http://www.bmj.com/content/351/bmj.h4612
The National Institute for Health and Care Excellence (NICE) has recommended tighter blood sugar control for patients with diabetes, to minimise the risk of long term vascular complications.
An updated NICE guideline on diagnosing and managing type 1 diabetes in adults recommends a target HbA1c level of 48 mmol/mol (6.5%) or less1: this is lower than the clinical guideline on type 1 diabetes published in 2014, which recommended an HbA1c target of less than 7.5% for prevention of microvascular disease and 6.5% or less in patients at increased risk of arterial disease.2
A target HbA1c target level of 48 mmol/mol (6.5%) or lower is also recommended in children and young people with type 1 or 2 diabetes to minimise the risk of complication
GUIDELINES
Diagnosis and management of type 1 diabetes in
adults: summary of updated NICE guidance
Stephanie A Amiel guideline development group chair, RD Lawrence professor of diabetic medicine1,
Nancy Pursey senior project manager 2, Bernard Higgins clinical director, consultant respiratory
physician 3, Dalia Dawoud health economist, lecturer 4, on behalf of the Guideline Development
Group
1Division of Diabetes and Nutritional Sciences, King’s College London, London, UK; 2National Clinical Guideline Centre, Royal College of Physicians,
London NW1 4LE, UK; 3National Clinical Guideline Centre, Royal College of Physicians, Newcastle upon Tyne Hospitals NHS Foundation Trust,
Newcastle upon Tyne, UK; 4National Clinical Guideline Centre, Royal College of Physicians, Faculty of Pharmacy, Cairo University, Cairo, Egypt
This is one of a series of BMJ summaries of new guidelines based on
the best available evidence; they highlight important recommendations
for clinical practice, especially where uncertainty or controversy exists.
Having type 1 diabetes reduces the life expectancy of adults in
the United Kingdom by as much as 13 years.1 Despite
incontrovertible evidence that good care reduces the risk of
complications such as blindness, renal failure, and premature
cardiovascular disease and death,2 as well as complications of
treatment such as severe hypoglycaemia,3 fewer than 30% of
UK adults with type 1 diabetes achieve current national
treatment targets for glucose control.4 The challenges of
managing type 1 diabetes do not lessen after the age of 18 years.
Since the publication of the 2004 National Institute for Health
and Care Excellence (NICE) guideline, new technologies to
achieve diabetic control have become available—for example,
insulin analogues, new glucose meters, and real time
subcutaneous continuous glucose monitoring systems. The
recent updated NICE guidance aims to support healthcare
professionals and adults with type 1 diabetes to use these
technologies optimally and to individualise targets and treatment
regimens for greater lifestyle flexibility, with clear advice on
education programmes, glucose monitoring, and insulin
preparations.
This article summarises the most recent recommendations from
NICE on the diagnosis and management of type 1 diabetes in
adults.5
Recommendations
NICE recommendations are based on systematic reviews of best
available evidence and explicit consideration of cost
effectiveness. When minimal evidence is available,
recommendations are based on the Guideline Development
Group’s experience and opinion of what constitutes good
practice. Evidence levels for the recommendations based on the
GRADE method6 are given in italics in square brackets.
Diagnosis
• Diagnose type 1 diabetes on clinical grounds:
-Ketosis
-Rapid weight loss
-Age of onset below 50 years
-Body mass index (BMI) below 25
-Personal or family history of autoimmune disease. (New
recommendation.)
• However, do not discount a diagnosis of type 1 diabetes
in people aged 50 years or more or those with a BMI of 25
or above. (New recommendation.)
• In any person of any age or BMI presenting with thirst and
excessive micturition in whom diabetes is suspected,
particularly those with weight loss or nausea, check random
blood glucose and blood or urinary ketones. The presence
of ketonuria or ketonaemia should raise suspicion of type
1 diabetes. Diabetic ketoacidosis (ketonaemia ≥3 mmol/L,
or >2+ ketonuria on strip testing; venous bicarbonate <15
mmol⁄L, or venous pH <7.3, or a combination thereof) is
a medical emergency.7 Lesser degrees of ketosis with
hyperglycaemia (>11 mmol/L) will probably also require
urgent institution of insulin therapy.
• Consider further investigation (measurement of C peptide
or diabetes specific autoimmune antibodies, or both) if
there are atypical features (age ≥50 years, BMI ≥25, slow
evolution of hyperglycaemia, or long prodrome) or
The bottom line
• Offer all adults with type 1 diabetes a structured education programme in self management of diabetes six to 12 months after diagnosis
or, if this was not achieved, at any time that is clinically appropriate and suitable for the person
• Support adults to aim for a target glycated haemoglobin 48 mmol/mol (6.5%) or lower, to minimise risk of vascular complications;
ensure that aiming for the target is not accompanied by problematic hypoglycaemia, and support four to 10 daily self monitoring blood
tests as routine
• Offer all adults daily basal-bolus insulin injection regimens, with twice daily insulin detemir as basal insulin therapy and rapid acting
insulin analogues injected before meals for mealtime insulin “boluses”
• Assess awareness of hypoglycaemia at least annually using a scoring system
How patients were involved in the creation of this article
Patients were involved at every stage of creating the guideline. Patient groups and individuals contributed to the scoping of the update and
at the consultation stage. Lay members were active in the Guideline Development Group, contributing to the formulation of the recommendations
summarised here, and were instrumental in setting the new treatment targets.
uncertainty exists about the type of diabetes. (New
recommendation.)
• [Based on evidence from cross sectional observational
studies and case series and the opinion of the Guideline
Development Group (GDG).]
Education and information
• Offer all adults with type 1 diabetes a structured education
programme in the self management of flexible insulin
therapy (for example the DAFNE (dose adjustment for
normal eating) programme8) six to 12 months after
diagnosis or at any time that is clinically appropriate and
suitable for the person, regardless of duration of type 1
diabetes. Such programmes aim to transfer skills of insulin
dose adjustment to the person with diabetes, enabling
diabetic control with minimal risk of acute complications
of therapy (diabetic ketoacidosis and hypoglycaemia)9 and
long term vascular complications (visual loss, renal failure,
nerve damage, and vascular disease),10 while allowing
flexibility of lifestyle and good quality of life.11 They fulfil
the requirements of structured therapeutic education, which
include evidence of the programme’s efficacy, a written
curriculum, delivery by trained educators, and a quality
assurance programme to ensure consistency and regular
audit of its outcomes.12 (New recommendation.)
• Provide an alternative of equal standard for those not able
to participate in group education and ensure that this
includes the components of structured therapeutic
education. (New recommendation.)
• Carry out a formal review of patients’ ability to manage
their insulin regimen annually, and their need for support
from healthcare professionals, including assessment of
their achievement of glucose targets, their freedom from
problematic hypoglycaemia, and the management of their
risk of complications. (Amended recommendation.)
• [Based on very low to moderate and high quality evidence
from randomised controlled trials (RCTs), the experience
and opinion of the GDG, and a cost-utility study with
potentially serious limitations and direct applicability.]
Dietary management and physical activity
• Offer carbohydrate counting training to adults with type 1
diabetes as part of structured education programmes. (New
recommendation.)
• [Based on very low to moderate quality evidence from
RCTs, observational studies, and the opinion of the GDG.]
• Offer dietary advice about matters other than blood glucose
control, such as weight control and cardiovascular risk
management, as indicated clinically. (New
recommendation.)
• [Based on the opinion and experience of the GDG.]
• Do not advise adults to follow a low glycaemic index diet
for blood glucose control. The GDG found no evidence of
benefit for glycaemic control, frequency of hypoglycaemia,
or quality of life. (New recommendation.)
• [Based on very low to low quality evidence from
randomised and non-randomised controlled trials.]
• Advise adults with type 1 diabetes that physical activity
can reduce their increased cardiovascular risk in the
medium and longer term.
• [Based on evidence from randomised and non-randomised
controlled trials and observational studies in the 2004
NICE guideline (GRADE assessment not performed).]
Blood glucose management
• Measure glycated haemoglobin (HbA1c) every three to six
months, or more often if blood glucose control might be
changing rapidly, and ensure that the result is available at
the time of consultation. (New recommendation.)
• Support adults with type 1 diabetes to aim for a target
HbA1c of 48 mmol/mol (6.5%) or lower to minimise the
risk of vascular complications. (New recommendation.)
• Agree an individualised target based on daily activities,
aspirations, likelihood of complications, comorbidities,
occupation, and history of hypoglycaemia. Most adults
should be supported to aim for the recommended target,
but adjust the numerical value in, for example, frail elderly
patients, and those with limited life expectancy or advanced
vascular complications. Take care to help people in
occupations with a high risk of accidents to avoid
hypoglycaemia; this can be achieved by good education
and, where indicated, use of newer technologies for insulin
delivery and glucose monitoring, although some people
may also need the target to be modified. (New
recommendation.)
• Ensure that aiming for the target is not accompanied by
problematic hypoglycaemia. (New recommendation.)
• [Based on evidence from RCTs, prospective case series
studies, cross sectional observational studies, and an
original economic analysis with potentially serious
limitations but direct applicability.]
Self monitoring of blood glucose
• Advise routine monitoring at least four times a day, before
each meal and before bed. (New recommendation.)
• Support self monitoring up to 10 times a day and enable
more than this if necessitated by the person’s lifestyle.
(New recommendation.)
• Advise patients to aim for a fasting plasma glucose of 5-7
mmol/L before breakfast; 4-7 mmol/L before meals at other
times of day, and, if patients chose to test after meals, 5-9
mmol/L at least 90 minutes after eating. Agree a bedtime
target that accounts for the time of the last meal. (New
recommendation.)
• [Based on low quality evidence from RCTs,
non-comparative observational studies, and an original
economic analysis with potentially serious limitations but
direct applicability.]
• Teach self monitoring skills at diagnosis and educate
patients to interpret and use the results, reviewing their
skills at least annually. (Amended recommendation.)
• Do not recommend routine use of sites other than the
fingertips for testing. (Amended recommendation.)
• Do not routinely offer real time continuous glucose
monitoring (use of subcutaneous sensors for measuring
glucose continuously), but consider it for patients willing
to use it at least 70% of the time if they are experiencing
problematic hypoglycaemia despite optimised use of insulin
(multiple daily injections of insulin or pump therapy) and
conventional monitoring. (New recommendation.)
• [Based on very low to moderate quality evidence from
RCTs, cost-utility studies with potentially serious
limitations and partial applicability, and an original
economic analysis with potentially serious limitations but
direct applicability.]
Insulin therapy
• Offer multiple daily insulin injection basal-bolus regimens,
rather than twice daily mixed insulin regimens. Such
regimens control endogenous glucose production with slow
acting insulins (“basal” insulin), to which fast acting insulin
“boluses” are added before a meal or snack. In flexible
therapy, doses of basal insulin are based on fasting glucose
readings and readings made five or more hours after eating;
doses for meal insulin are based on the current blood
glucose test result and the amount of carbohydrate the
patient plans to eat. All doses can be adjusted prospectively,
after reviewing the effectiveness of doses taken in the past
few days, or to accommodate exercise or other predicted
changes in insulin requirement. Bolus doses of fast acting
insulin can also be used to correct a glucose reading that
is over target.
• Do not offer newly diagnosed patients non-basal-bolus
regimens. (New recommendation.)
• Basal-bolus regimens include:
Basal insulin to control endogenous glucose production:
-Offer twice daily insulin detemir as basal insulin therapy
(New recommendation.)
-As an alternative, consider an existing regimen that is
delivering agreed glucose targets or once daily glargine or
detemir, if the twice daily regimen is not acceptable to the
patient
-Consider other regimens only if the above do not deliver
agreed targets (New recommendation.)
-For guidance on use of continuous subcutaneous insulin
(“pump”) therapy, refer to the NICE technology appraisal.13
(New recommendation.)
• [Based on very low to high quality evidence from RCTs, a
network meta-analysis, cost-utility studies with minor to
very serious limitations and partial or direct applicability,
and an original economic analysis with potentially serious
limitations and direct applicability.]
Bolus insulin to cover ingestion of food (primarily
carbohydrate):
-Offer rapid acting insulin analogues injected before meals
for mealtime insulin replacement (New recommendation.)
-Do not advise routine use of rapid acting insulin analogues
after meals. Delayed injection increases the risk of high
blood glucose immediately after eating (because the glucose
from the food is absorbed before the insulin is active) and
of late hypoglycaemia (because the insulin continues to
act after the food related glucose has gone) (New
recommendation.)
Respect the wishes of the patient in choosing a rapid acting
insulin. (New recommendation.)
• [Based on very low to moderate quality evidence from
RCTs and cost-utility studies with potentially serious
limitations and partial or direct applicability.]
Awareness and management of
hypoglycaemia
• Assess awareness of hypoglycaemia at least annually, using
a scoring system. For example, ask patients to rate their
awareness from 1 (always aware of their hypoglycaemia)
to 7 (never aware of their hypoglycaemia) and consider a
score of 4 or more to indicate impaired awareness with
high risk of severe hypoglycaemia.14
• Ensure that people with impaired hypoglycaemia awareness
receive structured education in flexible insulin therapy
using basal-bolus regimens, and offer additional education
around avoidance and treatment of hypoglycaemia if
needed. (New recommendation.)
• [Based on low quality evidence from observational studies
and the opinion of the GDG.]
• Avoid raising agreed blood glucose targets as a treatment
for impaired awareness of hypoglycaemia and reinforce
recommended targets if the person prefers lower ones.
(New recommendation.)
• First reinforce principles of structured education, then offer
“pump” therapy, and then offer real time glucose
monitoring if impaired awareness of hypoglycaemia
persists. (New recommendation.)
• [Based on very low to moderate quality evidence from
RCTs, cohort studies, and low quality case series.]
Overcoming barriers
Implementing the recommendations will require adequate
resourcing and training of the healthcare workforce to help
healthcare professionals and people with diabetes understand
the importance of glycaemic control; to deliver the mandated
structured education programmes in flexible insulin therapy; to
support glucose self monitoring; and to identify and help patients
who need additional support, including enhanced techniques of
insulin delivery and glucose monitoring (pumps and glucose
sensors). The aim is to help people achieve their targets for
glycaemic control and thereby reduce long term complications,
while avoiding asymptomatic, severe hypoglycaemia, and acute
emergencies, while also optimising quality of life. Solutions
may include creating skilled teams that can deliver education
and psychological support across wide geographical areas, and
greater use of communication technology in delivering
structured education “refresher” courses and accessing specialist
advice on regimen change. More effective monitoring for, and
treatment of, risk factors for long term complications also require
stronger engagement between primary and specialist care, ideally
with access to shared data systems.
Funding: NP, BH, and DD are employed by the Royal College of
Physicians, London at the National Clinical Guideline Centre, which is
commissioned and funded by NICE to develop clinical guidelines. No
authors received specific funding to write this summary.
1 Levin D, Looker HC, Lindsay RS, et al. Scottish Diabetes Research Network epidemiology
group; Scottish Renal Registry. Estimated life expectancy in a Scottish cohort with type
1 diabetes, 2008-2010. JAMA 2015;313:37-44.
2 Writing Group for the DCCT/EDIC Research Group, Orchard TJ, Nathan DM, Zinman B,
et al. Association between 7 years of intensive treatment of type 1 diabetes and long-term
mortality. JAMA 2015;313:45-53.
3 Elliott J, Jacques RM, Kruger J, et al. Substantial reductions in the number of diabetic
ketoacidosis and severe hypoglycaemia episodes requiring emergency treatment lead to
reduced costs after structured education in adults with type 1 diabetes. Diabet Med
2014;31:847-53.
4 National Diabetes Audit 2011-2012. Report 1: care processes and treatment targets.
2014. .www.hscic.gov.uk/catalogue/PUB12421/nati-diab-audi-11-12-care-proc-rep.pdf.
5 National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis
and management. (NICE guideline 17.) 2015. http://www.nice.org.uk/guidance/ng17.
6 What is GRADE? BMJ Clinical Evidence . http://clinicalevidence.bmj.com/x/set/static/ebm/
learn/665072.html.
7 Savage MW, Dhatariya KK, Kilvert A, et al; Joint British Diabetes Societies. Joint British
Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med
2011;28:508-15.
8 DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary
freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE)
randomised controlled trial. BMJ 2002;325:746.
9 Elliott J, Jacques RM, Kruger J, et al. Substantial reductions in the number of diabetic
ketoacidosis and severe hypoglycaemia episodes requiring emergency treatment lead to
reduced costs after structured education in adults with type 1 diabetes. Diabet Med
2014;31:847-53.
10 Kruger J, Brennan A, Thokala P, et al. The cost-effectiveness of the dose adjustment for
normal eating (DAFNE) structured education programme: an update using the Sheffield
type 1 diabetes policy model. Diabet Med 2013;30:1236-44.
11 Hopkins D, Lawrence I, Mansell P, et al. Improved biomedical and psychological outcomes
1 year after structured education in flexible insulin therapy for people with type 1 diabetes:
the UK DAFNE experience. Diabetes Care 2012;35:1638-42.
12 National Institute for Health and Care Excellence. Diabetes in adults quality standard.
2011. www.nice.org.uk/guidance/qs6/chapter/Introduction-and-overview.
13 National Institute for Health and Care Excellence. Continuous subcutaneous insulin
infusion for the treatment of diabetes mellitus. (Technology appraisal guideline 151.) 2008.
www.nice.org.uk/guidance/ta151.
14 Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with
type I diabetes with impaired awareness of hypoglycemia. Diabetes Care 1994l;17:697-703.
15 Diabetes Control and Complications Trial Research Group. The effect of intensive treatment
of diabetes on the development and progression of long-term complications in
insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
16 Hopkinson HE, Jacques RM, Gardner KJ, et al. Twice- rather than once-daily basal insulin
is associated with better glycaemic control in type 1 diabetes mellitus 12 months after
skills-based structured education in insulin self-management. Diabet Med 2015;8:1071-6.
Cite this as: BMJ 2015;351:h4188
© BMJ Publishing Group Ltd 2015
For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
BMJ 2015;351:h4188 doi: 10.1136/bmj.h4188 (Published 26 August 2015) Page 4 of 4
PRACTICE
Further information on the guidance
The National Diabetes Audit showed that targets for glycaemic control were not being met and that regional variations existed in the proportions of patients achieving
these targets, the use of currently available insulins, the availability of accredited structured education programmes, and the proportion of patients using insulin
pumps.4
Some recommendations in the updated guideline may seem aspirational but are necessary to improve clinical outcomes for adults with type 1 diabetes. The tighter
targets for glycaemic control require adequate resourcing and a culture shift in the health service, so that the workforce believes in the importance of achieving these
targets and can support people with diabetes to do so comfortably and safely. The National Institute for Health and Care Excellence (NICE) has developed an
educational tool for healthcare professionals.13 However, even where good structured education has been delivered,5 people may struggle to sustain the strategies
they have learnt.11 Techniques to help deliver sustainable behaviour change may be the key to greater long term success.12
Hypoglycaemia and fear of hypoglycaemia, as well as fear of weight gain, remain barriers to optimal insulin therapy. Yet the evidence is that structured education
programmes reduce severe hypoglycaemia risk even more than glycated haemoglobin (HbA1c).14 Technologies such as pumps and sensors can be beneficial and
their cost effectiveness enhanced if properly used within a care pathway that starts with structured education and adds these technologies as needed to people who
already know how to adjust insulin doses. This ensures that the technologies go first to people who need them most.
Services should document the proportion of patients achieving an HbA1c of 53 mmol/mol (7%) or lower (new recommendation). In the major randomised controlled
trial of intensified versus conventional insulin therapy in people with type 1 diabetes, this is the approximate HbA1c value that was associated with long term benefit
(fewer complications and reduced premature mortality).15 It should be noted that the target for control in this study was 42.6 mmol/mol (6.05%).
What’s new
• Reduction of the HbA1c target from 53 mmol/mol to 48 mmol/mol, with an audit standard of the proportion of people achieving 53 mmol/mol rather than 58
mmol/mol, based on evidence that achieved glycated haemoglobin is always higher than the target set15 4
• Twice daily detemir as the basal insulin regimen of choice, based on a network meta-analysis,5 audit data,16 and original economic analysis5 showing its
effectiveness and cost effectiveness, especially with structured education programmes
• Annual assessment of awareness of hypoglycaemia, based on growing recognition of the increased risk of severe hypoglycaemia in people with impaired
awareness
• More frequent daily routine glucose self monitoring with strips, based on evidence showing better glycated haemoglobin with increased self testing
• Appropriate use of continuous glucose monitoring
Methods
The updated guideline was developed in accordance with NICE guideline methodology (http://publications.nice.org.uk/the-guidelines-manual-pmg6). The Guideline
Development Group (GDG) included diabetologists, nurse and dietitian diabetes educators, patient representatives, a general practitioner, a chemical pathologist,
and a pharmacist, as well as the research and technical staff from NICE. It developed clinical questions and protocols a priori, undertook systematic literature searching,
appraised the evidence, and evaluated cost effectiveness of interventions through review of published evaluations and economic modelling. The quality of the evidence
was assessed using the GRADE methodology (www.gradeworkinggroup.org). The guideline was subject to a rigorous validation process, during which stakeholder
organisations were invited to comment. All comments were considered in producing the final version.
The guideline is available in three formats: a short version; a full version (including all evidence; www.nice.org.uk/guidance/ng17/evidence); and information for the
public for people with type 1 diabetes, their families and carers, and the general public (www.nice.org.uk/guidance/ng17/informationforpublic).
Implementation and costing tools have been developed and are available at the NICE website (www.nice.org.uk/guidance/ng17/resources.)
Further updates of the guidance will be produced as part of NICE’s guideline development programme.
Future research
The GDG prioritised these five research recommendations:
• What methods and interventions are effective in increasing the number of adults with type 1 diabetes who achieve the recommended HbA1c targets without
risking severe hypoglycaemia or weight gain?
• In adults who have chronically poor control of blood glucose levels, what is the clinical and cost effectiveness of continuous glucose monitoring technologies?
• What methods can increase the uptake of structured education programmes and improve their clinical outcomes (particularly achieving and sustaining blood
glucose control targets)?
• Could a risk stratification tool help set individualised HbA1c targets?
• In preventing and treating impaired awareness of hypoglycaemia, what are the most clinically and cost effective technologies (such as insulin pump therapy
or continuous glucose monitoring (or both); partially or fully automated insulin delivery; and behavioural, psychological and educational interventions)? How
are they best used?
Nyhetsinfo
www red DiabetologNytt