate the current prevalence of IAH and
severe hypoglycaemia (SH) in individuals with diabetes type 1.

The secondary objectives are:
- Study the change of IAH over time in individuals with diabetes type 1.
- Study risk factors associated with change of IAH over time.
- Assess the role of RT-CGM/FGM on (change of) IAH and SH.
- Study thoughts, emotions and worries which lead to a certain behaviour in
case of hypoglycaemia and prevention of hypoglycemia.
- Study associations of IAH and history of SH with productivity in different
situations (work/study, relation/sexuality, driving behaviour/traffic and
sport/leisure).
- Study association between partner involvement and handling in case of
(unawareness for) hypoglycemia.
- Study knowledge of subjects with diabetes about hypoglycemia and IAH.
- Study burden of IAH and severe hypoglycaemia on family members of people with
type 1 diabetes, as experienced by patients themselves.

This study will be a cross-sectional observational cohort study. The study will
be conducted at the Radboud university medical center, department of internal
medicine. Subjects with type 1 diabetes will be recruited from outpatient
diabetes clinic as well as subjects who participated in two earlier cohorts and
agreed to be approached again.

The subjects will not benefit directly from participation to the study.
Irrespective of the outcome of the trial, it will provide useful information
about hypoglycaemia, IAH, benefits of glucose monitoring systems and
psychosocial effects of diabetes, hypoglycaemia and IAH. The results of the
trial will thereby provide physicians and patients new relevant information
towards a better healthcare for the individuals with diabetes. The only risk we
expect in our study is associated with blood sampling. This procedure may lead
to (small) hematomas or temporarily pain, yet these are self-limiting. There
are no other risks.