Overweight Individuals with T2DM | Keto Diet vs Plate Method Diet


Recently a study was conducted by Saslow LR and colleagues to study whether a very low carbohydrate ketogenic diet with lifestyle factors (intervention) or a “Create Your Plate” diet (control) recommended by the American Diabetes Association (ADA) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes mellitus (T2DM).

This article was published in February 2017 in a very reputed journal ‘Journal of Medical Internet Research’. In 2017, the impact factor of this journal was 4.671. For those of you who don’t know what an impact factor is or have never heard of, it simply means the number of times recent articles published in that journal in a year was cited by others. If the impact factor is high, it is considered to be a highly ranked journal.

Now coming back to the study, it was a parallel-group, balanced randomization (1:1) trial. This trial was approved by the University of California, San Francisco, Institutional Review Board and registered with ClinicalTrials.gov (NCT01967992).

In this study, glycemic control, operationalized as the change in glycated hemoglobin (HbA1c) was the primary outcome.

They also assessed body weight, cholesterol, triglycerides, diabetes-related distress, subjective experiences of the diet, and physical side effects.

During the study, the participants were asked to measure urinary acetoacetate (one type of ketone bodies that can be measured in urine) test kits (KetoStix). Basically, there are three types of ketone bodies. Other two types of ketone bodies are acetone and beta-hydroxybutyrate.

The other group i.e. the control group were asked to follow “Create Your Plate” diet recommended by ADA. What does this ADA diet consist of? Well, ADA recommends a low-fat diet which includes green vegetables, lean protein sources, and limited starchy and sweet foods. Most of the doctors worldwide follow ADA guidelines and recommend this particular diet to their patients.

As mentioned earlier the investigators divided the eligible participants into two groups (intervention group and control group).

In fact, when I was diagnosed with T2DM my diabetologist also recommended a low-fat diet with a caloric restriction of 1800 calories. But he never advised me how to restrict my calories to 1800 or what should I eat.  I was totally confused.

Also, he prescribed a couple of oral antidiabetic drugs and a statin. I followed his instructions for a couple of weeks and the result was that within 2 weeks I developed side effects of the drugs. I immediately STOPPED all my medications and started following a keto diet. Finally, I was able to reverse my T2DM. Anyway, that’s a separate story.

Coming back to the study, all the parameters were measured at baseline before randomization in both the groups. Again, all the parameters were measured after 16 and 32 weeks of intervention.

So what conclusions were drawn from this study. Let me list the results of this study in bullet points for better understanding.

  • The investigators observed that there were significantly greater reductions in HbA1cthose who followed the ketogenic diet after 16 as well as 32 weeks
  • Similarly, those who were on keto diet lost more weight than those who followed conventional ADA diet (12.7 kg versus 3 kg)
  • Also, triglycerides level was much lower in the ketogenic group compared to ADA diet followers

This study showed that those who followed a ketogenic diet had several health benefits including lower HbA1c, body weight, and triglyceride levels.

There were few limitations in this study. The number of participants was very less (25 participants) and the follow-up duration of the study was not long.

Despite all limitations, the conclusion we can draw from this study is that low-carbohydrate ketogenic diet and lifestyle changes are beneficial in individuals who are overweight with T2DM.

If you have any queries or any experience to share please type in the comment box. I will try to reply to all your queries.

If you have enjoyed reading this article, I would request you to share with your friends and colleagues who are diagnosed with T2DM. I am sure by reading this article, they will be motivated that it’s not the end of the world if they are diagnosed with T2DM.

With dietary and lifestyle modifications, it is possible to reverse your T2DM.

The Keto Diet for Type 2 Diabetes (How effective is it?)


The conventional approach for Type 2 Diabetes is to manage the condition with medications and diet, based on the American Diabetes Association guidelines, which still includes a lots of high carb foods, along with a low-fat diet and processed vegetable oils. Unfortunately, both science and real-life results show that this protocol just simply does not work. At best, this approach may be better than a junk food diet (but not much better), and have a small shift in blood glucose and other diabetes blood markers if the person has really been abusing their body with junk foods. However, diabetes drugs can often have harmful side effects, and research tells us that the damage to the blood vessels can still occur, even with glucose-lowering diabetes drugs.

While most of general public still keep their bodies fueled on glucose in the form of processed grains, starches, and sugar, (Standard American Diet), others have begun to adopt reduced carb Paleo–and even ketogenic diets that actually reprogram their bodies to the fat burning/fat-fueled machines that our ancestors once had. These kinds of diets are very effective in lowering the amount of glucose circulating in the body, and bringing back insulin sensitivity once again.

What is the difference between a Paleo diet and a Keto diet?

The Paleo diet has been popular the last few years and it is generally a reduced carbohydrate diet compared to the standard Amercian Diet, however “paleo” is only a template for healthy eating, and doesn’t have a specific ratio of carbs like Keto does. However, paleo emphasizes eating foods that our primal ancestors ate: no grains, no dairy, no legumes, no processed foods, and no refined sugar. Paleo does however allow some carbs in the form of sweet potatoes, fruits, starchy vegetables, natural sweeteners like honey, maple syrup and dates. Paleo diets also include grass-fed pastured meats, poultry, eggs, wild caught fish, game and healthy saturated fats.

Is a Paleo diet effective for type 2 diabetes? It is a far cry from the ADA-recommended low-fat/high carb diet and far healthier with its emphasis on fresh veggies, naturally raised proteins, and unprocessed foods, but the Paleo diet can contain variable amounts of carbohydrates and natural sugars, depending on the types of paleo foods you choose to eat. Many versions of Paleo diets include sweet potatoes, or desserts sweetened with dates, honey, molasses, or maple syrup. So, yes, a Paleo diet is a much better choice over the SAD diet, or even the ADA recommended diet, but it’s not always the absolute best choice to lower blood sugar and insulin, depending on the quantity of carbs one chooses to eat on a paleo diet.

On the other hand, the ketogenic diet takes Paleo a step further by restricting carbohydrates to a much larger degree. A keto diet restricts most carbohydrates and all sugar, keeping the resulting glucose in the body consistently low, and forcing your body to burn fats for energy instead of carbs. Keto diets are even more restrictive than Paleo diets as far as carbs go, so in many ways, a keto diet is almost a perfect diet for a diabetic. A keto diet generally allows 20-50 grams of carbohydrates per day. While that is super low compared to the average diet, it can be done, and is easier than you may think.

How a ketogenic diet works for type 2 diabetic

Type 2 diabetes starts when a person is eating large amounts of sugar and carbohydrates. This in turn elevates the body’s serum glucose, creating an increased need for insulin. Over time, the body’s insulin cannot effectively lower the circulating glucose in the body, creating ever higher levels of glucose, insulin, increased body weight, and rising levels of triglycerides. Higher than normal levels of glucose damage blood vessels causing heart disease, kidney disease, blindness and other health issues.

How does a keto diet affect insulin and blood sugar?

When we look at one of the best ways to manage type 2 diabetes, the best and healthiest method is to lower blood sugar by restricting carbohydrates and sugars, in addition to increasing antioxidants and other nutrient-dense foods.

Since a keto diet is a very low carb, low sugar diet, blood sugar stays low, people generally lose weight and the body once again becomes more sensitive to insulin. A keto diet, in comparison to a Paleo diet, allows less carbohydrates and proteins, and adds in more high-quality fats. Because of this drastic dietary transformation, the body quits requiring glucose for energy and instead becomes more efficient in breaking down both dietary fats along with body fat to utilize for energy.

There are many variations on a Paleo diet, but in general a keto diet contains these components:

  • 60-75% of calories from fat (or even more)
  • 15-30% of calories from protein
  • 5-10% of calories from carbohydrates.

The ketogenic diet is not a new dietary fad; it has existed since the 1950’s as a treatment for epilepsy and other health issues. It has recently gained popularity as a way to improve health, increase physical stamina, and lose body fat. A few scientific studies have been conducted on ketogenic diet and diabetes already. Let’s take a look, shall we?

The first study was performed by researchers at Duke University in 2005. Researchers recruited 28 participants with type 2 diabetes who were also overweight. The study lasted 16 weeks. The subjects consumed a low carbohydrate keto diet, aiming for less than 20 grams carbs per day. Diabetics also reduced their medications with medical supervision. There were twenty-one subjects who successfully completed the study. Here’s what they found after only 16 weeks:

  • HbA1c 16% decrease
  • Average 20 lb weight loss
  • Triglyceride levels 42% decrease
  • Ten patients reduced medications, seven stopped medication.

The conclusion of the study was that at keto diet is highly effective at lowering blood glucose, but there should be medical supervision to adjust medications accordingly.

A second study conducted by Stephen Phinney and Jeff Volek, who wrote The Art and Science of Low Carb, showed the positive effects of low carb diet as well. This particular trial shows convincing evidence that a low-carb diet improves blood sugar levels and helps speed weight loss in adults with type 2 diabetes. In almost 60% of participants, diabetes medication was decreased or stopped altogether.

The study, conducted at Indiana University, and published in Journal of Medical Internet Publications, looked at 262 people with type 2 diabetes who were overweight. Participants cut carb intake to 30g a day, while increasing their fats and protein. Patients were also provided nutritional and behavioral counseling, along with digital coaching and medical supervision for medications. Findings after only 10 weeks:

  • HbA1c had a 6.5% decrease
  • BMI decreased by 7%
  • 112 reduced diabetes medications, 21 totally eliminated diabetes medications

Another study of 84 people, looked at the effectiveness of a low-glycemic diet compared to a ketogenic diet, and after 24 weeks looked at key diabetes markers of fasting blood glucose, body mass index (BMI), weight, and Hb A1C. While a low carb, low-glycemic diet is good for controlling diabetes, obviously a keto diet is better.

Low-calorie group

  • Fasting glucose down 16%
  • BMI decreased by 3, average 15lb weight loss
  • .5 reduction in HbA1c

Keto group

  • Fasting glucose down 20%
  • BMI decreased by 4, average 24.5lb weight loss
  • 5 reduction in HbA1c

And this study of 363 overweight or obese participants in the United Arab Emirates looked at the effects of a ketogenic diet on weight loss and diabetes symptoms. 102 of the subjects had type 2 diabetes. One group consumed a low-calorie diet and the other consumed a keto diet. Both groups had nutritional trainer and exercise.

Study subjects were measured on:

  • Body weight
  • BMI
  • Waist circumference
  • Blood glucose
  • HbA1c
  • Cholesterol, LDL, HDL, triglycerides
  • Uric acid, urea, creatinine

After 24 weeks, both groups had improved in all metrics but the keto group had far more significant results. Diabetic medications were decreased to half and some were discontinued for those on the ketogenic diet.

It is important to note for those beginning a ketogenic diet, the drop in glucose can be quick, so it is very important to monitor blood glucose frequently and to have a physician monitor the diabetes medications.

Ketogenic diets are higher in saturated fats, something the American Diabetes Association actually warns diabetics to avoid.  Research, however, shows favorable lipid results on a high fat diet.

In another study, researchers looked at 83 subjects who were divided into three groups of equal calories. One group followed a very low-fat diet, one group followed a diet high in unsaturated fats, and the third group ate a very low carb and high saturated fat diet.

At the end of the 12-week study, all three groups had lost similar amounts of body fat and weight. However, the Low Carb Ketogenic diet group also had the lowest triglyceride levels, higher HDL, and lower glucose and insulin levels.

Very Low-Fat Group:

  • Triglycerides decreased by 4%
  • Insulin levels decreased by 15.1%

High Unsaturated Fat Group:

  • Triglycerides down by 9.6%
  • Insulin levels decreased by 18.7%

Ketogenic Diet Group:

  • Triglycerides decreased by 40%
  • Insulin levels decreased by 33.6%

Key results indicate that ketogenic diets do not increase the risk of heart disease or high cholesterol. Keto diets have shown to significantly decrease harmful lipids including triglycerides and LDL cholesterol, compared to other equal calorie/low fat diets.

Conventional Diabetic Diets vs. Ketogenic Diets  

In spite of all the positive research on ketogenic diets for diabetes, most doctors and dietitians still recommend high carb diets to manage diabetes. A typical medically supervised diet recommended for a type 2 diabetic would include 45-60g carbohydrates at every meal, plus 15-30g of carbs for snacks. Seriously??

Most dietitians and doctors feel that even though the ketogenic diet is effective, most people will not be able to stick to it. And yes, this is somewhat true, although with the emerging popularity of the ketogenic diet, more and more options are available, including recipes, books, blogs, cooking classes, etc. that feature delicious keto meals and snacks. The nature of a keto diet is to keep blood sugar in a low and stable range, and because of this, it is much easier to control appetite and the “munchies”.

Ketogenic diets can be crucial to the successful healthy management of type 2 diabetes. In a recent critical evaluation of literature on carbohydrate restriction and diabetes, a group of 26 leading researchers compiled 12 points of evidence published in the January 2017 Journal of Nutrition, pointing to the use of low carbohydrate diets as the primary dietary treatment of type 2 diabetes. Key points include:

  • Dietary carbohydrate restriction has the greatest effect on decreasing glucose levels.
  • The current epidemic of obesity and diabetes has been caused almost entirely by an increase in carbohydrates.
  • Type 2 diabetics can adhere to a ketogenic diet at least as easily as they can most other diets, and often better.
  • Measured saturated fats in the blood are affected more by dietary carbohydrate intake, than dietary lipid intake.
  • Dietary carbohydrate restriction is the most effective way to reduce serum triglycerides, LDL cholesterol and increasing HDL cholesterol.

Bottom line is that lowering glucose by strictly reducing carbohydrate intake in a ketogenic diet has the most positive effects on diabetes markers, without any of the negative side effects of pharmacological treatments.

All of the available evidence thus far suggests that a keto diet is one of the safest and most effective ways to control or reverse type 2 diabetes. Diabetes patients should always notify their physicians of dietary changes and have medications and blood sugar monitored closely.

Following a strict carbohydrate-restricted, ketogenic diet is key initially, but once your body is adept at fat burning, you may be able to ease up slightly on the daily carbohydrate count. Generally, following a strict keto diet for about 2 months will help your body adapt to burning fat. Rather than stressing out about keeping carbs consistently below 20-30g, it may be easier to give yourself a safe zone to follow. Perhaps one day you eat less, another day you eat more. As long as you generally stick to low carbohydrates, (below 50-60g per day) your body will continue to be fairly efficient in burning fat for energy and keep blood glucose low.

The end result is a healthier body, weight loss and a clear head.  Note that while transitioning to a higher fat ketogenic diet for a type 2 diabetic, you must work closely with your physician to monitor and consistently lower your insulin needs.  With less carbs, you’ll need less insulin.  If you follow keto closely and keep limiting carbs, most Diabetics can get off all medications at some point in time, but it needs to be carefully monitored.

References
https://www.perfectketo.com/keto-diet-vs-paleo-diet-ketosis-better-paleo/

https://www.marksdailyapple.com/keto-and-type-2-diabetes/

Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services; 2014.
American Diabetes Association. “Nutrition Recommendations and Interventions for Diabetes–2006 A position statement of the American Diabetes Association.”Diabetes care 29.9 (2006): 2140-2157.
Emerging Risk Factors Collaboration. “Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies.” The Lancet 375.9733 (2010): 2215-2222.
O’Gara, Patrick T., et al. “2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.” Journal of the American College of Cardiology 61.4 (2013): e78-e140.
Aguiree, Florencia, et al. “IDF diabetes atlas.” (2013)
“Update 2014”. IDF. International Diabetes Federation. Retrieved 29 November 2014.
Geiss LS, Wang J, Cheng YJ. Thompson TJ, Barker L; Li Y, Albright AL, Gregg EW. Prevalence and incidence trends for diagnosed diabetes among adults aged 20 to 79 years, United States, 1980-2012. JAMA 2014; 312:1218-1226.
Yancy Jr, William S., et al. “A low-carbohydrate, ketogenic diet to treat type 2 diabetes.” Nutr Metab (Lond) 2 (2005): 34.
Westman, Eric C., et al. “The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus.” Nutr Metab (Lond) 5 (2008): 36.
Hussain, Talib A., et al. “Effect of low-calorie versus low-carbohydrate ketogenic diet in type 2 diabetes.” Nutrition 28.10 (2012): 1016-1021.
Noakes, Manny, et al. “Comparison of isocaloric very low carbohydrate/high saturated fat and high carbohydrate/low ‘saturated fat diets on body composition and cardiovascular risk.” Nutrition & metabolism 3.1 (2006): 7

Adding Glucagon to Artificial Pancreas May Cut Hypoglycemia


Possible reduction in hypoglycemia in pooled small outpatient studies

 Using both a glucagon and insulin pump integrated with continuous glucose monitoring could reduce nighttime hypoglycemia in type 1 diabetes, a combined analysis of two small outpatient studies suggested.

Overnight use of the dual-hormone system was associated with less time spent in the hypoglycemic range under 72 mg/dL, at 1.0% compared with 3.1% with the single-hormone system and 5.1% with conventional insulin pump therapy, Ahmad Haidar, PhD, of McGill University in Montreal, and colleagues found.

The difference was almost entirely accounted for during the first half of the night, the time when glucagon was administered, whereas insulin delivery was otherwise similar between the two artificial pancreas systems.

Those were the findings from two randomized open-label crossover trials, one with 21 adults and seven children in a home setting using Medtronic pumps and sensors for two nights per intervention and the other with 33 children in a camp setting using Dexcom sensors and Roche pumps for 3 nights per intervention.

Combined analysis was reported here at the American Diabetes Association annual meeting, along with simultaneous publication of the pediatric camp study online inLancet Diabetes and Endocrinology.

The two artificial pancreas systems yielded similar overall glucose levels, both averaging 122 mg/dL compared with 140 mg/dL with conventional pump therapy.

Time spent at night in the hyperglycemic range over 144 mg/dL was 21% with the dual system, 23% with the single-hormone system, and 48% with conventional pump therapy.

The difference in nocturnal hypoglycemia was not significant in the pediatric study on its own, given the higher bar for statistical significance with multiple looks.

That study used a research-level set-up, with the kids’ continuous glucose monitors reading out to a sensor set outside the camp tent every 10 minutes, which was then entered manually by study staff into a tablet computer to run a dosing algorithm for the artificial pancreas systems that was then used to manually deliver the medications via remote control.

The researchers suggested that their findings warrant larger, longer studies with the goal of a fully integrated system.

Such a system would be more complex and more expensive, Jessica R. Castle, MD, of the Oregon Health & Science University in Portland, cautioned in an editorial accompanying the Lancet paper.

“Many advancements are needed to make a dual-hormonal automated system commercially viable,” she wrote, “including the approval of a stable glucagon formulation, a dual-chamber pump for combined storage and delivery of insulin and glucagon, and preferably a specialized infusion set that allows for combined delivery through a single insertion site.

“Despite these hurdles, the ongoing development of dual-hormonal systems is needed. Until a truly ultra-rapid insulin is available, an insulin-only system will be suboptimal, particularly in situations where insulin needs drop rapidly, such as during exercise.”

Statins for Young T1D Patients, Too?


Type 1 diabetes patients younger than 40 may be candidates for statin use, as guidelines recommend after age 40, researchers suggested.

Under the American Heart Association/American College of Cardiology definition, the 10-year cardiovascular risk was about 5% for type 1 diabetes patients ages 30 to 39 and about 13% in those ages 40 to 44, Rachel G. Miller, MD, of the University of Pittsburgh, and colleagues found.

Adding coronary revascularization to that definition — which also included cardiovascular death or nonfatal stroke or myocardial infarction — brought the 10-year risk to nearly 7% for type 1 diabetes patients in their 30s, the group reported here at the American Diabetes Association meeting.

Although still a little shy of the 7.5% 10-year risk threshold recommended for statin treatment in the guidelines, the 20% of the cohort already on a statin before age 40 was excluded along with a number of events that happened before the start of follow-up.

“We conclude that young adults aged 30 to 39 years with 20 or less years’ type 1 diabetes duration are at sufficiently high atherosclerotic cardiovascular disease risk to merit statin therapy,” the group concluded in their poster presentation.

Both the AHA/ACC and the American Diabetes Association guidelinesrecommend statins after 40 for essentially all diabetes patients and support possible use for younger people with cardiovascular disease risk factors.

“We’ve been comfortable with the concept that anybody over the age of 40 with type 2 should be on a statin and by extrapolation anybody who has type 1 over the age of 40 should be recommended for statins,” commentedNaveed Sattar, MD, a metabolic medicine specialist at the University of Glasgow, Scotland.

“What we now need is good guidance: Who are these people under 40 with type 1 who should get a statin, and how do we recognize them?” he toldMedPage Today.

There isn’t enough data to develop a risk score for type 1 diabetes yet, he noted. Lifetime risk might be a better criterion in that population than the 10-year risks, which are heavily predicated upon age and which underpin current guidelines, Sattar noted.

“I think in the next 2 or 3 years either from national databases within Scandinavia or Scotland we’re going to have a type 1 diabetes risk score that might allow us to look at this question,” he suggested.

Comparisons with the general population in the surrounding county showed huge elevations in risk with type 1 diabetes even at these early ages, but absolute event numbers were small in Miller’s study.

Among the 517 people under age 45 without pre-existing atherosclerotic cardiovascular disease followed from 1996 to 2011 in the Pittsburgh Epidemiology of Diabetes Complications study (a prospective group of childhood-onset cases seen at a single center soon after diagnosis):

  • One event occurred in 20- to 29-year-olds
  • 18 accrued in those in their 30s
  • 22 occurred in participants in their early 40s

The fatal coronary artery event and nonfatal stroke or MI rates were 134 per 100,000 in the cohort ages 20 to 29, 502 per 100,000 people in their 30s, and 1,336 per 100,000 in the 40 to 44 age range.

Sattar cautioned against overinterpreting the “very crude analysis.”

Anti-hyperglycemic drug selection, sequence for type 2 diabetes addressed in ADA/EASD position statement update.


A revised position statement on the management of hypoglycemia in patients with type 2 diabetes, updated upon request from the American Diabetes Association and the European Association for the Study of Diabetes, is published in Diabetes Care.

The writing group that penned the guidelines published in 2012, when a paucity of comparative effectiveness research existed on the long-term treatment outcomes of anti-hyperglycemic drugs, reconvened from June to September 2014 to incorporate data from recent clinical trials.

“An entirely new statement was felt to be unnecessary,” according to the writing group. “Instead, the group focused on those areas where revisions were suggested by a changing evidence base.”

Silvio E. Inzucchi, MD, of Yale University School of Medicine, New Haven, Connecticut, with co-chair David R. Matthews, MD, University of Oxford, United Kingdom steered members’ input to address critical areas, including glycemic targets, therapeutic options, implementation strategies, other considerations and future directions.

Silvio Inzucchi

Silvio E. Inzucchi

The experts emphasized that studies have determined that reducing hyperglycemia decreased both the onset and progression of macrovascular complications, but they noted that the impact of glucose control on cardiovascular complications remains uncertain and stressed the importance of an individualized approach.

“Instead of a one-size-fits-all approach, personalization is necessary, balancing the benefits of glycemic control with its potential risks, taking into account the adverse effects of glucose-lowering medications (particularly hypoglycemia), and the patient’s age and health status, among other concerns,” they wrote.

The researchers noted that the availability of sodium glucose cotransporter 2 (SGLT2) inhibitors presents a major change in treatment options since the previous publication. They underscored that earlier concerns about thiazolidinediones (TZD) and bladder cancer have been allayed; however, they advised that dipeptidyl peptidase-4 (DPP-4) inhibitors be used cautiously in light of potential cardiovascular effects and highlighted the pancreatic safety concerns in this class as well as in glucagon-like peptide-1 (GLP-1) receptor agonists.

“The use of any drug in patients with type 2 diabetes must balance the glucose-lowering efficacy,

side-effect profiles, anticipation of additional benefits, cost and other practical aspects of care, such as dosing schedule and requirements for glucose monitoring,” they wrote.

The experts highlighted recent calls to relax prescribing policies to extend the use of metformin — still the first-line choice for monotherapy — in patients with mild to moderate kidney disease, and encouraged due caution for renal insufficiency when considering second-line agents.

In addressing dual and triple combination therapies, the researchers noted that no evidence-based recommendation can be made for using SGLT2 inhibitors in conjunction with GLP-1 receptor agonists without data. Although clinicians can look to additional drugs to treat patients with HbA1c levels well above target ≥9% (≥75 mmol/mol), no proven advantage has been shown by achieving a glycemic target more quickly, according to the writing group.

“As long as close patient follow-up can be ensured, prompt sequential therapy is a reasonable alternative, even in those with baseline HbA1c levels in this range,” they wrote.

ADA: New standards of care released


The newest revised Standards of Medical Care from the American Diabetes Association recommend a less stringent diastolic blood pressure target for people with diabetes, according to a press release from the association.

Further, moderate or high doses of statins are recommended for all people with diabetes to coincide with recent changes to guidelines for cardiovascular risk management from the American College of Cardiology and American Heart Association.

“The big change here is to recommend starting either moderate or high-intensity statins based on the patient’s risk profile rather than LDL level,”Richard W. Grant, MD, MPH, of the Kaiser Permanente Division of Research, said in the release. “Since all patients with diabetes are at increased risk, it is just a matter of deciding whom to start on moderate versus high-intensity statin doses.”

Richard W. Grant

Richard W. Grant

A moderate-intensity statin is recommended for people with diabetes younger than 40 years, or those aged 40 to 75 with no addition CV risk factors. A high-intensity statin is recommended for all ages of people with CV risk factors as well as those aged 40 to 75 with additional CV risk factors.

“While observational studies find that lower blood pressure generally seems to be better, the higher quality randomized trial evidence most strongly supports the treatment target of 90 mm Hg,” Grant said.

Other feathers of the Standards of Medical Care include the following:

  • Lower BMI cut point for screening of Asian Americans with overweight or obesity to 23 kg/m2;
  • New section highlighting diabetes during pregnancy;
  • <7.5% HbA1c target for children and adolescents with diabetes;
  • No support for the use of e-cigarettes;
  • Resistance training for all people with diabetes at least twice a week, unless otherwise instructed by their physician;
  • And revised CDC immunizations guidelines for adults aged at least 65 years who have not received apneumococcal vaccine to receive two separate vaccines: 13-valent pneumococcal conjugate vaccine (Prevnar 13, Pfizer), followed by a dose of the 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23, Merck).

 “We’ve revised our recommendations, as we do every year, to reflect the best and most current research affecting the treatment and care of people with diabetes,” Jane Chiang, MD, the ADA’s senior vice president for Medical Affairs and Community Information, said in the release. “Health care providers know that the Association Standards contain the most up-to-date information. However, we also wanted to help readers navigate through the information overload, and felt that a new format would enable easier access. Ultimately, our goal is to improve the lives of those who are living with the disease.”

ADA guidelines may lead to missed diagnosis of type 2 diabetes in youth.


Results from a cross-sectional survey indicated that health care providers are more likely to order HbA1c and fewer fasting glucose tests when screening adolescents for type 2 diabetes based on the guidelines recommended by the American Diabetes Association released in 2010. This approach has the potential for more missed diagnoses for prediabetes and diabetes in children, in addition to increased costs, according to Joyce M. Lee, MD, MPH, and colleagues.

“A number of studies have shown that HbA1c has lower test performance in pediatric compared with adult populations, and as a result, increased uptake of HbA1c alone or in combination with non-fasting tests could lead to missed diagnoses of type 2 diabetes in the pediatric population,” Lee, an assistant professor of pediatric endocrinology and health services research at the Child Health Evaluation and Research Unit at the University of Michigan, said in a press release.

The mail survey was randomly sent to a sample of 1,400 United States pediatricians and family practitioners.

The overall response rate was 52% (57% for pediatricians and 48% for family practitioners); the most commonly ordered tests were fasting glucose and HbA1c, researchers wrote. At least 58% of physicians ordered HbA1c; 35% ordered HbA1c in conjunction with fasting tests; and 22% ordered HbA1c alone or with nonfasting tests, according to data.

However, only 38% of health care providers were aware of the 2010 ADA-recommended HbA1c screening guidelines, researchers wrote. After being made aware of those recommendations, 67% reported they would change their screening practices; based on the context of the guidelines, 84% reported they would subsequently order HbA1c tests and not glucose tests.

“Greater awareness of the 2010 ADA guidelines will likely lead to increased uptake of HbA1c and a shift to use of non-fasting tests to screen for adolescents with type 2 diabetes. This may have implications for detection rates for diabetes and overall costs of screening,” Lee said in the release.

Source: Endocrine Today

Identifying post-partum diabetes after gestational diabetes mellitus: the right test.


Post-partum glucose testing is recommended for women who had gestational diabetes mellitus during pregnancy to identify those with persistent glucose intolerance. Guidelines from several medical organisations disagree about which glucose test should be used and when.

Traditionally, glucose testing in women who had gestational diabetes is done 6 weeks post partum, because of the coincident health-care visit and, theoretically, to allow the temporary increases in glucose during pregnancy to return to normal. However, Lawrence and colleagues1 reported that fasting plasma glucose (FPG) and postprandial glucose (measured by a 75 g, 2 h oral glucose tolerance test [OGTT]) concentrations assessed before 6 weeks are not higher than those obtained 6—12 weeks post partum, suggesting that earlier testing would not lead to falsely increased measurements. After the first measurement, testing is recommended from annually to every 3 years (table). Although few studies have compared the benefits of testing every year or every 3 years, mathematical models suggest that, if FPG is measured, annual testing might yield the lowest cost per case, whereas if OGTT is used, testing every 3 years would have the lowest cost.2

The HbA1c test can identify individuals at risk for future diabetes and diabetes complications, is easily done, and has little intra-individual variation in people who have not recently given birth.3 Additionally, HbA1c concentration is not known to be affected by breastfeeding during the actual blood draw, unlike fasting or postprandial glucose.4 However, because HbA1cconcentrations 6 weeks post partum could be affected by perinatal haemoglobin shifts and prenatal treatments, HbA1cmeasured post partum correlates weakly with glucose concentrations.5 Therefore, the American Diabetes Association has recommended that HbA1c should not be used as a measure of blood glucose concentration at the first post-partum visit (table).3 Whether or not it is used at subsequent visits was not addressed in the guidelines,3 because data for several years after pregnancy are scarce. Notably, measurement of HbA1c in addition to FPG does not increase sensitivity or specificity 1 year post partum.6

Thus, the primary choice for post-partum glucose testing should be either FPG measurements or the OGTT. The postprandial glucose test identifies a different population of women with glucose dysregulation from the FPG test,7 and therefore the OGTT will always have greater sensitivity than FPG measurements alone. However, values obtained by the postprandial glucose test show variability—sometimes exceeding 15% within individuals.8 Moreover, the OGTT has logistical difficulties, such as a glucose challenge and the need for at least two blood draws in 2 h as opposed to one draw after fasting with FPG measurements.

Several questions about whether FPG measurement or the OGTT should be used are relevant. Will more women comply with a FPG test than an OGTT? What proportion of women who refuse an OGTT but agree to an FPG test is identified as having impaired fasting glucose or diabetes? Do these women justify not identifying those who have an isolated 2 h glucose measurement, as measured by OGTT? Systematic information about who refuses an OGTT but accepts an FPG test is not available. In one series, a third of women with glucose dysregulation had normal FPG concentrations.7 This finding implies that testing of post-partum glucose concentration by FPG only is justified only if about 30% more women with impaired fasting glucose are identified as a result of the more straightforward logistics involved in an FPG test than by the OGTT.

The diagnostic test used for gestational diabetes is relevant to the choice of post-partum glucose test. Specifically, when less stringent criteria (ie, lower cutoff for glucose concentration) are used, more women will be diagnosed with gestational diabetes, and the overall population of patients with gestational diabetes will have lower glucose levels and be at lower risk for post-partum diabetes. Indeed, prevalence of post-partum glucose intolerance decreases from 16% when Carpenter and Coustan criteria (lower glucose cutoffs) are used to 8% when National Diabetes Data Group criteria (higher glucose cutoffs) are used.1 Thus, if more women are diagnosed with gestational diabetes—ie, the glucose cutoffs are decreased during pregnancy—the benefit of a post-partum OGTT as opposed to an FPG test only will be reduced. Because International Association of Diabetes and Pregnancy Study Group criteria identify more women with gestational diabetes than did previous criteria,3 these women will, on average, have less severe glucose intolerance, and the relative benefit of an OGTT post partum might be decreased. Notably, women diagnosed with gestational diabetes by postprandial values alone would be most likely to be identified with a post-partum OGTT.

When deciding on a post-partum glucose testing strategy, the provider and patient should also consider whether the woman plans on becoming pregnant again; a more sensitive test for glucose intolerance (ie, the OGTT) could lead to changes in lifestyle or medication use that will reduce risk in future pregnancies. The provider and patient should also consider whether the woman had isolated increases in postprandial glucose concentrations during pregnancy; if so, the OGTT would be a more sensitive diagnostic strategy post partum. The answers to these questions will help to establish the frequency and choice of test, while uniformity in the guidelines for diagnosis of gestational diabetes, and data from randomised trials and cohort studies that quantify post-partum diabetes risk in affected women are awaited.

Source: Lancet

 

HbA1c Inadequate to Assess Diabetes Care Across Specialties.


New findings suggest that simply using HbA1clevels to assess the performance of individual physicians or healthcare systems in diabetes management may be misleading or inaccurate.

Endocrinologists typically see more complex patients who require more time to improve their glycemic control, which makes their performance look worse when judged solely by HbA1c levels.

But new data reported here at the American Diabetes Association 2013 Scientific Sessions show that when diabetes patients are grouped by medication use — a proxy for complexity and stage of disease — HbA1c levels for patients cared for by endocrinologists are the same as or better than those for individuals seen by general internists.

Lawrence S. Phillips, MD, professor of medicine in the division of endocrinology at Emory University, Atlanta, Georgia, who reported the findings in a poster at the meeting, said looking at patients by medication group shows there is very little difference between the performance of specialists and generalists.

“The message is really for the payers and the government… They need to do something like this. They need to have some conservative way to give the provider a chance to improve things, and then they need to compare apples to apples. Just looking at A1c is not sufficient,” Dr. Phillips told Medscape Medical News.

Poster session moderator Sanjeev Mehta, MD, MPH, director of quality at Joslin Diabetes Center, Boston, Massachusetts, agrees. “Dr. Phillips’s data demonstrated that endocrinologists, in the practice setting he evaluated, were seeing patients with higher HbA1c levels. While this suggests appropriate referrals by primary-care physicians to optimize glycemic control, it also supports Dr. Phillips’s conclusion that an outcome-based quality measure [such as HbA1c] may be inadequate when assessing the quality of diabetes care across all providers, especially endocrinologists,” he said.

Dr. Mehta noted that the Agency for Healthcare Research and Quality (AHRQ) has endorsed theadoption of more sophisticated quality metrics, including linked action measures such as appropriate medication use, which would assess outcomes in the context of the care provided.

“I strongly believe this is the direction that all stakeholders in the diabetes community need to be [following to evaluate] high-quality diabetes care,” he told Medscape Medical News.

Comparing Apples to Apples Is Best Approach

Dr. Phillips and colleagues obtained Emory Healthcare data for a total of 5880 diabetes patients cared for by 8 endocrinologists and 8 general internists over a 24-month period. The proportion of patients whose most recent HbA1c was 7% or above was higher for the endocrinologists than for the general internists, 51% vs 38%.

Subsequent analysis was restricted to the 3735 patients who had been seen 3 or more times in the past 24 months and at least once in the prior 12 months. This group was divided into 3 groups by medication use: Those using only oral medications and/or incretin-based drugs (1880), those using basal insulin (with or without oral medications/incretins, 324), and those also using mealtime insulin in addition to basal insulin, with or without other medications (1531). The latter group included patients with type 1 diabetes, Dr. Phillips told Medscape Medical News.

Overall control was poorer among the insulin-using patients, with HbA1c levels of 7% or higher in 66% of those using mealtime insulin and 55% of individuals using basal insulin, compared with just 21% of those not using insulin (P < .0001 for trend). And endocrinologists had more patients on insulin than did the general internists, with 53% vs 22% using mealtime insulin (P < .0001), 10% vs 7% using basal insulin (P = .02), and 37% vs 71% not using insulin (P < .0001), respectively.

When examined by treatment group, however, the non–insulin-using patients of the endocrinologists actually had better HbA1cs: 18.8% of their patients had levels at or above 7% vs 23.4% of the general internists’ patients.

For the 2 insulin treatment categories, there was no significant difference between the endocrinologists and the internists. In both groups, just over half of the patients had HbA1cs 7% or above (= .6) as did about two thirds of those using mealtime insulin (= .9).

New Models Needed for Evaluating Care

Dr. Mehta told Medscape Medical News:”I think this poster highlighted the importance of adopting more sophisticated quality metrics, such as linked action measures, and the importance of ongoing collaboration with specialists and specialty centers in the care of adults with diabetes.

“Specialists and specialty centers may have an opportunity to translate best practices to their referring primary-care physicians, who will continue to care for the majority of adults with diabetes in the United States,” he added.

And specialists should be rewarded, not penalized, for their particular patient mix. “Those providers and practices that care for more complex patients need to be recognized, even reimbursed, for their ability to make meaningful improvements in health outcomes in high-risk patients,” he observed.

Dr. Phillips told Medscape Medical News that “diabetes is a heavy-duty proxy for healthcare systems as a whole, because a lot of people have diabetes, and it’s an expensive disease.”

He believes his “apples-to-apples” comparison could have implications for other areas of medicine as well. “I think it’s an important concept. You would think it applies to blood pressure, cholesterol, all the things that doctors do. We think this is a model for how you evaluate care.”

Source: http://www.medscape.com

Empagliflozin provided sustained glycemic control, weight loss in type 2 diabetes.


  • The novel investigational sodium-glucose cotransporter 2 inhibitor empagliflozin demonstrated 90 weeks of sustained glycemic control and weight loss in patients with type 2 diabetes. Study researcher Thomas Hach, MD, a senior medical director at Boehringer Ingelheim, spoke withEndocrine Today about the data presented during a late-breaking session here.

“We feel there is an important obligation for us to understand patient benefits: to look at benefit-risks and to really understand which patients will benefit most or where there could possibly be limitations,” Hach said.

In active-control studies, Hach told Endocrine Today that he and colleagues saw comparable efficacy. They conducted a randomized, open-label, 78-week extension study on empagliflozin (Boehringer Ingelheim/Eli Lilly and Company).

They investigated empagliflozin 10 mg (n=81), 25 mg (n=82) or metformin (n=80) as monotherapy, or empagliflozin 10 mg (n=71), 25 mg (n=70) or sitagliptin (n=71; Januvia, Merck) as add-on to metformin in patients with type 2 diabetes who also completed one of two 12-week randomized control trials.

According to 90-week data, adjusted mean changes in HbA1c from baseline were: –0.51% (empagliflozin 10 mg), –0.60% (empagliflozin 25 mg) and –0.64% (metformin); and –0.61% (empagliflozin 10 mg), –0.74% (empagliflozin 25 mg) and –0.45% (sitagliptin).

Further data indicate adjusted mean changes in fasting plasma glucose were: –32.4 mg/dL (empagliflozin 10 mg), –28.1 mg/dL (empagliflozin 25 mg), and –25.9 mg/dL (metformin); –23.3 mg/dL (empagliflozin 10 mg), –31.8 mg/dL (empagliflozin 25 mg), and –11.7 mg/dL (sitagliptin).

Moreover, changes in weight were reported as: –2.1 kg (empagliflozin 10 mg), –1.9 kg (empagliflozin 25 mg), and –0.9 kg (metformin); –2.9 kg (empagliflozin 10 mg), –3.8 k (empagliflozin 25 mg), and –0.6 kg (sitagliptin).

“If I was still in clinical practice, I would look forward to having something new in my armamentarium. Unfortunately, there’s still a huge unmet need in diabetes,” Hach said.

The medication was well tolerated, and the most common adverse events associated with empagliflozin include urinary tract and genital infections. Hach said clinicians should use caution with elderly patients or those with renal impairment because those patients are more susceptible to adverse events.

In March, a new drug application for empagliflozin was submitted to the FDA. Further data will be presented at the American Diabetes Association Scientific Sessions in Chicago next month, Hach said. – by Samantha Costa

For more information:

Ferrannini E. Abstract #1102. Presented at: the AACE Annual Scientific and Clinical Congress; May 1-5, 2013; Phoenix.

Source: Endocrine today