Category: NICE

NICE recommends UrgoStart dressings

kaitiscotland2 Comments

From BMJ 9 Feb 19

NICE have recommended that a new dressing, UrgoStart, may be used to treat non infective diabetic and vascular ulcers.

The dressing contains material that inhibits enzymes from the tissues that inhibit wound healing. They estimated that these dressings can speed up healing and save the NHS £342 per patient per year. This takes into account the savings on dressings, nurse, GP and out patient visits.

They estimated that if a quarter of all diabetic ulcer patients were changed to this dressing that the NHS could save £5.4 million a year.

My comment: We are not using it in our surgery yet.

 

What’s new in the prevention of the microvascular complications of diabetes?

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Apart from blood sugar control what’s new in the prevention of the microvascular complications of diabetes?

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Retinopathy

At diagnosis, 10.5% of type two diabetics already have retinopathy. New research has shown that severe proliferative diabetic neuropathy can be predicted by measuring the size of retinal blood vessels, but this is still being developed in research centres. It could become a part of the usual screening process in the future.

Lowering blood pressure in those who are hypertensive by at least 10 points, can reduce the onset of retinopathy but does not affect the rate at which it develops into proliferative retinopathy. What does seem to work is the use of oral Fenofibrate.

Laser photocoagulation reduces the rate of progression of proliferative retinopathy and the onset of severe visual loss. Direct injection of drugs that inhibit Vascular Endothelial Growth Factor such as pegaptanib, ranibizumab, and bevacizumab also help but they are less freely available, due to cost.

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Nephropathy

NICE recommend spot urinary albumin to the creatinine ratio and glomerular filtration rate on diagnosis and then yearly. If the rate is raised on 2 out of 3 samples within six months then nephropathy is confirmed and the severity graded.

Blood pressure targets are 140/90 for those without nephropathy and 130/80 for those that have it. Some people may benefit from lower blood pressure targets of 120 systolic such as Asian, Hispanic and African American populations.

Both ACE inhibitors and Sartans (ARB) reduce nephropathy and ACE inhibitors also improve all- cause mortality.  These drugs are the first choice for most diabetics when prescribing anti-hypertensives.

Early referral to a nephrologist showed an improvement in interventions and mortality rates. There was also a small improvement in kidney function when the new drug Dapagliflozin was used.

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Neuropathy

There are other causes of neuropathy that may need to be considered before diabetic neuropathy is diagnosed. These are: alcohol, chemotherapy, vitamin B12 deficiency, hypothyroidism, renal disease, paraneoplastic syndromes due to eg multiple myeloma and bronchogenic carcinoma, HIV infection, chronic inflammatory demyelinating neuropathy, inherited neuropathies and vasculitis.

A new Japanese drug Epalrestat improved diabetic neuropathy but did not improve autonomic neuropathy.

There was insufficient evidence to show that exercise, pulse infrared light therapy, education about foot ulceration and complex interventions such as combining patient education, podiatry care, foot ulceration assessment, motivational coaching to provide self- care, worked or not.

 

BMJ 4th February 2017 Willy Marcos Valencia and Hermez Florez from Miami Florida.

 BMJ 2017;356:i6505

What’s new for type one diabetics?

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NICE have released their new guidelines for type one adults. This paper was given some prominence in September’s BMJ as well as other papers that could be of interest to diabetics, their carers and health professionals.

In many respects the adult guidelines are similar to the children’s guidelines. Structured education gets support as does advice to aim for a hba1c of 6.5% (48) or lower provided hypos can be minimised. Of course this is virtually impossible if a high carb diet is followed but is much easier if the low carb dietary advice and precision meal to insulin matching as we describe in our book is done.

Levemir twice a day is the recommended basal insulin for all new patients and Lantus is advised only for those who refuse to use a twice daily bolus or perhaps need assistance from others for injection. We know that Lantus has some gaps in coverage as a 24 hour insulin and that it is less stable in heat and light than Levemir. It also stings on injection. Levemir also gives fewer hypos. Of course if someone is happy with Lantus, they can stay on it.

Life expectancy for type ones is currently 13 years less than for people without the condition. Fewer than 30% of adults achieve a hba1c of 7.5% or less.

Although the Cochrane collaboration noted a small degree of success with a low glycaemic diet strategy for type twos, this was not seen in the research that NICE looked at for type ones and therefore they don’t recommend low glycaemic as a dietary strategy.

Blood sugar targets are suggested to be ideally 5-7 first thing in the morning, 4-7 before meals and 5-9 at least 90 minutes after meals. Adults are advised that 4-10 blood sugar tests may be required each day. Before each meal and before bedtime are minimum testing times.

NICE want type ones to stick to their finger tips for blood sugar testing. This is the most accurate as hypos can be missed if other parts of the upper limb are used.

It is recommended that hypos are evaluated at least annually by a scoring system. The idea is to seek out those people for whom these are a problem and then fix it. NICE say this should not involve simply raising blood sugar targets. The obvious thing is to match insulin to meals, activity and basal needs more closely. If structured education around this appears to fail then the person should be considered for pump therapy and real time glucose monitoring.

Meal insulin boluses are recommended before meals. After meals is a strategy that works for toddlers but adults are expected to be able to adjust their insulin to meals and that means that they must be able to carb count.

So what can we expect from the implementation of these guidelines? There is still no clarity over diet and exactly how patients will get near normal blood sugars just by carb counting without actually restricting the amount they consume isn’t explained. There certainly will be a lot more adults who could be considered for pumps. But these are relatively expensive and require a lot of training. Setting strict blood sugar targets and hoping that technology will solve the problem has been going on for decades now. Why should it work now? NICE admits it hasn’t worked so far with more than 70% of type one adults having wildly high blood sugars. I would have been very interested to know what percentage of adults with diabetes achieved the target blood sugars of 6.5% or 48.

NICE do admit that to implement their proposals the medical workforce will need to be sufficiently trained to deliver the structured education and to help individual diabetics with their problems.

Bariatric surgery better than diets for sustained weight loss

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Bariatric surgery has been shown to be the most effective treatment for substantial and sustained weight loss with a significant reduction in obesity related conditions and long term mortality according to the National Confidential Enquiry into Patient Outcome and Death 2014. Bariatric surgery operations are likely to become more popular as a result.

Bariatric surgery is particularly helpful for diabetics because it can greatly improve blood sugar control and even induce complete remission of type two diabetes. NICE recommends that those with a body mass index over 30 who have had diabetes for under ten years are considered for the operation. Asians may be considered at even lower BMIs.  Simple observation will demonstrate that there are many more people eligible for these operations than can currently be dealt with on the NHS. Indeed currently just under a third of patients pay for the operations themselves.

There are various types of surgery. Some reduce the area of the stomach like the laparoscopic adjustable band,  and some reduce absorption of nutrients like the sleeve gastrectomy. Some are a mixture of the two like the Roux-en-Y gastric band which is the commonest procedure that also produces the greatest weight loss.

Excess weight loss can be as high as 58% with patients’ weight levelling off after two years. Weight gain can recur and this can be due to not following the diet or a surgical failure than needs adjustment.

Once referred to a bariatric clinic the advantages and disadvantages of the various types of surgery is discussed. Psychological support and dietetic support is given. I recall that a bariatric surgeon told me that people referred to his clinic had very marked self- esteem issues and often defaulted from the clinic.

The short term problems after surgery include wound infections, vomiting, intolerance to pureed meals, problems swallowing and leaks at the staple lines for some operations.

Long term patients will need to continue to restrict calories and take multivitamins.  Acid suppression therapy is often required and patients should avoid non- steroidal anti-inflammatories. Gall stones may occur and may require surgical removal.  Hair loss may occur but is temporary.

After a Roux-en-Y operation calories are restricted to less than a thousand a day.  Patients have to take a protein rich diet so they do not become deficient. Iron supplement are particularly needed by women. Most people require vitamin B12 injections every 3 to 6 months. B vitamins, calcium and vitamin D, and the fat soluble vitamins A, D, E and K may be needed.  Annual checks of full blood count, electrolytes, liver function, glucose, iron, ferritin, vitamin D, B 12, calcium, parathyroid hormone, thiamine, folate and selenium are required.

The good news for diabetic  is that blood sugars often improve a great deal and for many  return to normal. Thus insulin and drug requirements will lessen or even stop.  Blood pressure, lipid problems and obstructive sleep- apnea also improve or resolve.

Women may find that they are able to conceive after bariatric surgery but this is discouraged for about 18 months after surgery because of the rapid weight loss and nutritional deficiencies that are common at this time. There is more risk of pre-term and small for age births in women post- surgery.

It can be seen that should the number of surgeries be increased to anything like what is required to deal with the obesity/diabetes epidemic, that resources for long term follow up of these patients will also need to be improved. Support for General Practitioners  will be needed, particularly as there is not sufficient structured follow up, particularly for those who have had operations out with the NHS and even abroad.

Based on article by Vamshi P Jagadesham and Marion Sloan from Sheffield in British Journal of General Practice August 2014.

What can diabetic women expect when they are expecting?

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NICE have come up with some sensible improvements for the management of diabetic pregnancies that should reduce complications for mothers and babies in the future. None of these changes are radical and indeed they are already considered best practice, but what is different is that they want to see if best practice can be made routine.

Frequency

Approximately 700,000 women give birth in England and Wales each year, and up to 5% of these women have either pre‑existing diabetes or gestational diabetes. Of women who have diabetes during pregnancy, it is estimated that approximately 87.5% have gestational diabetes (which may or may not resolve after pregnancy), 7.5% have type 1 diabetes and the remaining 5% have type 2 diabetes. The prevalence of all 3 types of diabetes is increasing. The incidence of gestational diabetes is also increasing as a result of higher rates of obesity in the general population and more pregnancies in older women.

Risks

Diabetes in pregnancy is associated with risks to the woman and to the developing fetus. Miscarriage, pre‑eclampsia and preterm labour are more common in women with pre‑existing diabetes. In addition, diabetic retinopathy can worsen rapidly during pregnancy. Stillbirth, congenital malformations, macrosomia, birth injury, perinatal mortality and postnatal adaptation problems (such as hypoglycaemia) are more common in babies born to women with pre-existing diabetes. For women diagnosed with gestational diabetes, hyperglycaemia usually resolves after pregnancy, but a proportion of these women will have type 2 diabetes after the birth. Therefore, before a woman is discharged to the care of her GP, her blood glucose levels should be tested to ensure that they have returned to normal.  Women with pre-existing diabetes will be managed in general adult diabetes services after the birth.

List of recommendations

  1. Women with diabetes planning a pregnancy are prescribed 5mg/day folic acid until 12 weeks gestation.

High-dose folic acid supplements should be prescribed for women with diabetes from at least 3 months before conception until 12 weeks of gestation, because they are at greater risk of having a baby with a neural tube defect. The benefits of high-dose folic acid supplementation should be discussed with the woman during preconception counselling as part of her preparation for pregnancy. If a woman with diabetes has an unplanned pregnancy, she should be prescribed high-dose folic acid as soon as the pregnancy is confirmed.

  1. Pregnant women with diabetes are supported to self-monitor their blood glucose levels during pregnancy.

Women with diabetes need to be able to self-monitor their blood glucose levels at an increased frequency during pregnancy. This will help them to maintain good blood glucose control throughout pregnancy, which in turn will reduce the risk of adverse outcomes such as fetal macrosomia, trauma during birth, induction of labour and/or caesarean section, neonatal hypoglycaemia and perinatal death. Support should be provided to ensure that women have access to blood glucose monitors and enough testing strips, and know how to use them.

  1. Women with pre-existing diabetes are seen at the joint diabetes and antenatal care clinic within 1 week of their pregnancy being confirmed.

Women with diabetes who become pregnant need additional care in addition to routine antenatal care. A joint diabetes and antenatal clinic is able to ensure that specialist care is delivered in order to minimise adverse pregnancy outcomes. Immediate access to a joint diabetes and antenatal clinic within 1 week will help to ensure that a woman’s diabetes is controlled during early pregnancy, when there in an increased risk of fetal loss and anomalies. It will also help to ensure that the woman’s care is planned appropriately throughout her pregnancy.

  1. Pregnant women with pre-existing diabetes have their HbA1c levels measured at their booking appointment.

A woman’s HbA1c levels can be used to determine the level of risk for her pregnancy. Women who had diabetes before they became pregnant should have their HbA1c levels measured during early pregnancy to identify the risk of potential adverse pregnancy outcomes and to ensure that any identified risks are managed.

  1. Pregnant women with pre-existing diabetes are referred for retinal assessment at their booking appointment.

Pregnant women with diabetes can have an increased risk of progression of diabetic retinopathy. Pregnant women should therefore be screened more often for diabetic retinopathy. Retinal assessment should be offered at the booking appointment unless the woman has had an assessment in the last 3 months.

  1. Pregnant women diagnosed with gestational diabetes are reviewed at the joint diabetes and antenatal care clinic within 1 week of diagnosis.

Pregnant women diagnosed with gestational diabetes should have specialist advice and treatment in a timely manner, and should be reviewed by members of the joint diabetes and antenatal care team within 1 week of being diagnosed. The joint clinic should provide the woman with advice, including why gestational diabetes occurs, potential risks and complications, and treatments aimed at reducing those risks.

  1. Women who have had gestational diabetes have annual HbA1c testing

Women who have had gestational diabetes are at increased risk of getting it again in future pregnancies. They are also at higher risk of type 2 diabetes: if they are not diagnosed with type 2 diabetes in the immediate postnatal period (up to 13 weeks after the birth), they are still at high risk of developing it in the future. Early detection of type 2 diabetes by annual HbA1c testing in primary care can delay disease progression and reduce the risk of complications. Annual testing can also reduce the risk of uncontrolled or undetected diabetes in future pregnancies.

Readers of our book can find information of the blood sugar targets that are optimal in pre-pregnancy and pregnancy and of course the type of food and menus that will help them achieve these targets. Detailed insulin administration tips are also described to optimise insulin to meal matching.