The World Awake
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<strong>The</strong> <strong>World</strong><br />
<strong>Awake</strong><br />
A global research report uncovering<br />
the impact of nocturnal hypoglycaemia<br />
on people with diabetes
“<strong>The</strong>se findings suggest<br />
a major education gap<br />
in the area of nocturnal<br />
hypoglycaemia. More<br />
must be done to improve<br />
the dialogue between<br />
people with diabetes<br />
and healthcare<br />
professionals regarding<br />
this serious obstacle to<br />
treatment satisfaction<br />
and wellbeing of<br />
our patients.”<br />
Foreword from<br />
the International<br />
Diabetes Federation<br />
Nocturnal hypoglycaemia is a hidden problem within the diabetes community. Many<br />
people with diabetes experience nocturnal hypoglycaemic events several times a month,<br />
yet research has shown they are often underreported and may go unrecognised. <strong>The</strong>se<br />
night time events can have many implications for those with diabetes, impacting sleep<br />
patterns, quality of life and diabetes self-management. Further, they can be an indicator<br />
of poor glycaemic control and as a result, are a concern for those living with diabetes,<br />
their families and the physicians who treat them.<br />
<strong>The</strong> <strong>World</strong> <strong>Awake</strong> study aims to uncover more information not only on the impact of<br />
having these events, but also worrying about these events, on those living with diabetes.<br />
This report summarises the findings from the study and provides recommendations on<br />
improving the dialogue between those with diabetes and their healthcare professional<br />
to ensure optimal diabetes management.<br />
<strong>The</strong> mission of the International Diabetes Federation (IDF) is to promote diabetes care,<br />
prevention and a cure worldwide. Helping people with diabetes manage their nocturnal<br />
hypoglycaemia is an important step towards improving their health and wellbeing, and<br />
so we are delighted to lend our support to <strong>The</strong> <strong>World</strong> <strong>Awake</strong> campaign.<br />
<strong>The</strong> IDF is an umbrella organisation of over<br />
200 national diabetes associations in over 160<br />
countries. It represents the interests of the<br />
growing number of people with diabetes and<br />
those at risk. <strong>The</strong> Federation has been leading<br />
the global diabetes community since 1950. IDF’s<br />
mission is to promote diabetes care, prevention<br />
and a cure worldwide. www.idf.org<br />
Professor Anthony Barnett, Emeritus Professor of Medicine<br />
and Consultant Physician, University of Birmingham and<br />
Heart of England NHS Foundation Trust, Birmingham, UK<br />
<strong>The</strong> <strong>World</strong> <strong>Awake</strong> study was commissioned by Novo Nordisk A/S and supported by the International Diabetes Federation. Aequus Research<br />
Ltd undertook the quantitative and qualitative research. This report was authored by Michael Gwilt, who was commissioned by Novo Nordisk<br />
with contributions and approval from <strong>The</strong> International Diabetes Federation, Dr Richard Brice (GP with a Special Interest in Diabetes, Kent UK),<br />
Professor Anthony Barnett (Consultant Physician and Emeritus Professor of Medicine, Birmingham UK), Red Health, and Novo Nordisk.<br />
2 3
Contents<br />
Executive summary<br />
Executive summary 5<br />
Introduction: <strong>The</strong> nocturnal hypoglycaemic challenge 7<br />
Nocturnal hypoglycaemia and fear of nocturnal hypoglycaemia<br />
are common in people treated with insulin for their diabetes 8<br />
Frequency of nocturnal hypoglycaemic events 8<br />
Worry about nocturnal hypoglycaemia 9<br />
Having or worrying about nocturnal hypoglycaemia disturbs sleep 11<br />
Impact of having a nocturnal hypoglycaemic event on sleep 11<br />
Impact of worrying about having a nocturnal hypoglycaemic event on sleep 13<br />
Worry about nocturnal hypoglycaemia changes<br />
the way people manage their diabetes 14<br />
Nocturnal hypoglycaemia – the ‘patient-physician consultation’ 17<br />
Nocturnal hypoglycaemia is often not discussed with healthcare practitioners 17<br />
Why are so many people with diabetes reluctant to discuss<br />
nocturnal hypoglycaemia with their primary care physician? 18<br />
Advice from GPs and PCPs on avoiding nocturnal hypoglycaemia 19<br />
Key elements of ‘patient-physician consultations’ for diabetes care 20<br />
Discussion 23<br />
Recommendations for reducing the impact of nocturnal hypoglycaemia on 24<br />
people with diabetes<br />
Appendix: Background on <strong>The</strong> <strong>World</strong> <strong>Awake</strong> research study 25<br />
References 27<br />
<strong>The</strong> <strong>World</strong> <strong>Awake</strong> global research study<br />
was developed to evaluate the impact<br />
of self-treated nocturnal hypoglycaemic<br />
events and the worry that they cause on<br />
the lives of people with diabetes who are<br />
insulin-treated. 1 How people with diabetes<br />
interact with their healthcare practitioners<br />
with regard to nocturnal hypoglycaemia<br />
and its management was also examined.<br />
<strong>The</strong> study was commissioned by Novo<br />
Nordisk A/S and supported by the<br />
International Diabetes Federation (IDF).<br />
Diabetes is one of the most challenging<br />
health problems in the 21st century. <strong>The</strong><br />
number of people with the condition is<br />
increasing in every country worldwide.<br />
People with Type 1 and Type 2 diabetes<br />
who use insulin as part of their<br />
treatment plan are exposed to the risk of<br />
hypoglycaemia (commonly refered to as a<br />
‘hypo’). Hypoglycaemia (abnormally low<br />
blood glucose levels) is often associated<br />
with insulin treatment and the type<br />
and level of activity undertaken by the<br />
individual. 2 Typical symptoms of mild<br />
hypoglycaemia include dizziness, hunger/<br />
thirst, shaking and sweating; more severe<br />
events can cause confusion, disorientation,<br />
coma and death. 3<br />
Nocturnal hypoglycaemia – low blood<br />
glucose events arising at night – has<br />
attracted increasing interest in recent<br />
years as an important source of<br />
morbidity and even mortality in people<br />
with diabetes who are insulin-treated.<br />
Nocturnal hypoglycaemia can be a sign<br />
of uncontrolled diabetes. Much attention<br />
has focussed on severe events, such<br />
as those requiring medical assistance.<br />
However, it has been shown that nocturnal<br />
hypoglycaemic events that people with<br />
diabetes can manage themselves can also<br />
impact quality of life, including quality and<br />
amount of sleep, and the ability to drive<br />
and function at work and home. 4<br />
This study elicited quantitative data from<br />
1,107 individuals using insulin for Type 1 or<br />
Type 2 diabetes from Argentina, Canada,<br />
France, India, Japan, Sweden and the UK,<br />
and solicited qualitative insights into the<br />
experiences of 210 of the participants. 1<br />
All respondents were treated with insulin<br />
and had experienced at least one nocturnal<br />
hypoglycaemic event in the last 30 days.<br />
<strong>The</strong> study was undertaken between July<br />
and September 2013. 1<br />
<strong>The</strong> study explored the impact of nocturnal<br />
hypoglycaemia on sleep patterns,<br />
successful diabetes management (selfmanagement<br />
and through discourse with<br />
their general practitioners (GPs) / primary<br />
care physicians (PCPs) and other healthcare<br />
professionals), and quality of life. 1<br />
<strong>The</strong> study hypotheses were: 1<br />
• Nocturnal hypoglycaemic events<br />
are underreported by people with<br />
diabetes<br />
• People with diabetes may not<br />
always speak to their physician<br />
about these night time events<br />
• Nocturnal hypoglycaemic events<br />
and fear of these episodes have<br />
more impact upon quality of life<br />
than GPs/PCPs and other healthcare<br />
professionals may realise<br />
4 5
Summary of findings 1<br />
• Self-treated nocturnal hypoglycaemia is common.<br />
Overall respondents had experienced an average of three nocturnal hypoglycaemic<br />
events in the previous 30 days a . Over a third of respondents (36%) estimated that they<br />
had experienced between two and six events in the 30 days prior to being surveyed,<br />
and 9% of respondents had experienced more than six nocturnal hypoglycaemic events<br />
Introduction: <strong>The</strong> nocturnal<br />
hypoglycaemic challenge<br />
• People with diabetes worry about nocturnal hypoglycaemia. Over half (55%)<br />
expressed moderate worry and 25% reported significant worry b<br />
• Both the nocturnal hypoglycaemic events themselves and worrying about them<br />
disrupted the sleep of people with diabetes. Symptoms of hypoglycaemia woke<br />
people with diabetes frequently, often leaving them tired, irritable and less able than usual<br />
to function the next day. Three quarters (75%) of those with diabetes reported marked<br />
disturbance of sleep from worrying about nocturnal hypoglycaemia, with 19% reporting<br />
severe sleep disturbance for this reason (score 8–10) c<br />
• Worrying about nocturnal hypoglycaemia changed the way many people managed<br />
their diabetes. 56% of respondents admitted to the worry causing a change in how<br />
they manage their diabetes. Of these, 39% intentionally allowed their blood glucose to<br />
elevate before bed, 39% reduced their insulin intake, 22% changed the timing of insulin<br />
administration and 20% intentionally missed at least one insulin dose<br />
• Many people with diabetes did not discuss their nocturnal hypoglycaemia with<br />
their GP/PCP. Nearly half of all respondents (49%) discussed none of their nocturnal<br />
hypoglycaemic events with their GP/PCP; only 13% discussed all of these events with their<br />
GP/PCP. One in five (20%) did not discuss their nocturnal hypoglycaemic events with any<br />
healthcare professional<br />
• Respondents did not report these nocturnal events for a variety of reasons, most commonly<br />
underestimation of the importance of nocturnal hypoglycaemia; 23% of respondents<br />
who do not discuss any events with their GP/PCP noted that they did not mention the events<br />
as they didn’t feel they were relevant or important enough. Responses to the qualitative<br />
survey suggested that people with diabetes become familiar with nocturnal hypoglycaemia<br />
and confident at managing events without bothering their GP/PCP<br />
Based on the research findings Novo Nordisk A/S, supported by the IDF, will launch <strong>The</strong><br />
<strong>World</strong> <strong>Awake</strong> campaign to educate GPs/ PCPs about the impact of self-treated nocturnal<br />
hypoglycaemia on people with diabetes by: 1<br />
• Raising awareness of the physical and psychosocial impact of nocturnal hypoglycaemia<br />
on those affected and their families<br />
• Encouraging and driving proactive conversations about nocturnal hypoglycaemia,<br />
its management and treatment<br />
A second stage of the campaign will focus on driving awareness of, and understanding<br />
about, the importance of these events among people with diabetes.<br />
Key points:<br />
• Hypoglycaemia is a major barrier<br />
to the management of both Type 1<br />
and Type 2 diabetes<br />
• Nocturnal hypoglycaemia is<br />
common and can have serious<br />
consequences for people with<br />
diabetes<br />
Nocturnal hypoglycaemic events are<br />
common in people with diabetes. <strong>The</strong>se<br />
events affect about half or more of adults<br />
with Type 1 diabetes 5,6 and more than a<br />
third with Type 2 diabetes. 7 Almost half of<br />
hypoglycaemic events in all people with<br />
diabetes occur at night. 8 Previous research<br />
has shown that these events can pose<br />
a particular problem for people with<br />
diabetes, their families and those who treat<br />
them for a number of reasons:<br />
“Reducing the<br />
frequency and<br />
impact of nocturnal<br />
hypoglycaemia is a<br />
major unmet need<br />
in insulin-treated<br />
diabetes.”<br />
<br />
<br />
Sir Michael Hirst, President of the<br />
International Diabetes Federation<br />
• Nocturnal hypoglycaemia does not<br />
usually wake a sleeping person with<br />
diabetes, so the low blood glucose can<br />
go uncorrected 9<br />
• Nocturnal hypoglycaemia reduces<br />
quality of sleep and leaves people with<br />
diabetes tired and feeling unwell the<br />
following day, hence impacting upon<br />
their ability to work productively and<br />
perform routine tasks such as driving 4,10<br />
• People with diabetes fear nocturnal<br />
hypoglycaemia and often allow their<br />
blood glucose to run high towards<br />
bedtime, or change, reduce or even<br />
miss insulin doses 4,10<br />
• Nocturnal hypoglycaemia can be<br />
a major worry for families 5,11,12<br />
• Exercise during the preceding day<br />
can increase the risk of nocturnal<br />
hypoglycaemia, which is an important<br />
barrier to persuading people with<br />
diabetes treated with insulin to adopt<br />
healthy lifestyles 13<br />
a) <strong>The</strong> survey included respondents who had experienced at least one nocturnal hypoglycaemic event in the previous 30 days<br />
b) Moderate/severe worry: rated 3–7/8–10 on a scale from 0 (no worry) to 10 (extreme distress/fear) c) Marked sleep disturbance:<br />
score at least 3; severe sleep disturbance: score 8–10; 0=no impact on sleep, 10=severe insomnia<br />
6 7
Nocturnal hypoglycaemia and<br />
fear of nocturnal hypoglycaemia<br />
are common in people treated<br />
with insulin for their diabetes<br />
Fig.2. Expressions of concern relating to nocturnal hypoglycaemia from the<br />
qualitative survey 1<br />
Less concerning Topic of discussion More concerning<br />
Infrequent, predictable<br />
Mild in impact<br />
Night time low blood<br />
sugar events<br />
More frequent<br />
Less predictable<br />
Greater impact<br />
Key points:<br />
Some events may also go unrecognised. 9<br />
Over two fifths of respondents (44%)<br />
• 36% of respondents reported two believed that they may have experienced<br />
or more self-treatable nocturnal more night time hypoglycaemic events<br />
hypoglycaemic events within the than they realised, and a further 25%<br />
30 days prior to being surveyed were unsure. 1 This finding was strongest in<br />
India, where 64% felt that they may have<br />
• Nocturnal hypoglycaemic events underestimated the number of nocturnal<br />
can go unrecognised; 44% of hypoglycaemic events. 1<br />
respondents believe they may<br />
have experienced more events<br />
than they realised<br />
Fig.1. Average severity of worry about<br />
daytime and night time hypoglycaemia<br />
• 91% of respondents expressed at in the quantitative survey 1<br />
least some degree of worry about<br />
nocturnal hypoglycaemia (score Night time hypoglycaemia<br />
≥1); 77% reported moderate or<br />
significant worry<br />
Frequency of nocturnal<br />
hypoglycaemic events<br />
This study included people with Type 1<br />
or Type 2 diabetes who had experienced<br />
at least one night time low blood glucose<br />
event in the previous 30 days. 1 Over a<br />
quater of respondents (27%) estimated Daytime hypoglycaemia<br />
that they had experienced between two<br />
and six events in the 30 days prior to<br />
being surveyed, and 9% of respondents<br />
had experienced more than six nocturnal<br />
hypoglycaemic events. 1<br />
Overall, about half of all hypoglycaemic<br />
episodes occurred at night (42–56% of<br />
events across our seven countries). 1<br />
Significant<br />
worry<br />
Moderate<br />
worry<br />
Little or<br />
no worry<br />
Definitions according<br />
to scale shown (out of 10):<br />
Significant worry = 8–10<br />
Moderate worry = 3–7<br />
Little worry = 0–2<br />
Results from quantitative<br />
survey<br />
Have experience with<br />
hypos, know what to<br />
expect, what to do<br />
Have spouse/family<br />
Have support<br />
arrangements<br />
Results from qualitative survey<br />
Worry about nocturnal hypoglycaemia<br />
In this study respondents worried about nocturnal hypoglycaemic events to about the<br />
same extent as they did daytime events (Fig.1). 1 In total over three quarters (77%) of<br />
respondents worried about having a nocturnal hypoglycaemic event that they could<br />
treat themselves. 1<br />
<strong>The</strong> qualitative survey showed that overall, irrespective of severity, nocturnal<br />
hypoglycaemic events are worrying to some degree for most people with diabetes<br />
(Fig.2). 1 More episodes of night time hypoglycaemia, less experience of managing them,<br />
and a lower level of support available from family members were all associated with<br />
greater worry about nocturnal hypoglycaemia in the qualitative study. 1 People with<br />
diabetes feared “not being able to wake up or help oneself.” 1<br />
Worrying about nocturnal hypoglycaemia can also impair family life. 1 About one-third<br />
of respondents with a partner or children reported that night time hypoglycaemia had<br />
a more than moderate impact on their relationships with a partner (34%, severe impact<br />
for 18%) or children (30%, severe impact for 16%). d Respondents also reported a strong<br />
emotional response to nocturnal hypoglycaemia in the qualitative survey, expressing<br />
feelings such as: e1<br />
• Fear of death (Argentina, Canada, Japan, UK)<br />
• Anger at nocturnal hypoglycaemia and emptiness (France)<br />
• Falling into a void (Argentina, UK)<br />
Familiarity with low<br />
blood sugar events<br />
• Being trapped (Argentina, France, UK)<br />
Availability of support<br />
Less experience<br />
with hypos<br />
Do not know what to<br />
expect, what to do<br />
No spouse/family<br />
able to help<br />
No or limited support<br />
arrangements<br />
d) Rating of at least 6 (moderate) or 8 (severe) on a scale where 0=no impact and 10=severe impact.<br />
e) Based on qualitative results. Respondents were asked if there was any particular kind of visual imagery that could<br />
capture how they felt about actually having a night time low blood sugar event<br />
8 9
“<strong>The</strong> number of<br />
night time events<br />
patients recognise<br />
may be the tip of the<br />
iceberg. Many people<br />
with diabetes may<br />
be nocturnal hypo<br />
unaware. We must do<br />
more to improve this.”<br />
Having or worrying about<br />
nocturnal hypoglycaemia<br />
disturbs sleep<br />
Key points:<br />
• Waking up with symptoms<br />
(sweating, feeling hot or cold,<br />
shaking, tingling, light-headedness,<br />
feeling unwell) were the most<br />
common alarm signals for nocturnal<br />
hypoglycaemia<br />
• 47% did not record their nocturnal<br />
hypoglycaemic event in any way<br />
• 75% of those who worried reported<br />
that worrying about nocturnal<br />
hypoglycaemia also disturbed sleep<br />
<strong>The</strong> most common symptoms were... 1<br />
Sweats<br />
Feeling<br />
hot or cold<br />
Shaking,<br />
tingling<br />
Lightheadedness<br />
Impact of having a nocturnal<br />
hypoglycaemic event on sleep<br />
Also quite common were... 1<br />
Two thirds (66%) of respondents were<br />
aware that they had experienced a night<br />
time hypoglycaemic event which they could<br />
self-manage due to waking with symptoms<br />
of not feeling well. 1<br />
<strong>The</strong> qualitative survey provided an overview<br />
of the key nocturnal hypoglycaemia<br />
symptoms which caused respondents<br />
to wake 1 .<br />
Headache<br />
‘Not feeling<br />
right’<br />
z z z<br />
Thirst,<br />
hunger<br />
Fatigue<br />
<br />
<br />
Dr Richard Brice, GP with a Special Interest in Diabetes, Kent, UK<br />
10 11
Over two fifths of respondents (47%) did not in any way record any of the<br />
nocturnal hypoglycaemic events which they could self-manage. 1<br />
Of those respondents who did record the event, over half (59%) used a diary or<br />
notepad by their bed. 1<br />
Over half of those surveyed (58%) were aware that they had experienced a night-time<br />
event because they measured their blood glucose on waking. 1 Over one in ten (15%) were<br />
informed they had experienced an event by their partner, friend or housemate. 1<br />
Impact of worrying about having a nocturnal hypoglycaemic<br />
event on sleep<br />
It was found that worrying about nocturnal hypoglycaemia also impaired sleep (Fig.3). 1<br />
Of those respondents who worried about nocturnal hypoglycaemia, three quarters (75%)<br />
noted that this worry adversely affected their sleep with 19% noting a severe impact<br />
or insomnia. f,1<br />
Fig.3. Effect of worrying about self-treatable night time hypoglycaemia on sleep<br />
in the quantitative study of people with diabetes 1<br />
Participants in the qualitative study provided insights into the experience of waking with<br />
a nocturnal hypoglycaemic event: 1<br />
“I sometimes have hypos and wake up, the only manifestation that wakes me<br />
up is that I have the impression I peed on myself that is to say I am totally wet,<br />
I sweat a lot and then I know I have a hypo. I still do a check up but I am rarely<br />
wrong and then I have 0.45 or 0.5, so I get some glucose and go back to bed.”<br />
<br />
Person with Type 2 diabetes, France<br />
“You wake up in the night and you feel different so you know straight away that<br />
your sugars may be low. You feel perhaps a little tingly in the legs, a little numb<br />
in the mouth and a little bit light-headed and hot; sweaty hot; you feel<br />
uncomfortably warm.”<br />
<br />
<br />
Person with Type 2 diabetes, UK<br />
Definitions based on a scale where 0=no impact on sleep and 10=severe impact or insomnia. Little impact<br />
= score 0–2; moderate impact = score 3–7; severe impact = score 8–10. Results from quantitative survey<br />
Impact of nocturnal hypoglycaemia on sleep<br />
All subjects<br />
UK<br />
Sweden<br />
Japan<br />
India<br />
France<br />
More than half of respondents in the qualitative study reported reduced performance<br />
the day after a nocturnal hypoglycaemic event, consistent with the above. 1 Worry about<br />
nocturnal hypoglycaemic events moderately affected overall energy levels in all countries<br />
(average ratings 3.9–6.5/10, on a scale of 0–10). 1<br />
Canada<br />
Argentina<br />
0% 20% 40% 60% 80% 100%<br />
Percentage of respondents who expressed worry about nocturnal hypoglycaemia<br />
“I lose the motivation to be active, and I will tend to spend more time in bed…<br />
even during the day. For whatever I do, for example, cooking a meal or doing<br />
exercise, I can’t act on it spontaneously. I will be more sluggish compared to<br />
other days. It takes more time.”<br />
<br />
Person with Type 2 diabetes, Japan<br />
Severe Moderate Little or none<br />
Those who noted the highest impact of worry on sleep<br />
(severe impact or insomnia, score of ≥8)<br />
• Significantly more respondents in India (41%) vs. respondents in the other survey<br />
countries<br />
• Significantly more respondents with Type 2 vs. Type 1 diabetes (22% vs. 15%)<br />
• Significantly more female vs. male respondents (24% vs. 13%)<br />
f) Ratings of 2 or more and 8 or more where 0=no impact and 10=severe insomnia, respectively<br />
12 13
Worry about nocturnal<br />
hypoglycaemia changes<br />
the way people manage<br />
their diabetes<br />
<strong>The</strong> changes in diabetes management varied across survey countries. 1 <strong>The</strong> top three<br />
actions taken by respondents per country are shown in Fig.4.<br />
Fig.4. <strong>The</strong> three most common actions taken to prevent nocturnal<br />
hypoglycaemia in each country. 1<br />
Argentina<br />
(n=87)<br />
Increased BGM frequency<br />
Changed what I ate throughout the day<br />
Intentionally allowed high glucose level<br />
29%<br />
64%<br />
54%<br />
Key points:<br />
• 56% of those surveyed reported<br />
taking actions to reduce their risk<br />
of nocturnal hypoglycaemia<br />
• Increased frequency of glucose<br />
monitoring and changes to<br />
diet were common strategies to<br />
address worry about nocturnal<br />
hypoglycaemia<br />
• Respondents often changed their<br />
insulin regimens, including<br />
mistimed, reduced or omitted doses<br />
More than half (56%) of respondents<br />
who expressed worry about night time<br />
hypoglycaemia reported that this worry<br />
affected the way in which they managed<br />
their diabetes (46–68% in individual<br />
countries). 1<br />
Worry<br />
affected the<br />
way they<br />
managed their<br />
diabetes<br />
Worry did not<br />
affect the way<br />
they managed<br />
their diabetes<br />
Canada<br />
(n=73)<br />
France<br />
(n=87)<br />
India<br />
(n=101)<br />
Japan<br />
(n=96)<br />
Reduced my insulin dose<br />
Intentionally allowed high glucose level<br />
Changed what I ate throughout the day<br />
Increased BGM frequency<br />
Changed what I ate throughout the day<br />
Reduced my insulin dose<br />
Changed what I ate throughout the day<br />
Increased BGM frequency<br />
Reduced my insulin dose<br />
Increased BGM frequency<br />
Reduced my insulin dose<br />
Intentionally allowed high glucose level<br />
48%<br />
45%<br />
44%<br />
46%<br />
43%<br />
32%<br />
48%<br />
35%<br />
35%<br />
49%<br />
48%<br />
41%<br />
Overall, of those who changed their diabetes management: 1<br />
Increased the frequency of blood<br />
glucose monitoring (BGM)<br />
49%<br />
Sweden<br />
(n=49)<br />
Intentionally allowed high glucose level<br />
Increased BGM frequency<br />
Reduced my insulin dose<br />
61%<br />
59%<br />
49%<br />
Changed what they ate during<br />
the day<br />
Reduced their insulin intake<br />
Intentionally allowed a high<br />
glucose level before bed<br />
42%<br />
39%<br />
39%<br />
UK<br />
(n=77)<br />
Increased BGM frequency<br />
Intentionally allowed high glucose level<br />
Reduced my insulin dose<br />
57%<br />
49%<br />
43%<br />
Increased frequency of BGM could help to improve overall management of diabetes. 14 <strong>The</strong><br />
other actions described above, if taken unilaterally and without the support of a physician,<br />
could impair the control of blood glucose, potentially increasing the likelihood of longterm<br />
disabling complications. 15<br />
Changed the timing of insulin<br />
administration<br />
Intentionally missed at least one<br />
insulin dose<br />
22%<br />
20%<br />
Further responses to the qualitative survey suggested that the worry about nocturnal<br />
hypoglycaemia can lead to people with diabetes feeling self-critical: 1<br />
“Annoying because: have I done anything<br />
wrong? Should I have had that snack? Or why<br />
didn’t I have that snack. If I had it would I have<br />
stopped it? I’m trying to keep control of my<br />
diabetes and it’s very difficult.”<br />
“Why does this happen to me? Why can’t I look<br />
after myself better? And often I know what I can<br />
do and should do. So it feels unfair. I don’t sleep<br />
well, I have a headache, I’m in a bad mood, but<br />
at the same time I’m pleased that I wake up.”<br />
<br />
Person with Type 1 diabetes, UK <br />
Person with Type 2 diabetes, Sweden<br />
14 15
“Fear of nocturnal<br />
hypoglycaemia can<br />
lead to poor treatment<br />
satisfaction, poor<br />
insulin adherence,<br />
and ultimately poor<br />
long-term outcomes<br />
for patients. Physicians<br />
and other healthcare<br />
professionals must<br />
regularly discuss<br />
these events with<br />
their patients.”<br />
Nocturnal hypoglycaemia –<br />
the ‘patient-physician<br />
consultation’<br />
Key points:<br />
• People with diabetes often do not<br />
discuss self-treated nocturnal<br />
hypoglycaemic events with<br />
healthcare practitioners;<br />
- 49% of respondents discussed<br />
none of their night time events<br />
with their GP/PCP<br />
- 20% of respondents did<br />
not discuss their night time<br />
events with any healthcare<br />
professional<br />
• <strong>The</strong> most common reason for not<br />
discussing these events with their<br />
GP/PCP was a feeling that it was<br />
insufficiently important<br />
• <strong>The</strong> most effective consultations<br />
for those with diabetes were<br />
where the physician proposed<br />
practical and effective strategies<br />
to mitigate the impact of nocturnal<br />
hypoglycaemia that fitted with<br />
the person’s specific needs and<br />
limitations<br />
Nocturnal hypoglycaemia is<br />
often not discussed with<br />
healthcare practitioners<br />
Only about one respondent in seven<br />
(13%, 2–24% across countries) discussed<br />
all of their self-treated nocturnal<br />
hypoglycaemia events with their GP/PCP<br />
and almost half (49%, 18–82% across<br />
countries) did not discuss any at all (Fig. 5). 1<br />
Especially high proportions of people with<br />
diabetes in Canada (56%), Japan (57%),<br />
Sweden (82%) and the UK (64%) chose<br />
not to discuss any nocturnal hypoglycaemic<br />
events with their GP/PCP. 1<br />
<strong>The</strong>se findings did not differ according<br />
to type of diabetes: only 10% of<br />
respondents with Type 1 diabetes<br />
and 16% of respondents with Type 2<br />
diabetes discussed all of their nocturnal<br />
hypoglycaemia events with their GP/PCP. 1<br />
Only 23% of all respondents discussed all<br />
of their nocturnal hypoglycaemia events<br />
with their main diabetes specialist, with<br />
lower figures for nurses, pharmacists or<br />
other types of healthcare professional<br />
(4–12%). 1<br />
One in five (20%) respondents did not<br />
discuss their nocturnal hypoglycaemic<br />
events with any healthcare professional. 1<br />
Professor Anthony Barnett, Emeritus Professor of Medicine<br />
and Consultant Physician, University of Birmingham and Heart<br />
of England NHS Foundation Trust, Birmingham, UK<br />
16 17
Fig.5. What proportion of night-time hypoglycaemic<br />
events do respondents discuss with their GP/PCP?<br />
All<br />
Some<br />
None<br />
<strong>The</strong> qualitative survey provided some insights into these findings: 1<br />
“Well, my GP and my Endocrinologist share the same office so I am making the<br />
uninformed assumption that they share the same information.”<br />
<br />
Person with Type 2 diabetes, Canada<br />
“It’s just part of the disease. I can handle it myself. You have to accept it, so I<br />
don’t tend to say anything about it.”<br />
<br />
Person with Type 1 diabetes, Sweden<br />
Why are so many people with diabetes reluctant to discuss<br />
nocturnal hypoglycaemia with their primary care physician?<br />
Results from<br />
quantitative survey 1<br />
Advice from GPs and PCPs on avoiding nocturnal hypoglycaemia<br />
According to respondents, GP/PCPs recommended a range of actions that people with<br />
diabetes could take to minimise the possibility of nocturnal hypoglycaemia in the future<br />
(Fig.7) 1 :<br />
Respondents provided a range of reasons for not discussing any self-treated nocturnal<br />
hypoglycaemic events with their GP or PCP (Fig.6). 1 Overall a lack of awareness or<br />
understanding about the significance of nocturnal hypoglycaemic events among people<br />
with diabetes may explain some of these findings, with nearly a quarter (23%) of<br />
respondents who see their GP/PCP for diabetes stating that they didn’t feel these events<br />
were relevant or important enough to mention. 1 Taken together, these findings suggest an<br />
important need for greater understanding of managing nocturnal hypoglycaemia<br />
effectively, on the part of both physicians and people with diabetes.<br />
Fig.6. Reasons for not reporting nocturnal hypoglycaemic events to GPs/PCPs<br />
Fig.7. What did your GP/PCP recommend?<br />
Keep a diary of how often these events occur<br />
Provide me with general information on how to avoid nocturnal events<br />
Increase blood glucose monitoring<br />
Advised me on how to self-manage these night time events<br />
Eat sugar/a snack before going to bed<br />
36%<br />
33%<br />
32%<br />
30%<br />
29%<br />
Didn’t feel it was relevant/<br />
important enough<br />
23%<br />
Change my evening or night time routines<br />
Reduction in dose of my insulin<br />
27%<br />
22%<br />
Feel my GP/PCP knows/<br />
assumes<br />
Feel like I waste my GP/<br />
PCP’s time<br />
10%<br />
13%<br />
Change the type of insulin I use<br />
Did not recommend anything<br />
Other or don’t know<br />
15%<br />
8%<br />
5%<br />
Forgot<br />
6%<br />
Didn’t have time during<br />
the consultation<br />
Concerned about the<br />
consequences if I reported<br />
I felt embarrassed<br />
5%<br />
5%<br />
5%<br />
Up to 15% of respondents felt that they had come away from the consultation with<br />
no advice on how to better manage their nocturnal hypoglycaemia. 1 Canada had the<br />
greatest number of respondents (15%) and Argentina the lowest (0%) who felt they<br />
received no advice. 1<br />
18 19
Key elements of ‘patient-physician consultations’<br />
for diabetes care<br />
According to respondents, the role of the GP/PCP varied in the different countries. 1 <strong>The</strong><br />
qualitative survey showed that in the UK, a healthcare professional typically raised the<br />
question of hypoglycaemia with people with diabetes. 1 In other countries, people with<br />
diabetes were more likely to instigate such discussions themselves, arising from general<br />
discussions of their well being. 1 A review of a diary may occur, where used (see Fig. 7),<br />
and hypoglycaemia may be discussed in the context of the person’s overall management<br />
of blood glucose (insulin dosage/timings, diet etc). 1 People with diabetes were sensitive to<br />
suggested solutions that fitted into the context of their personal situations. 1<br />
People with diabetes pick up on emotional and practical aspects of their GP/PCP’s<br />
approach (Box 1). 1 Being treated as a partner in the consultation, and not being patronised<br />
or talked down to by the physician, was a common theme. 1 Those with diabetes are often<br />
anxious about meeting the goals agreed with their physician and a requirement for<br />
person-centred care is that healthcare professionals must adopt a non-judgemental<br />
manner when dealing with people with diabetes. 16 Nevertheless, the person with diabetes<br />
is looking for advice or interventions that will address specific problems successfully. 1<br />
Box 1. Emotional and practical domains relating to a successful clinical<br />
consultation, from the perspective of people with diabetes 1<br />
A person with diabetes was typically satisfied with the consultation when: 1<br />
• Questions were answered<br />
• <strong>The</strong> physician’s recommendations improved their well being (“good results“)<br />
• Recommendations were specific to the individual<br />
• <strong>The</strong>y saw the same healthcare practitioner at each visit, especially for hospital-based<br />
personnel<br />
Less satisfying consultations were characterised when: 1<br />
• Recommendations were not new or seen as suitable for a given person<br />
• Advice given was seen as being contradictory or variable advice between different<br />
healthcare practitioners<br />
“It was difficult at first because of the different views the dieticians have from<br />
my own experience. <strong>The</strong> dietician may say that this one is alright and another<br />
dietician will say that this one is not. I have to average the different advice<br />
between the two dieticians to then decide what is best for me.” <br />
<br />
Person with Type 2 diabetes, UK<br />
Emotional<br />
• Approachable, friendly, welcoming<br />
- Good listener, pays attention<br />
- Not too ‘business-like’<br />
• Sympathetic and empathetic<br />
- Not judgmental<br />
- Not (unnecessarily) accusatory,<br />
punishing<br />
• Respectful manner<br />
- Acknowledges expertise/<br />
understanding of the condition<br />
by the person with diabetes<br />
- Not patronising<br />
Results from qualitative survey<br />
Practical<br />
• Spends sufficient time<br />
- Person with diabetes feels they<br />
have had time to discuss issues/<br />
concerns<br />
• Knowledgeable, with<br />
good communication<br />
- Explains well<br />
- Uses terms which person with<br />
diabetes can understand<br />
- Does not read advice off<br />
the computer<br />
• Provides practical (and successful)<br />
solutions to specific problems<br />
- Consistent with other HCPs’ advice<br />
“We can see that nocturnal hypoglycaemia is an important issue for people with<br />
diabetes where they require practical, personalised, high quality advice from<br />
healthcare professionals to help mitigate the frequency and impact of these<br />
episodes. This report gives useful insight into what people need from the doctors<br />
they consult.”<br />
<br />
Dr Richard Brice, GP with a Special Interest in Diabetes, Kent, UK<br />
20 21
“GPs and primary care<br />
physicians are ideally<br />
placed to educate<br />
patients on nocturnal<br />
hypoglycaemia and<br />
help them understand<br />
the significance of<br />
these events.”<br />
Sir Michael Hirst, President of the International Diabetes Federation<br />
Discussion<br />
Having or worrying about nocturnal<br />
hypoglycaemia, of a severity manageable<br />
by those with diabetes themselves, were<br />
common in a typical population of people<br />
with Type 1 or Type 2 diabetes receiving<br />
injections of insulin as part of their<br />
therapeutic management in <strong>The</strong> <strong>World</strong><br />
<strong>Awake</strong> research study. 1<br />
It was clear that both the nocturnal<br />
hypoglycaemic events themselves and<br />
worrying about them influenced the lives<br />
of the people with diabetes in important<br />
ways. 1 For example, having the<br />
hypoglycaemic event frequently woke the<br />
person with diabetes and/or their partner,<br />
especially for men and people with Type 2<br />
diabetes. Sleep disturbance from nocturnal<br />
hypoglycaemia often left them tired and<br />
feeling unwell the next day. 1 Worrying<br />
about the event itself impaired sleep, and<br />
in many cases prompted those with<br />
diabetes to alter their diabetes<br />
management, in particular by missing,<br />
mistiming, or reducing doses of insulin. 1<br />
<strong>The</strong>se actions, if taken unilaterally and<br />
without the support of a physician, could<br />
impair the control of blood glucose and<br />
thus increase the risk of long-term diabetic<br />
complications. 15 Increasing the frequency of<br />
glucose monitoring, on the other hand,<br />
could be one potentially beneficial change<br />
in overall diabetes self-management. 14<br />
<strong>The</strong> <strong>World</strong> <strong>Awake</strong> study also shed light on<br />
the nature of the consultation between the<br />
person with diabetes and their physician. 1<br />
<strong>The</strong>re was no standard method for<br />
reducing the frequency of nocturnal<br />
hypoglycaemia, 1 which is unsurprising given<br />
the complex nature of diabetes and the<br />
need for individualised care. 17-19 However,<br />
the study also showed that a substantial<br />
proportion of people with diabetes were<br />
unable or unwilling to discuss their<br />
nocturnal hypoglycaemia with their GP/<br />
PCP. 1 This barrier to communication came<br />
about for a number of reasons, not least<br />
that the people with diabetes themselves<br />
underestimated the importance of<br />
self-treated nocturnal hypoglycaemia. 1<br />
Overall, a lack of awareness or<br />
understanding about the significance of<br />
nocturnal hypoglycaemic events among<br />
people with diabetes may explain some<br />
of these findings.<br />
This reluctance to discuss nocturnal<br />
hypoglycaemic events represents a serious<br />
problem relating to the delivery of effective<br />
diabetes care for many people with<br />
diabetes. Fear of hypoglycaemia can lead<br />
to poor treatment satisfaction. In turn, this<br />
may promote loss of self-confidence<br />
among people with diabetes and their<br />
physicians. Poor adherence to therapy may<br />
then lead to worsened glycaemic control,<br />
with increased burden of disease (i.e.<br />
likelihood of poor long-term outcomes<br />
and diabetic complications). 15<br />
Accordingly, physicians must work more<br />
effectively with people with diabetes to<br />
ensure that episodes of nocturnal<br />
hypoglycaemia are explored fully.<br />
According to our population, once a<br />
problem with nocturnal hypoglycaemia has<br />
been acknowledged, the GP/PCP needs to<br />
communicate their knowledge of the<br />
problem, and demonstrate their<br />
commitment to providing practical and<br />
effective strategies to mitigate the impact<br />
of nocturnal hypoglycaemia that fit with<br />
the person with diabetes’ specific needs<br />
and limitations. 1<br />
In conclusion, self-managed nocturnal<br />
hypoglycaemia and the worry and fear<br />
it engenders remain a major clinical<br />
challenge in people with diabetes who<br />
are insulin-treated. Increased<br />
awareness and improved dialogue is<br />
needed among people with diabetes<br />
and the physicians who treat them in<br />
order to reduce the substantial impact<br />
of nocturnal hypoglycaemia on the<br />
lives of people with diabetes.<br />
22 23
Recommendations<br />
for reducing the impact of<br />
nocturnal hypoglycaemia<br />
on people with diabetes<br />
from Professor Anthony Barnett, Dr Richard Brice<br />
and the International Diabetes Federation<br />
Based on the findings from <strong>The</strong> <strong>World</strong> <strong>Awake</strong> research study, 1 the following suggestions<br />
are recommended to improve the dialogue between people with diabetes and their<br />
healthcare professional, aiding optimal diabetes management.<br />
Appendix: Background<br />
on <strong>The</strong> <strong>World</strong> <strong>Awake</strong><br />
research study 1<br />
<strong>The</strong> global quantitative research was commissioned and funded by Novo Nordisk A/S and<br />
conducted by Aequus Research Ltd amongst 1,107 adults (over 18 years old) with both<br />
Type 1 and Type 2 diabetes between July and September 2013. All participants were<br />
treated with insulin and had experienced a night time low blood glucose event in the 30<br />
days prior to being surveyed. g<br />
Interviews were conducted in seven countries (Fig.8):<br />
1. Raise awareness among people with<br />
diabetes and their families of the<br />
seriousness of nocturnal hypoglycaemic<br />
events.<br />
All people with diabetes and their family<br />
members should understand that even<br />
self-treated nocturnal hypoglycaemia<br />
can have serious consequences and<br />
steps should be taken to manage and<br />
reduce the incidence of these events.<br />
2. Increase understanding among<br />
healthcare professionals of the physical<br />
and psychosocial impact that selftreated<br />
nocturnal hypoglycaemic events<br />
have on people with diabetes.<br />
All physicians involved in the<br />
management of diabetes should<br />
understand that the impact of having<br />
or the fear of having nocturnal<br />
hypoglycaemia can be a real concern<br />
for people living with diabetes and their<br />
families, disturbing their sleep patterns,<br />
quality of life and the way that they<br />
manage their condition. Failure to<br />
recognise the importance of nocturnal<br />
hypoglycaemia with regards to diabetes<br />
care can have serious therapeutic<br />
implications. If people with diabetes are<br />
dissatisfied with their treatment they<br />
may not adhere well to it. Long-term<br />
loss of glycaemic control would then<br />
increase the likelihood of developing<br />
complications of diabetes that reduce<br />
the quality and duration of lives of<br />
people with diabetes.<br />
3. Encourage and improve proactive<br />
discussion between people with<br />
diabetes and their GP/PCP on the<br />
topic of nocturnal hypoglycaemia.<br />
People with diabetes should report<br />
all nocturnal hypoglycaemic events<br />
to their GP/PCP to allow their<br />
management approaches to be<br />
revised appropriately. Healthcare<br />
professionals should help to prevent<br />
night time events in people with<br />
diabetes by providing practical and<br />
effective strategies that fit with the<br />
person’s specific needs and limitations.<br />
<strong>The</strong>se may include education and<br />
empowerment, increased monitoring<br />
and review of their insulin regimen.<br />
Fig.8. Global reach of <strong>The</strong> <strong>World</strong> <strong>Awake</strong> study<br />
Figures in brackets are the numbers of respondents in each country in the quantitative<br />
survey. Thirty people with diabetes in each country contributed to the qualitative survey.<br />
UK<br />
(170)<br />
Canada<br />
Argentina<br />
g) <strong>The</strong> survey only included respondents taking insulin<br />
(170)<br />
Sweden<br />
France<br />
(173)<br />
(171)<br />
(100)<br />
India<br />
(173)<br />
Japan<br />
(150)<br />
24 25
• A quantitative survey based on 1,107 adult individuals using insulin to manage<br />
their diabetes (536 with Type 1 diabetes and 571 with Type 2 diabetes). Each<br />
respondent conducted a 20-minute online interview<br />
• A qualitative survey conducted using interviews with 210 people with diabetes<br />
(30 respondents from each country) who had participated in the quantitative study,<br />
in order to gain further insight into the impact of hypoglycaemia. Each respondent<br />
completed a 45-minute in-depth telephone interview<br />
<strong>The</strong> participants included were typical of those seen in routine clinical practice in the<br />
primary care setting:<br />
83%<br />
8%<br />
9%<br />
48% had Type 1 diabetes,<br />
52% had Type 2 diabetes<br />
<strong>The</strong> genders were equally<br />
balanced overall – 46%<br />
male vs. 54% female<br />
54%<br />
Most (83%) were aged 25–64 years;<br />
8% were aged 18–24 years and 9%<br />
were aged 65 years or over<br />
Type 1 48%<br />
46%<br />
52% Type 2<br />
• More people with Type 1 diabetes had been using insulin for more than 2 years<br />
(76%) vs. for Type 2 diabetes (50%)<br />
• Types of insulin used: basal (long-acting) only by 23%; bolus (short-acting mealtime<br />
insulin) only in 16%; basal + bolus in 47% and premixed long- and short-acting insulin<br />
in 14%<br />
• More people with Type 1 diabetes (49%) used only insulin to manage their diabetes<br />
compared with those with Type 2 diabetes (26%); 46% of each group said they were<br />
also undertaking a lifestyle intervention (diet and exercise)<br />
References<br />
1. Diabetes <strong>World</strong> <strong>Awake</strong> Study. Conducted by Aequus Research Ltd July – September<br />
2013. Funded by Novo Nordisk<br />
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medlineplus/ency/article/000310.htm Last accessed: October 2013<br />
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665–671<br />
13. Tamborlane WV. Triple jeopardy: nocturnal hypoglycemia after exercise in the young<br />
with diabetes. J Clin Endocrinol Metab 2007; 92(3): 815–816<br />
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15. Shafiee G, Mohajeri-Tehrani M, Pajouhi M, Larijani B. <strong>The</strong> importance of<br />
hypoglycemia in diabetic patients. J Diabetes Metab Disord 2012; 11(1):17<br />
16. Meetoo D, Gopaul H. Empowerment: giving power to people with diabetes.<br />
J Diabetes Nursing 2005; 9: 28–32<br />
17. National Institute for Health and Clinical Excellence (NICE). CG87 Type 2 diabetes -<br />
newer agents (a partial update of CG66). Available at http://guidance.nice.org.uk/<br />
CG87/NICEGuidance/pdf/English Last accessed: October 2013<br />
18. National Institute for Health and Clinical Excellence (NICE). Type 1 diabetes: Diagnosis<br />
and management of type 1 diabetes in children, young people and adults. Available<br />
at http://publications.nice.org.uk/type-1-diabetes-cg15 Last accessed: October 2013<br />
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26 27