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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 />

2. Medline Plus. Drug-induced hypoglycaemia. Available at http://www.nlm.nih.gov/<br />

medlineplus/ency/article/000310.htm Last accessed: October 2013<br />

3. Hamdy O, Srinivasan VAR, Snow KJ. Hypoglycemia Clinical Presentation. Medscape<br />

Reference. Available at http://emedicine.medscape.com/article/122122-clinical Last<br />

accessed: October 2013<br />

4. Brod, M., Pohlman, B., Wolden, M. et al. Non-severe nocturnal hypoglycemic events:<br />

experience and impacts on patient functioning and well-being. Qual Life Res, 2013;<br />

22: 997–1004<br />

5. Allen KV, Frier BM. Nocturnal hypoglycemia: clinical manifestations and therapeutic<br />

strategies toward prevention. Endocr Pract. 2003; 9(6): 530–543<br />

6. Ahmet A, Dagenais S, Barrowman NJ, Collins CJ, Lawson ML. Prevalence of nocturnal<br />

hypoglycemia in pediatric type 1 diabetes: a pilot study using continuous glucose<br />

monitoring. J Pediatr 2011; 159: 297–302<br />

7. Rosenstock J, Dailey G, Massi-Benedetti M, et al. Reduced hypoglycemia risk with<br />

insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in<br />

type 2 diabetes. Diabetes Care 2005; 28(4): 950–955<br />

8. <strong>The</strong> DCCT Research Group. Epidemiology of severe hypoglycemia in the diabetes<br />

control and complications trial. Am J Med 1991; 90: 450–459<br />

9. Schultes B, Jauch-Chara K, Gais S et al. Defective awakening response to nocturnal<br />

hypoglycemia in patients with type 1 diabetes mellitus. PLoS Med 2007; 4: e69<br />

10. King P, Kong MF, Parkin H et al. Well-being, cerebral function, and physical fatigue<br />

after nocturnal hypoglycemia in IDDM. Diabetes Care 1998; 21(3): 341–345<br />

11. Marrero DG, Guare JC, Vandagriff JL, Fineberg NS. Fear of hypoglycemia in the<br />

parents of children and adolescents with diabetes: maladaptive or healthy response?<br />

Diabetes Educ 1997; 23(3): 281–286<br />

12. Brod M., Christensen, T., Thomsen, T.L. et al., <strong>The</strong> impact of non-severe hypoglycemic<br />

episodes on work productivity and diabetes management. Value Health. 2011; 14(5):<br />

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 />

14. American Diabetes Association. Standards of Medical Care in Diabetes–2013.<br />

Diabetes Care 2013;36 Supplement 1:S11–S66<br />

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 />

19. Schechter CB, Walker EA. Improving adherence to diabetes self-management<br />

recommendations. Diabetes spectrum 2002; 15: 170–5<br />

26 27

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