How does blood sugar control compare between pump users and insulin injecting adults?

insulin pump

If adults get the same level of education about blood sugar management there is only a tiny improvement in blood sugar control with a pump compared to a basal bolus injection regime.

The REPOSE trial was based in the UK with 315 participants across eight sites. Using small groups the patients were taught the DAFNE course, Dose Adjustment for Normal Eating. After the course the patients were randomised to either multiple daily injections which is standard UK management, or insulin pump use.

The organisers wanted to see how many people managed to get their hba1c below 7.5% after two years and what effects the regimes had on quality of life and hypoglycaemia.

Out of the original 315 patients, 260 finished the courses and entered the trial. There were small improvements in both groups for hba1c. The pump group got a 0.85% improvement in hba1c and the injectors got 0.42% improvement. This was not considered to be good enough to recommend pump provision, which is more expensive than pen injectors, to adults as a routine measure.

The pump group started with hba1s averaging around 9.5% and ended up around 8.7%. The injectors started with an average of 9.0% and ended up around 8.5%.  In addition there was no particular difference in hypoglycaemia or psychosocial outcomes.

My comment: It is a pity that DAFNE is considered the gold standard educational tool for type one diabetics when the outcomes are so underwhelming. The main problems are that although carb counting is included, carbohydrate restriction is not.  Insulin coverage of protein is not done and the seven unit rule is ignored. These are the main reasons that the outcomes are so poor. Structured education in person is expensive and time consuming for health care professionals. Why not grasp the nettle and actually teach people what they need to know to get normal blood sugars and not hba1cs of 8.5-8.7 which are certain to lead to diabetic complications?

Based on BMJ article BMJ 2017;356:j1285

Anal injuries in Childbirth: A new charity for this rarely discussed problem

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Adapted from Anne Gulland’s interview with surgeon Michael Keighley published in BMJ  25 March 2017.

About one in ten first time mothers who give birth vaginally can develop some sort of anal incontinence. This can lead to soiling, passing wind when you’d rather not, and needing a toilet urgently.

Despite the number of women affected it is rarely talked about. Some women feel trapped in their homes and hide dirty sheets from their partners. Returning to work is a difficulty too.

If the matter has not resolved in a few months surgery is usually required. Even then, this tends to be a patch up job, as getting normal anal function back is difficult. A woman may be able to hold stool in for say three or four minutes after surgery compared to one minute before this.  As the years go on however, anal function can deteriorate again, especially after the menopause.

A study is being done by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives to try to get women to hold back in the second stage of labour as the baby’s head is being delivered. Giving a bit more time for the perineum to stretch, rather than just pushing the baby out, can reduce anal tears from 8% to 3%.

If anal tears are detected immediately and repaired by an obstetrician at the time, the success rate is better for the woman. If the tears are left, more scar tissue develops, and this impairs the result of future surgery.

The name of the new charity is: masic.org.uk

 

Mayo Clinic Statin decision aid

Mayo clinic statin decision aid

 

https://statindecisionaid.mayoclinic.org/index.php/statin/

 

The Mayo Clinic have a free online decision aid which will graphically represent the difference in heart attack risk that you face over the next ten years. You can choose three different calculation algorithms. Each varies a bit regarding factors that they consider important. The units section can transfer according to what system your lab uses for cholesterol results. In the UK they use the mmol/mol and in the US it is mg/dl.

Like other decision aids it has no facility to calculate the possible downside to statin use.

I put my measurements in and got a 3% risk on the AHA figures which would drop to a 2% risk on low dose statins. High dose statins would make no difference to this. Using the Framingham criteria my risk came in at 8% dropping to 6% on low dose statins. The Reynolds criteria uses high sensitivity CRP which we don’t measure in the UK. 

 

 

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

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.

dialysis

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

Planning a pregnancy: the importance of getting slim before you get started

newborn baby

In Europe the World Health Organisation estimate that more than 50% of men and women are overweight or obese and 23% of women are obese.

In a pregnant woman obesity raises her chances of gestational diabetes and pre-eclampsia. She is also more likely to get metabolic syndrome and type two diabetes later in life. The resulting children are more likely to come to harm in utero and at birth and also more likely to become fat children. They are then more likely to develop higher blood pressure and excess weight in early adulthood.

Despite the push to improve the outcome for the babies in utero, lifestyle changes and medical interventions have largely proved unsuccessful.

Women with a BMI over 25 find it more difficult to conceive in the first place and then are more likely to miscarry compared to their slimmer sisters. The miscarriage rate is 1.67. Congenital abnormalities become more common.

The placenta responds to maternal insulin levels. In normal weight women they become 40-50% less sensitive to insulin but this bounces back within days of delivery. Obese women show greater decreases in insulin sensitivity, this affects lipid and amino acid metabolism. African Americans and Southern Asians get these changes at lower body masses than Europeans.

Obese women are more likely to go into labour early. They also may need to be delivered early. They have a higher rate of failed trial of labour, caesarean sections and endometritis and have five times the risk of neonatal injury.

Anaesthetic complications are more common. The Royal College of Obstetrics and Gynaecology recommend that women with a BMI over 40 see an obstetric anaesthetist before going into labour. Epidural failure is more common. The woman may have lower blood pressure and respiratory problems and the baby may have more heart rate decelerations in labour.

Broad spectrum antibiotics are recommended for all caesarean sections. Despite this, overweight women get more post- operative infections. The wounds are also more likely to come apart.

Obese pregnant women are obviously at even more risk.

Babies of obese mothers are usually fatter at birth compared to other babies. Obese mums tend to put on more weight than average during the pregnancy and then find it even harder to lose weight after delivery.

Recent randomised controlled trial  have shown that interventions started after pregnancy have little or no effect. These include increasing the mum’s physical activity and cutting the dietary glycaemic load. These things reduced the weight gained in pregnancy a little but did not affect adverse pregnancy outcomes and the birth of fat babies. Thus there is now a bigger push to intervene before pregnancy.  

Currently between ten and twenty percent of obese women lose weight between pregnancies. This has been found to reduce weight gain in the next pregnancy and also the risk of pre-eclampsia.  Supervised intensive lifestyle interventions can be done, work and are safe, even in breast feeding mothers. Pre-pregnancy classes to get women fit for pregnancy would help improve the outcome for the babies of the future.  The metabolic environment, a mixture of inflammation, insulin resistance, lipotoxicity, and hyperinsulinemia,  can then be optimised prior to conception. After this, it is really too late.

 

Adapted from Obesity and Pregnancy. Patrick M Catalano and Kartik Shankar from Cleveland Ohio and Little Rock Arkansas Universities.  BMJ 18 February 2017 BMJ 2017;356;j1

Obesity raises the risk of cancer

cancer

Obesity is strongly associated with eleven different cancers.

These are: oesophageal, multiple myeloma, stomach, colon, rectum, biliary tract, pancreas, breast, endometrium, ovary and kidney.  For many cancers there seems to be a dose response.

This was found by Kyrgiou and colleagues by studying over 95 meta-analyses from various sources.

The BMJ reports, “The unavoidable conclusion is that preventing excess adult weight gain can reduce the risk of cancer. Furthermore, emerging evidence suggests that excess body fat in early life also has an adverse effect on the risk of cancer in adulthood. Clinicians, particularly those in primary care, can be a powerful force to lower the burden of obesity related cancers, as well as the many other chronic diseases linked to obesity such as diabetes, heart disease and stroke. The data are clear. The time for action is now.”

As a GP, I don’t really think that I am a “powerful force” that can turn the obesity epidemic round. It is amazing what faith the authors Yikyung Park and Graham Colditz have regarding our abilities.

 

Adapted from Adiposity and cancer at major anatomical sites BMJ 2017; 356:j477 and BMJ 2017;356:j908

What being frail means

Miss Havisham

Getting older and frailer is something that we are all going to experience unless we die of something else. We are liable to lose weight, particularly muscle mass, tire very easily, have muscle weakness and be unable to perform our usual activities, and we will walk, if at all, much more slowly.

Along with the obvious external signs, our hearts, kidneys, immune system and bones will weaken. We are more likely to become diabetic, get dementia and other neurological disorders, break bones and get cancer. Our senses dull too, with poor vision, hearing and balance problems. Our appetites dull and we will eat less.

In the USA, a quarter of over 65s are considered frail. Other disease processes could be going on as well as simply getting more frail with age.  Poverty, lonliness, poor diet, polypharmacy and cognitive decline make the situation worse.

More than 70% of frail people have two or more chronic diseases. The commonest are hypertension and osteoarthritis. Insulin resistance leads to type two diabetes. The combination makes falls and fractures more likely than people with simple frailty.

Cardiac failure, anaemia, osteoporosis occur. Parkinson’s disease, Alziehmer’s, Vascular Dementia and Depression are several times more common in the frail population. Cancers, infections and a poorer response to vaccination occur.

Drug reactions are more of a problem in this group of people. They have accumulated more diseases and symptoms and thus more drugs, but they also have a lower body mass and poorer kidney and liver function so that drugs accumulate more easily in the system.  Some drugs cause confusion, instability and falls. A study in a geriatric day hospital showed that on average a person was on 15 different medications and that you can expect about nine of these to have the potential for some problem.

Diogenes and Havisham syndrome refers to a situation where an elderly person lives in socially isolated and filthy conditions. They continue to neglect themselves and are resistant to change. This is more common in those suffering from dementia.

Pressure ulcers may occur unless nursing care is of a very high standard.  Elder abuse can sometimes occur when demands on carers exceed what they can provide.

Although a major sign of frailty is weight loss, you can get a condition called sarcopenic obesity. The person still has too much body fat, but the muscle mass is very low. This population is increasing in numbers as the obesity epidemic continues.

The more frail a person is, the less well they come through surgery successfully.

Hypothermia is more likely in frail people, particularly older age groups, women, more chronic disease eg diabetes, social isolation and those who have sustained a hip fracture.

So, not too much to look forward too! I hope this information will help those of you who care for elderly relatives. When we are looking after ourselves, it is important to keep our muscle mass up to reduce sarcopenia and the difficulty mobilising that is a cardinal sign of the problem of normal aging.

 

Adapted from Frailty Syndrome- Medico legal considerations. Roger W. Byard, University of Adelaide, Australia. Printed in Forensic and Legal Medicine. Volume 30 Pages 34-38. Elselvier.

Rowan Hillson:Diabetes and fracture risk

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Adapted from:

 

Fractures and Diabetes

Rowan Hillson MBE

National Clinical Director for Diabetes England 2008-18

 

Practical Diabetes Jan/Feb 17

Summary

Fractures are more likely in diabetics compared to non- diabetics. Metabolic factors, an increased risk of falls, complications, infection, medications and the effects of low blood sugars all contribute. Neuropathy is a particular problem. This can cause an abnormal gait, stumbling, and a lack of awareness of actually sustaining injury. Even fractures may not cause anything like the expected pain. Charcot’s foot can cause lifelong disability. Visual problems also cause falls as does the effects of stroke and amputation.

It can help if someone goes round the house to check for trip hazards. Vitamin D supplements and increasing dietary calcium can help. Be aware that sulphonylureas can cause low blood sugars as well as insulin.

If a diabetic, particularly one who has neuropathy, presents with an injury they need careful evaluation to avoid missing fractures.

Fracture risk

Type one women  are six times more likely and type twos are twice as likely to sustain a fracture of the hip than a non diabetic. The longer the diabetes, the more the risk.

Low blood sugars

Low blood sugars are probably under reported by diabetics due to fears about losing their driving licences.

 

charcot-foot

Charcot Foot

Charcot foot presents as a swollen, red foot. There can be an underlying fracture. Because the person does not realise they have a fracture, they continue to weight bear, and this produces deformity of the foot. Best advice is that if a diabetic with neuropathy gets an unexplained inflammation of a foot that they stay off of it and get an urgent assessment by a multi disciplinary team at a diabetic foot clinic. Trouble is, that these are not available for all patients in the UK.

Drugs

Glitazones, eg Pioglitazone, doubles the risk of upper limb fracture in women.  Flozins such as Canaglifozin is suspected of increasing fracture rates and Sulphonyureas definitely do, but probably due to the hypoglycaemic effect.

Falls

Diabetics fall more than their non-diabetic counterparts. 18% of women over the age of 67 with diabetes fell at least once a year. The rate is higher in insulin users, neuropathy,  renal impairment, poor vision and low Hba1cs.

 

 

Robert Redfern: High carb diet causes memory loss as we age

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As reported in Naturally Healthy News Issue 24

Eating a diet that’s rich in carbohydrates – sweets, soft drinks, bread, pasta and potatoes- is  a direct cause of mild dementia and memory loss as we get older. Starch and sugar cause cognitive impairment.

A diet that is high in fats and protein is far less likely to cause mental decline, say Mayo Clinic researchers. 

They have found that carbohydrates interfere with the body’s ability to metabolise glucose and insulin which are needed to feed the brain.

The carbohydrate link was found when researchers analysed the lifestyles and diets of 937 people aged 70-89 years. They found that those who ate the most carbohydrates were 3.6 times more likely to show mild cognitive decline, including problems with memory, language, thinking and judgement. 

Those who ate fats were 42% less likely to suffer cognitive decline and those who ate high protein diets had 21% less risk.

( Alzheimers Dis, 2012;32:329-39)

 

Dr Claude Lardinois: Albumin’s important role in detecting heart and kidney disease

In part two of Dr Lardinois’ interview for Diabetes in Control we learn more often overlooked points regarding albumin.

 

The Role of Albumin in Heart Disease

Claude-K-LardinoisIn part 2 of this exclusive interview from AACE 2016, Dr. Claude Lardinois discusses why albumin is a driver of cardiovascular disease.

Steve Freed: I woke up with a nightmare and I said to myself (and it goes to what you’ve been saying) microalbumin in the urine can actually be an indicator for heart disease, diabetes, and kidney failure.

Dr. Lardinois: And congestive heart failure too.

Steve Freed: I was told by a doctor that 10% of the population has some form of kidney issues and that if we prevent one person from going on dialysis, that’s a quarter of a million dollars over their lifetime. Just one person. I said to myself. Well, wait a second, we have microalbumin tests right now. I looked into it and you can perform a microalbumin test with blood, you can also do a dip stick in your office. But there is no FDA approved test for home use to detect microalbumin. Now if you remember, we had colon cancer tests where you put a piece of feces in the mail, and we found all these people and we saved millions and millions of dollars.

Dr. Lardinois: I would say two things: one is, I would discontinue using the term microalbumin. Now the reason I say that is I’ve actually asked students or residents what microalbumin is, and do you know what they think it is? It’s a smaller molecule of albumin. It’s a small albumin molecule. There’s a small albumin and a big albumin. Well, there’s not! It’s just albumin, period.

Steve Freed: So I said to myself, let me investigate this. So I went out and I found overseas a test that’s like a pregnancy test.  A plastic container, put two drops of urine in it. If the red line comes up, you’ve got “albumin” in the urine. Obviously if you’re lifting weights, you might have albumin in the urine. If you have a cold, you might have albumin in your urine. So I asked the doctor, he said you know I tried this about 20 years ago, and what they discovered was it was too costly. Well, I found a way to get this thing made for less than a dollar. It has to get FDA approved. My thought is you can send these out and I would send two, maybe even three tests out, and if one was positive, you do another one in a week and if that was positive, you can do another one. If you get two positives then you need to contact your physician and have them do further testing. Because you could be at risk. I know I can’t say that you’re diagnosed. All I can say is you’re at risk and more tests have to be done and you need to contact your physician. Send this out to the self-insured companies that have 10,000 employees, send it out with your tax refund, if the check is no good.

Dr. Lardinois: I’ll share with you, I’ve got a couple of very important things. You said something about nightmares though?

Steve Freed: Well I had a nightmare because of all these people I have to talk to, this doctor and I said a quarter of a million dollars.

Dr. Lardinois: You don’t have diabetes do you?

Steve Freed: No, it’s in my family.

Dr. Lardinois: Because what I tell you is that I tell people that a nightmare or a bad dream is a hypoglycemic reaction. When you said that, I used to do camps for kids and there were kids that would have a 400 blood sugar in the morning and everybody thought they didn’t take their insulin. They had too much insulin and they rebounded. Here’s the issue with albumin…. Albumin in the urine. What do they tell you your albumin in the urine should be? Less than 30. Where did that number come from?

Steve Freed: The albumin test is greater than 20.

Dr. Lardinois: That’s because you have to correct for grams of protein so it actually becomes 30. It’s 20 mg but when you correct for creatinine it’s actually 30. That number of 30 was generated by the nephrologists. What they showed was that if you had less than 30 mg of albumin in your urine, your chances of going onto end stage renal disease was zero, almost zero. If you had between 30 and 300, that’s where they came up with the term microalbumin. It really wasn’t microalbumin, it was just albumin in the 30 to 300 range. You had a small percentage of going into end stage renal disease. If you had more than 300 in your urine, I tell my patients, you better start learning the word nephrologist. Not endocrinologist, because you’re going to do that. But I can tell you, the true value, the goal for albumin in the urine is 7.5 in women and 4 in men.

Steve Freed: You say 4 and 7, what does that mean?

Dr. Lardinois: I’m saying instead of 30 it should be 7.5 for you [Joy], and 4 for you [Steve]. There are studies now, and I will show this data, that once your albumin in the urine is more than 5 mg per gram of creatinine, your mortality starts to go up. When you get to 30, you’ve already doubled your mortality. So you’re twice as likely to die if you have a 30 as a 5, but everybody says it’s normal because you’re less than 30. The other thing they don’t take into account, but I’ve learned from a couple nephrologists here, that they actually are addressing now is you [Steve] versus her, because you have a bigger muscle mass than she does. You’re going to have a seriously lower creatinine because it’s an albumin to creatinine ratio, because you have a bigger creatinine, your numbers actually are going to be lower. But when you correct it for lean body mass, your numbers should be lower, so yours should be 4 and hers is 7.5. But I’m going to do a whole hour on that.

 

Steve Freed: So what do you think of that? I’ve already got a lab, we’re working on it, we’re putting it together, we’re putting together a business plan to develop this and get it FDA approved.

Dr. Lardinois: I think it would be a great idea, but I’m hoping that the FDA and that societies will stop looking at 30 as the normal.

Steve Freed: Where can I get this information?

Dr. Lardinois: Which information?

Steve Freed: That 30 is not normal.

Dr. Lardinois: I can give you all the information you want. I can send you the talk I gave in Hawaii and it’s going to be similar in December, but obviously I’ve got some new information just in the last couple weeks. I always update my presentations.

Steve Freed: I’d like to transcribe it so I can hand it to the National Kidney Foundation.

Dr. Lardinois: I’ve been very adamant. I’ve not got anywhere with it. Even some of them say, what are you talking about, let’s do a physician paper. I said ok fine, but your blood pressure, lipids, continuous glucose monitoring. Why don’t you actually do one on albumin? In fact I even said I would be happy to even chair it, if you were willing to do it, because I think it’s something that’s really important. The problem with albumin right now, is we’ve never designed any good control studies, so all the data we have is observational. Observational studies, that’s the problem with nutrition. All of them are observational studies, and that’s been flawed. So that’s prevented us. Until the FDA will accept albumin as a legitimate marker, and say, ok, we must get below 7.5 in you, we must get below 4 in you, let’s see what happens? I’ll guarantee you, I’m from Nevada but I don’t spend money at the casinos, but I would [spend] some serious money on that. I’ll bet you, I’ll bet $25,000 that if you did a clinical study and you got it below 7.5 in women and 4 in men, you would save a lot of lives.

Steve Freed: That’s going to take time to show.

Dr. Lardinois: Exactly, but they’ve got studies where they’ve done it, but they didn’t want it. It wasn’t part of the end point. But they’ve got studies like Life study which shows normal albuminuria and the death rates up 200% with a “normal” albuminuria. I’ll be happy to send you that.

Diabetes in Control will continue to provide updates as more information becomes available.

Claude K. Lardinois, M.D., FACP, FACE, MACN, is  a professor of medicine at the University of Nevada School of Medicine and  a member of the graduate faculty for Nevada Studies in Nutrition at the University of Nevada, Reno.  

Portions of this interview transcript have been edited for brevity and clarity.

Click here for part 1.

Click here to see the full video.