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

 

Novo Nordisk has given up on the GLP-1 drug as a treatment for Type 1 diabetes, at least for now. A blockbuster in the Type 2 form of the disease, Victoza fell short in a new late-stage trial as an add-on to insulin therapy.

Higher doses of the drug did cut blood sugar levels and helped patients lose weight, but they also boosted the risk of hypoglycemia, Novo said. The lowest dose failed to beat placebo at controlling blood sugar or triggering weight loss.

Together with the results of a previous Type 1 trial, the latest data underwhelmed Novo execs. The company "does currently not intend to submit an application to expand the label of Victoza for use in type 1 diabetes," Novo said in a statement.

Novo's Mads Krogsgaard Thomsen

"We are disappointed as we believed in the potential to provide people with type 1 diabetes with a new treatment option, and we will continue to invest in new treatment options for this group of people," said Mads Krogsgaard Thomsen, Novo's EVP and chief science officer.

From http://www.fiercepharmamarketing.com

Nyhetsinfo

www red DiabetologNytt

Press release

En internationell studie med mer än 7 000 deltagare visar att läkemedlet Jardiance minskar risken att drabbas av hjärt-kärlhändelser hos patienter med typ 2-diabetes. Runt hälften av alla dödsfall i patientgruppen orsakas av hjärt- kärlsjukdomar. De fullständiga resultaten presenteras den 17 september vid EASD-mötet, en stor europeisk diabeteskonferens, i Stockholm.

Patienterna i studien behandlades antingen med Jardiance (empagliflozin) plus standardbehandling för att sänka blodsocker, blodtryck och kolesterol, eller standardbehandling plus placebo. Patienterna följdes upp i genomsnitt drygt tre år. Resultaten visar att antalet hjärt-kärlhändelser, såsom hjärtinfarkt, stroke och död på grund av hjärt-kärlsjukdom, var färre hos dem som fick Jardiance som tillägg till standardbehandling.

De kompletta resultaten presenteras torsdagen den 17 september i Stockholm under EASD-konferensen som pågår 14-18 september. EASD står för European Association for the Study of Diabetes.

– Patienter med diabetes har en fördubblad risk att drabbas av stroke eller hjärtinfarkt varför det länge har varit angeläget att finna en behandling som minskar denna risk. Det här är den första studien i sitt slag på flera tusen patienter som visar att ett läkemedelsom sänker blodsockret även minskar patienternas risk att drabbas av hjärt-kärlhändelser. Dessa resultat kan därför få stor betydelse, men vi vet mer när vi sett de detaljerade resultaten som presenteras i Stockholm den 17 september, säger Mattias Wieloch, kardiolog och medicinsk rådgivare vid Boehringer Ingelheim.

Omkring 350 000 personer i Sverige beräknas ha diabetes typ 2 och mellan 10 och 20 procent av befolkningen över 65 år, enligt Diabetesförbundet.

Ulrika Edvinsson, pressansvarig, Boehringer Ingelheim AB
Charlotte Luderowski, medicinskt ansvarig, Boehringer Ingelheim AB

 

Nyhetsinfo

www red DiabetologNytt

Dexcom had put a bit of a Band-Aid on its mobile strategy--its prior smart device-compatible continuous glucose monitor required a separate worn transmitter and a dedicated handheld receiver.

But now the FDA has approved the first CGM system, dubbed G5, which connects an all-in-one adhesive sensor/transmitter combo directly to an app on a smart device.

The new system will launch in late September with initial compatibility with Apple's iOS; Android compatibility is slated for early next year. In the G5 iteration, there is no additional hardware to facilitate the wireless data transfer between the adhesive CGM and Dexcom's Share analytical and data sharing app, although the system can be used with a dedicated receiver instead of a smart device if the user opts to do so.

"Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3 2015 earnings call in early November," said Dexcom President and CEO Kevin Sayer in a statement.

The G5 system is a big leap forward in terms of simplicity and ease-of-use for diabetic patients. The FDA approved it for adults as well as children as young as two-years-old. Dexcom has always had an edge with younger patients, who are most receptive to cutting-edge technology and whose parents require a way to remotely monitor glucose levels. The G5, like its predecessor, the G4, enables the user to share blood glucose data with up to 5 recipients, which can include healthcare providers as well as parents and other relatives.

But CGMs typically still require twice-daily calibration via the traditional finger-stick method. Up next, Dexcom expects to start to untether its CGM from the finger stick--it expects the G6 version will require only one calibration finger stick daily and enable 10-day extended wear. It hopes to start pre-pivotal testing for that newest iteration later this year, with a pivotal study planned for shortly after and a launch planned for early 2017.

Dexcom is trying to encourage G5 adoption among its existing customers by offering a free upgrade to the G5 for those that have ordered the G4 Platinum with Share System since the start of August. In addition, it's offering a "low cost cash upgrade" to the G5 for all patients who remain under warranty for their existing Dexcom CGM system.

 

From FierceMedicalDevices

First and Only Fully Mobile CGM System Allows Adults and Children as young as 2 years old to Conveniently and Discreetly Monitor and Share Glucose Levels

SAN DIEGO--(BUSINESS WIRE)-- Dexcom, a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers." These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.

"Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple WatchTM and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before," stated Kevin Sayer, President and Chief Executive Officer of Dexcom. "We are excited for the promise this new technology holds for patients and caregivers."

About the Dexcom U.S. G5 Mobile Launch
The G5 Mobile system is anticipated to begin shipping in late September 2015.
All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.
There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.
"Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3-2015 earnings call in early November," remarked Sayer.

Enhanced Mobility and Flexibility
Available by prescription, the Dexcom G5 Mobile CGM System features the most accurate glucose sensor on the market while providing enhanced mobility and flexibility to view and share personal glucose data and trends. The only CGM with single digit MARD (Mean Absolute Relative Difference), the Dexcom G5 Mobile comes with the longest-wear sensor on the market and features customizable alerts and a built-in low glucose alarm (55 mg/dL alarm) to warn patients of highs and lows and how quickly they may be happening through a simplified mobile interface. Data from the Dexcom G5 Mobile can be integrated with Dexcom CLARITYTM, a Cloud-based reporting software, for personalized, easy-to-understand analysis of trends that may improve diabetes management.

Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years.The traditional standard-of-care for glucose (blood sugar) monitoring has been a finger stick meter. CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and for guidance in making therapy and meal decisions. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high.

From http://www.fiercemedicaldevices.com/

From Nyhetsinfo

www red DiabetologNytt

Se tidigare inlägg på www.dagensdiabetes.se kring insulinpump 640G

Enligt företrädare för Medtronic idag har företaget begärt prövning hos Kammarrätten av beskedet om att inhibition av Läkemedelsverkets (LVs) beslut ej beviljats av Förvaltningsrätten. Kammarrätten har beviljat prövningstillstånd kring inhibition av beslutet i väntan på utslag i ärendet. Senast om en vecka ska företaget inge yttrande till Kammarrätten. LV har redan inkommit med sitt yttrande. Därefter väntas beslut från Kammarrätten inom förhoppningsvis relativt kort tid. 

Utredare vid Medicinsk Teknik på LM anger idag att myndigheten i nuläget vill avvakta Kammarrättens beslut och avböjer press release eller att gå ut med info på sin www sida. Detta uppges vara de rutiner som LV normalt liksom nu har. 

I dagsläget kan nya Medtronics Minimed 640 G i Sverige för närvarande ej levereras.

De flesta diabetesmottagningar har i brist på annan information beslutat, att pumpen kan användas men att bolusguiden stängs av. Alla patient-användare är i flertalet fall redan kontaktade via telefon eller vid extra besök för information hur man stänger av bolusguiden i pumpen.  Information om orsaken ges med uppgift om problem i time-out funktion i display. Åtgärden om information journalförs.

Så här gör man. 1) Gå in i menyn, 2) välj insulininställning 3) välj bolus wizard stäng av och röd markering visas 4) Nu går det inte att räkna kolhydrater eller få förslag på korrigeringsdos. Denna uträkning får nu göras manuellt 

Nyhetsinfo

www red DiabetologNytt

 

» Den snabbt växande mängden medicinsk programvara och digital utrustning inom både forskningsinriktad och rutinmässig vård har blivit en veritabel utmaning för Läkemedelsverket och resten av världens läkemedelsmyndigheter.
– Vi ser en fullständig explosion av hälso- och vårdrelaterade appar som finns tillgängliga för allmänheten att ladda ned från till exempel Google Play och Appstore.Utmaningen för oss på Läkemedelsverket är att försöka bidra till att de nya tjänsterna och produkterna inom digital hälsa är så säkra som möjligt att använda, säger Mats Artursson, utredare och inspektör på Läkemedelsverket, till Läkemedelsmarknaden.


Läkemedelsverket deltar i nätverket International Medical Device Regulatos Forum, IMDRF, som försöker harmonisera de nationella regelverken för medicinteknik.
– Myndigheter, läkemedelsbolagen och medtechbolagen verkar på en alltmer globaliserad hälso- och sjukvårdsmarknaden. Därför har vi allt att vinna på att harmoniserade regelverk för tillsyn gäller över hela världen, säger Mats Artursson.


För några år sedan blev det alltmer uppenbart att de befintliga regelverken släpade efter den tekniska utvecklingen med till exempel växande användning av mobilt internet. IMDRF har därför sedan 2013 varit inriktad på att ta fram globala riktlinjer för hur industrin och myndigheterna ska definiera medicinsk programvara.
Utvecklingen inom framför allt mobilt internet går snabbt.
– Jag närmast dränks av frågor från tillverkare av appar, som undrar om deras produkt ska betraktas som medicinteknik och därför behöver CE-märkning eller någon form av tillstånd. Bara för tre fyra år sedan fick vi ytterst sällan den typen av förfrågningar, säger Mats Artursson.


I dag finns cirka 100 000 appar som tillverkarna anser vara avsedda för hälso- och sjukvårdsområdet. Appar, annan program- och hårdvara tas fram i rask takt för att möta det växande behovet av kostnadsbesparande automatisering av vård och hemsjukvård, för tidig upptäckt av sjukdomar och för monitorering av till exempel läkemedelsbehandling.
 

En viktig uppgift för Läkemedelsverket och de övriga i IMDRF är att öka utvecklares och tillverkares medvetenhet om de särskilda säkerhets- och valideringskrav som ställs på applikationer och hårdvara inom hälso- och sjukvården.
– Det blir inte juste konkurrens på marknaden om vissa smiter undan sitt säkerhetsansvar. Det vill vi förhindra genom att anpassa regelverken, informera och genom att bedriva ”signalspaning” för att hitta lösningar som inte håller måttet. Sedan kan vi behöva statuera exempel, säger Mats Artursson.


Den tyska läkemedelsmyndigheten statuerade ett exempel genom att återkalla en app som användes för administrering av diabetesbehandling. Appens bristande funktion innebar att den kunde uppmana användaren att ta en felaktig dos insulin. 

VÄRLDENS LÄKEMEDELSMYNDIGHETER SKA NU DEFINIERA MEDICINSKA APPAR

Under hösten ska det globala nätverket International Medical Device Regulatos Forum, IMDRF, presentera en samling dokument som ska öka patientsäkerheten vid användningen av den snabbt växande floran av appar och andra digitala tjänster och produkter inom hälso- och sjukvården.
Under sommaren har Läkemedelsverket varit värd i Uppsala för ett möte där representanter för IMDRF arbetade med dokumentet.
– Vi som arbetar inom världens läkemedelsmyndigheter beskriver i dokumentet hur medicinsk programvara kan defineras, hur vi vill att tillverkarna ska resonera när de beskriver programvarans avsedda användningen och utifrån det kan göra en riskklassificering, säger säger Mats Artursson, utredare och inspektör på Läkemedelsverket, till Läkemedelsmarknaden.


Riskklassificeringen baseras bland annat på om programvaran är avsedd för användning i hemmet eller på en utsatt plats som en akutmottagning.
Mats Artursson betonar att IMDRF har en grundläggande positiv inställning till den snabba utveckling som digitalisering och programvaruutveckling driver fram inom både den forskningsinriktade och den mer rutinmässiga hälso- och sjukvården.


– Men in på området digital hälsa kommer nu helt nya aktörer som inte har kunskap och erfarenhet av de höga krav som ställs på säkerhet och tillförlitlighet inom läkemedel, medtech och hälso- och sjukvården. De är ofta mycket kompetenta i sin verksamhet, men måste lära sig mer om framför allt riskhantering, säger Mats Artursson.
Bland de nya aktörerna finns till exempel spelutvecklare, som nu alltså börjar konkurrera med de traditionella utvecklarna och tillverkarna av till exempel inbyggda IT-system i hälso- och sjukvården. 

Från www. Den här e-postadressen skyddas mot spambots. Du måste tillåta JavaScript för att se den.

Nyhetsinfo

www red DiabetologNytt

Läkemedelsverket, LV, kan hålla fast vid sitt krav på företaget Medtronic från den 31 juli att återkalla samtliga insulinpumpar av modellen MiniMed 640G. Förvaltningsrätten i Uppsala avslog i fredags Medtronics begäran om att LV:s beslut skulle frysas tills domstolen fattat ett beslut i frågan. 

 

Produkten har belagts med marknadsförbud på grund av ett programvarufel i den så kallade Bolusguiden. 

Programvarufelet i MiniMed 640G innebär att patienten riskerar att ge sig själv en felaktig dos insulin (bolusdos), vilket kan resultera i att blodsockervärdet ändras till en så låg eller hög nivå att patientens hälsotillstånd allvarligt försämras.

Medtronics analyser visar att risken att skada ska uppstå är mindre än en på miljonen. 

 

LV skriver följande yttrande i ett följebrev till förvaltningsrätten:

MiniMed 640G insulinpump introducerades av Medtronic i Sverige under 2015. Enligt FSCA-rapporten FA 640 (field safety corrective action) har Medtronic upptäckt två risker:

 

1. Då pumpens Bolusguide kalkylerar värden överskridande pumpens programmerade maximala bolusstorlek tas föråldrade data inte bort i pumpens informationsfönster (popup notification window – no time out).

2. Föråldrad varningsinformation för högt/lågt blodsocker tas inte bort i pumpens informationsfönster (alert notification window – no time out).

 

En grupp läkare skriver i ett yttrande från Medtronic till Läkemedelsverket att de anser att myndighetens beslut saknar medicinsk förankring. De skriver bland annat:

 

”Sammanfattningsvis anser vi att risken för patienten med felaktiga insulindoser och följder av dessa med nuvarande skärmfunktion är lägre än risken med att återkalla denna pump med denna pump med de funktioner som bara finns i MiniMed 640G med tanke på en klart ökad hypoglykemirisk.”

 

Från www.lakemedelsvarlden.se

 

Nyhetsinfo

www red DiabetologNytt

 

(Reuters Health) - A large new review of existing research suggests that for healthy people, a reasonable amount of saturated fat in the diet poses no health risk.

 

Trans fats, on the other hand, were associated with an increased risk of death from any cause, death from cardiovascular disease and a diagnosis of coronary heart disease.

 

Dietary guidelines recommend that saturated fats, found in animal products like butter, egg yolks and salmon, make up no more than 10 percent of daily calories.

Trans unsaturated fats, known as trans fats, like the hydrogenated oils that keep processed foods and margarine shelf-stable, are primarily industrially produced and should provide no more than one percent of daily calories.

 

For the new review, researchers at several Canadian institutions including McMaster University in Hamilton, Ontario, included data from 41 studies of the association between saturated fat intake and health outcomes, covering more than 300,000 people, and 20 studies of trans fat intake and health outcomes that covered more than 200,000.

 

Saturated fat intake was not tied to coronary heart disease, cardiovascular disease, stroke or type 2 diabetes, but its link to risk of death from coronary heart disease was unclear.

 

Consuming industrial trans fats was associated with a 34 percent increase in all-cause mortality, a 28 percent increased risk of heart disease mortality and a 21 percent increase in the risk of heart disease, the study team reports in The BMJ.

 

Because the evidence was uncertain for saturated fats, more studies would be helpful, the researchers write. None of the studies they included were randomized controlled trials, the most rigorous type of study; all were based on observation over time, so other factors in participants’ lives could have played a role in their health outcomes.

 

Several reports since 2010 have confirmed that saturated fats are not associated with heart attack or stroke, said Dr. Ronald M. Krauss of Children’s Hospital Oakland Research Institute in California, a coronary artery disease expert who was not part of the new review.

 

Saturated fats are found in dairy, red meat and tropical oils, he said. “Among these, the only category consistently associated with heart disease risk is red meat, and even in this case, it's not clear that saturated fat all by itself is the main culprit,” Krauss told Reuters Health by email. “There may be other potential mechanisms.”

 

Unlike saturated fats, trans fats lower "good cholesterol,” he said.

 

Among men, trans fatty acid intake declined between 1980 and 2009 from 2.9 percent of daily calories to 1.9 percent, according to a 2014 study (see Reuters Health story of October 22, 2014 here: reut.rs/1z0fHu4).

 

“We have known that trans fats are bad for us, and the evidence for that has been strong enough that these fats are now being removed from the food supply,” said Patty W. Siri-Tarino, also of Children's Hospital Oakland Research Institute.

 

The U.S. Food and Drug Administration has given food manufacturers until 2018 to remove trans fats from the food supply, she told Reuters Health by email.

 

There is now enough evidence to shift focus from the amount of saturated fat in the diet to intake of specific food categories, Krauss said.

 

Individual saturated fats vary widely in their food sources as well as their potential health effect, said Dr. Rajiv Chowdhury, senior cardiovascular scientist at the University of Cambridge in the U.K.

 

Some are harmful while others may actually be beneficial, so their total amount in the diet seems to have no association with health outcomes like death, he told Reuters Health by email.

 

More research on saturated fats is needed, and trans fats should be totally avoided in the diet, Chowdhury said.

 

“This study shows that focusing on reducing saturated fats as the primary goal in eating well is not quite right,” Siri-Tarino said.

 

“Eating well means replacing those saturated fats with polyunsaturated fats rather than carbohydrates, particularly refined and processed carbohydrates, which is what usually happens,” she added.

 

“There are still people who will benefit from controlling the amount of saturated fat they consume, but it's not the most important part of the diet to be concerned about,” she said.

 

SOURCE: bit.ly/1sk4kGq The BMJ, online August 11, 2015.

Nyhetsinfo

ww red DiabetologNytt

Kontinuerliga blodsockermätare delas ut lovar sjukvårdsledningen efter uppmärksammade Barndiabeteskampen

Sjukvårdens ansvariga i länet håller med Barndiabeteskampen.

– Min grundinställning är att alla barnfamiljer i Dalarna som vill och sedan använder en kontinuerlig blodsockermätare ska få en, säger Anna Olivecrona - chef för barn- och ungdomssjukvården i länet.

Under gårdagen berättade DT om kampanjen Barndiabeteskampen som kräver att alla som drabbats av typ 1 diabetes ska få en så kallad automatisk kontinuerlig blodsockermätare med fjärravläsning. Det skulle leda till en avsevärd minskad risk för följdsjukdomar, som hjärt- och kärlsjukdomar, stroke, synskador och minskad blodcirkulation som leder till amputation. Vilket i sin tur skulle ge samhällsekonomiska vinster när sjukvården slipper kostsamma efterbehandlingar.

– Jag är böjd att hålla med. Om blodsockernivåerna blir bättre så minskar ju riskerna för följdsjukdomar. Mätaren innebär också en avsevärd ökad livskvalitet för de drabbade barnen, säger Olivecrona.

Vid årsskiftet kom nya nationella kriterier från barnläkarföreningen.

Vi har tagit beslut om att följa dessa. Det handlar ju bland annat om att alla under sju år, barn som behöver ta mycket frekventa blodsocker, barn med neuropsykiatriska handikapp, ungdomar i pubertet och barn- och ungdomar som har högt Hba1c (höga genomsnittliga blodsockernivåer över 6-8 veckor, red) får en mätare.

– Min grundinställning är att alla barnfamiljer som vill ha en mätare, och sedan använder den, ska få testa en mätare. Vi ska däremot inte med automatik dela ut mätare, som sedan ligger oanvända i en byrålåda. De mätare vi har nu kostar ändå 30 000 per år, säger hon.

Länssjukvårdens högst ansvariga Anna Olivecrona brinner för saken. Tidigare var hon diabetesvårdens chef i länet. Hon är också nationell ordförande för barnläkarföreningens delförening för diabetes.

– Jag arbetar för att barn- och ungdomar med diabetes ska få bra vård. Därför känns debatten - att sjukvården i Dalarna skulle missgynna diabetesdrabbade - konstig. Jag är helt för att vi ska erbjuda den bästa möjliga vården och utrustningen. I grunden vill jag att alla barn- och ungdomar med diabetes ska kunna erbjudas en mätare, säger hon.

Att Dalarna skulle ha den sämsta välviljan i landet håller hon inte med om.

– Dalarna ligger ungefär på ett medelvärde i landet i hur stor andel som har en mätare. Det är dock stora variationer i landet idag, säger hon.

Ledningen har sett över situationen. Det har visat sig att diabetesteamet inte följt de nya rekommendationerna.

– Ett flertal barn- och ungdomar som enligt rekommendationen borde ha fått erbjudande om en kontinuerlig mätare har inte har fått det. Jag beklagar detta och kommer att se till att det åtgärdas omgående, säger hon.

I dag har 44 barn i länet en mätare. Många fler, totalt 160 barn, har diabetes typ 1.

–Vi ska vara frikostiga med bra hjälpmedel. Men alla kommer inte få en kontinuerlig blodsockermätare. Alla vill inte. Jag vill inte heller att vi delar ut mätare som inte används, säger hon.

Hon beklagar att flera familjer känt sig tvingade att köpa egna mätare.

– Så ska det inte vara. Detta ska inte riskera bli en klassfråga. Alla som vill och sedan använder mätaren aktivt ska få prova en mätare, säger hon.

Anna Olivecrona betonar att pengar och budgetkrav inte styrt situationen i Dalarna.

– Vi har inga sparbeting på diabetesvården, förutom att rekreationsverksamheten i Tandådalen avvecklas. Det finns inga bakomliggande beslut om att vara restriktiv. Tvärtom. Landstingsdirektör Karin Stikå Mjöberg och landstingsråd Ingalill Persson är helt överens med mig om hur vi ska arbeta i den här frågan. Vi vill att barndiabetesvården i Dalarna ska hålla toppklass, säger Anna Olivecrona.

Från tidningen Dalademokraten www idag

http://www.dt.se/allmant/dalarna/blodsockermatare-delas-ut-lovar-sjukvardsledningen-efter-uppmarksammade-barndiabeteskampen

Läs också:

Barndiabeteskampen välkomnar landstingets besked

Nyhetsinfo

www red DiabetologNytt

The American Diabetes Association (ADA) and the American Heart Association (AHA) have issued a newly revised joint scientific statement on prevention of cardiovascular disease in adults with type 2 diabetes.

The statement, which updates the previous one from 2007 (which updated the original one from 1999), was published jointly online August 5 in both Diabetes Care and Circulation by a writing group cochaired by Caroline S Fox, MD, a senior investigator at the National Heart, Lung, and Blood Institute, Bethesda, Maryland, and Sherita Hill Golden, MD, executive vice chair of the department of medicine and professor of medicine at Johns Hopkins University, Baltimore, Maryland.

"Cardiovascular disease is the leading cause of death in people with diabetes, so in terms of morbidity and mortality, risk management is critically important….We feel that this is a one-stop resource to get the newest information in cardiovascular disease prevention," Dr Golden told Medscape Medical News.

The document summarizes information from studies published since 2008, as well as changes in guidelines from the respective organizations based on those data. "We tried to be congruent. This is a joint statement from the ADA and AHA. Many members of the writing group are active in both organizations. The idea was for us to be unified in our recommendations," she said.

Included are diagnostic criteria — including the ADA's 2010 recommendation for use of HbA1c to diagnose diabetes, lifestyle management including physical activity and nutrition, weight management, aspirin use, glucose control, blood-pressure management, lipid management, screening for renal and CVD complications, and a list of controversial areas requiring further research.

Major Changes in ABC of Diabetes Care in Past 8 Years

Dr Golden said that since 2007, major changes have occurred in each of the "ABC" elements of diabetes care. Back in 2007, people were still questioning whether further reducing the upper target of HbA1c (the "A") as 7% would provide further cardiovascular disease benefit.

That was shown not to be the case by three major trials reported in 2008, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study , the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) trial , and the Veterans Affairs Diabetes Trial (VADT).

"So, that 7% is still a target, but when you're focusing on preventing CVD glucose isn't the main target," Dr Golden said.

Guidelines for blood pressure ("B") in people with diabetes have also recently been loosened from 130/80 mm Hg to 140/90 mm Hg, based on data such as those of the 2010 ACCORD blood pressure trial showing that the goal of 130/80 did not provide further benefit and was associated with more side effects.

"We feel comfortable that our current target is appropriate for CVD prevention," she said.

And for cholesterol, the "C," a major shift came in 2013, with the AHA/American College of Cardiology advising clinicians to stop treating to LDL target but instead base the use of statins on overall CVD risk.

 

The guideline, which places most people with type 2 diabetes on moderate or high-dose statins, was generally endorsed by ADA.

The section on lifestyle modification notes that the Look AHEAD trial, published in 2013, showed that although intensive lifestyle intervention didn't reduce CVD, it did improve functioning and quality of life and reduced the number of medications that diabetes patients need to take.

Six Areas for Further Research

The ADA/AHA document also lists six main areas in need of further research:

  • The role of glucose-lowering drugs in reducing cardiovascular events.

  • The role of bariatric surgery.

  • The risks of hypoglycemia on the cardiovascular system.

  • The appropriate targets for blood pressure lowering.

  • The role of triglyceride lowering.

  • Imaging for subclinical CVD assessment.

Dr Golden and Dr Fox have no relevant financial relationships. Disclosures for the coauthors are listed in the article.

Diabetes Care. Published online August 5, 2015. Abstract

Circulation. Published online August 5, 2015. Abstract

From http://www.medscape.com

ABSTRACT

Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence: A Scientific Statement From the American Heart Association and the American Diabetes Association

  1. Dorothea K. Vafiadis on behalf of the American Heart Association Diabetes Committee of the Council on Lifestyle and Cardiometabolic Health, Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, Council on Quality of Care and Outcomes Research, and the American Diabetes Association
  1. Corresponding author: Caroline S. Fox, Den här e-postadressen skyddas mot spambots. Du måste tillåta JavaScript för att se den..

Abstract

Cardiovascular disease risk factor control as primary prevention in patients with type 2 diabetes mellitus has changed substantially in the past few years. The purpose of this scientific statement is to review the current literature and key clinical trials pertaining to blood pressure and blood glucose control, cholesterol management, aspirin therapy, and lifestyle modification. We present a synthesis of the recent literature, new guidelines, and clinical targets, including screening for kidney and subclinical cardiovascular disease for the contemporary management of patients with type 2 diabetes mellitus.

Nyhetsinfo

www red DiabetologNytt                 

FacebookTwitterLinkedinGoogle Bookmarks