Type 2 Diabetes: Medical Groups Disagree on What Your A1c Goals Should Be


A1c goals for type 2 diabetes

The American College of Physicians (ACP) has written a guidance statement for providers to use when selecting targets for pharmacologic treatment of type 2 diabetes.

In other words, they share how aggressive clinicians should be when it comes to using medications to treat type 2 diabetes.

The American College of Physicians Guidance Statement

1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients’ preferences, patients’ general health and life expectancy, treatment burden, and costs of care.

2: Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes.

3: Clinicians should consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%.

4: Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population.

Diabetes Medical Associations Disagree

Medical associations whose focus is diabetes do not agree with the ACP’s guidance statement.

The president of the ACP, Dr. Jack Ende explained in a statement that “ACP’s analysis of the evidence behind existing guidelines found that treatment with drugs to targets of 7 percent or less compared to targets of about 8 percent did not reduce deaths or macrovascular complications such as heart attack or stroke but did result in substantial harms,”

“The evidence shows that for most people with type 2 diabetes, achieving an A1C between 7 percent and 8 percent will best balance long-term benefits with harms such as low blood sugar, medication burden, and costs,” he added.

Do These Recommendations Prioritize Individualized Care?

It’s reasonable to wonder that if taking medications is not a burden and costs are not an issue and low blood sugar risk is appropriately managed, is an A1c between 7 and 8 percent less desirable than one closer to non-diabetic levels? Type 2 diabetes is a serious disease and a 7% A1c would lead to its diagnosis, meaning that an A1c between 7 and 8 is not ideal for good health.

Yet, the reality is that these burdens do exist for a great many patients. The ACP seems to make the case that when burdens increase and patients do not reap additional health benefits in return, the extra medication intervention is not worthwhile but actually detrimental.

It makes sense to seek guidance from statistics. The problem is when these recommendations trump individualized care. It may make sense for one type 2 patient to keep a higher A1c level based on their unique circumstances but it would be an irresponsible measure for a provider not to share the risks of the higher A1c with any patient and leave them inadequately treated.

The ACP is not against a more ideal end result, however.

“Although ACP’s guidance statement focuses on drug therapy to control blood sugar, a lower treatment target is appropriate if it can be achieved with diet and lifestyle modifications such as exercise, dietary changes, and weight loss,” said Dr. Ende. Perhaps this signals a change in focus from aggressive drug therapy to lifestyle interventions or perhaps more of an an emphasis on a healthier balance between the two.

The American Diabetes Association’s chief medical officer Dr. William Cefalu told NPR News that they disagree with the ACP’s guidelines and stand by their own. He said that new drugs are effective in managing blood sugar and carry less risk for low blood sugar and some of them help lower body weight and improve cardiovascular risk factors–a win/win for patients who need to address all three common issues.

Former president of the American Association of Endocrinologists, Dr. George Grunberger told NPR that “The moment your glucose goes above normal, it’s incurring damage to the back of the eye, to kidneys and to nerves, especially in your feet,” and that he worries these guidelines will effectively tell physicians not to worry too much about their patients elevated A1c levels.

The Endocrine Society released a statement as well, sharing their strong disagreement with the ACP’s statement. They pointed out in a press release that the ACP’s “recommendations do not consider the positive legacy effects of intensive blood glucose control confirmed in multiple clinical trials, particularly for those newly diagnosed with type 2 diabetes, and, therefore, are not reflective of the long-term benefits of lower A1C targets.”

The recommendations might prove costly if physicians do not treat each individual on a case-by-case basis. Physicians and patients need to have very candid talks about what is desired because not all patients want or are capable of the same things.

So Who is Right?

The ACP has a point about how few benefits are often seen at various points of treatment which barely outweigh burdens incurred by type 2 diabetes patients who are treated aggressively with medications.

However, other medical associations who recommend getting A1c levels lower are also accurate in recommending for lower targets. Blood sugar levels above normal do indeed cause damage, even if only slightly elevated. Patients have a right to be aware of that fact and to get help from their provider in achieving normal blood sugar levels, if possible.

Should providers encourage normal blood sugars or should they follow their patient’s lead? The ACP’s stance suggests the patient needs to advocate for the best blood sugar outcomes they can get. Will this guidance statement lead patients to leave providers who want them to settle at higher A1c targets? Finding new providers is often more than an inconvenience. Will this stance ultimately help or hurt patients?

As studies indicate, the future points to more emphasis on lifestyle habits as well as better medications. It’s also likely that continuous glucose monitoring devices, known as CGM are going to be used more in type 2 diabetes and become powerful aids. An individual with type 2 diabetes using a CGM will be able to find out exactly what certain foods, stress, and exercise does to their blood sugar levels and be motivated to act accordingly.

Perhaps a good question to ask is what motivations do people with type 2 diabetes have to rely more on lifestyle interventions versus aggressive medication protocols?

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Young Adults With Type 1 Diabetes Show Abnormal Brain Activity


Having diabetes may affect the way our brains work. Research is taking place to find out exactly how this occurs.

In a recent study, researchers describe how tying diabetes to cognitive impairment is tricky because many people with diabetes have other conditions like high blood pressure and obesity, which also affect cognition. That’s why they conducted a study in young adults with and without type 1 diabetes “who were virtually free of such comorbidities,” the study authors wrote in their abstract.

brain activity

Christine Embury is a graduate research assistant at the Center for Magnetoencephalography (MEG) at the University of Nebraska Medical Center. She worked with Dr. Wilson, the study’s lead author and was kind enough to answer some questions.

In layman terms, she explains that “neural processing” is brain activity. “In our work, we relate brain activity in specific brain regions to task-specific cognitive processes, like working memory. Widespread brain networks are involved in this kind of complex processing including regions relating to verbal processing and attention, working together to accomplish task goals,” she writes.

Young, Healthy Type 1 Adults Tested

They matched two groups, one with and one without type 1 diabetes, on major health and demographic factors and had them all do a verbal working memory task during magnetoencephalographic (MEG) brain imaging. For the group with type 1 diabetes, the mean years of diabetes duration were only 12.4.

The researchers hypothesized that those with type 1 diabetes would have “altered neural dynamics in verbal working memory processing and that these differences would directly relate to clinical disease measures,” they wrote.

Higher A1c and Diabetes Duration May Alter Brain Activity

They found that those with type 1 diabetes had much stronger neural responses in the superior parietal cortices during memory encoding and much weaker activity in the parietal-occipital regions during maintenance compared to those without type 1 diabetes.

Diabetes duration and glycemic control were both “significantly correlated with neural responses in various brain regions,”

Embury explained that their findings suggest that “the longer one has the condition, the more the brain has to work to compensate for deficits incurred.” Higher A1c levels were also associated with compensatory brain activity, too.

The harrowing conclusion from the study authors is that even young, healthy adults with type 1 diabetes “already have aberrant neural processing relative to their non-diabetic peers, employing compensatory responses to perform the task, and glucose management and duration may play a central role.”

What would be the findings among type 1s who keep their A1c in non-diabetic range, one might wonder? This study suggests it is likely that elevated blood sugar over time is what changes the brain activity. These effects are possibly compounded over time in those with comorbidities like obesity and high blood pressure.

What is Verbal Working Memory?

According to this study, verbal working memory processing may be affected by type 1 diabetes. Embury shared an example of this and wrote, “Participants had to memorize a grid of letters and were later asked to identify if a probe letter was in the previous set of letters shown.” She said we have to use working memory any time that we’re trying to hold on to or manipulate a piece of information for a short amount of time, like remembering a person’s phone number.

The verbal part of “verbal working memory processing” just has to do with the way that the information is presented, like letters or numbers and “anything that requires language processing as well” Embury explains.

More research will help clarify these findings in the future.

How to Use Average Blood Glucose to Estimate HbA1c


Checking blood glucose

By John Pemberton, Head Coach at Diabetic Muscle and Fitness and Diabetes Specialist Dietitian/Educator 

Do you have this essential diabetes management skill?

Most adults only get their HbA1c checked once a year, sound familiar?

This means you have an idea how things have been going for the previous 90 days, but what about the other 275 days?

The most effective way of keeping on top of your diabetes control is by regularly checking your average blood glucose (BG).

How Often Do You Check Yours?

Do you know how to use the results to predict HbA1c?

This table shows where your HbA1c will be very close to, depending on what level your average BG has been at for 90 days. The table also shows the benefits and consequences of having different levels of control for long periods of time.

What has your average BG been for the:

  • Last 90 days?
  • Last 30 days?
  • Last 14 days?

If you are currently in the red zone – don’t freak out!

This article is your wake up call. It’s time to take action. You can change this around very quickly, that is the beauty of using average BG to guide you.

How Do I Achieve Better Average Blood Glucose Levels?

Make small incremental changes to your daily diabetes habits and regimen. You can evaluate your progress by tracking the change in average BG every two weeks.

Top Diabetes Management Tips Based on 1000s of Hours Spent in Clinical Practice

  • Test BG at least five times per day – this allows you to correct high glucose levels more often.
  • Aim to be in target before bed; this means 8 hours per day of in target levels.
  • Bolus 15-30 minutes before food to prevent high glucose levels after, remember BIFF:
    • Blood test,
    • Insulin dose,
    • Fifteen minutes wait,
    • Food, eat it.
  • Keep to 3-4 meals per day, spread equally with 3-4 hours in-between.
  • This matches with the action of quick acting insulin (Apidra, NovoRpaid, Fiasp, Humalog) perfectly.
  • Frequent snacking makes in target glucose control very difficult.
  • Eat mixed macronutrient meals. Avoid carb only snacks, unless using for exercise management.
  • Review the patterns of your glucose trends every 14 days to identify where you need to change your habits and diabetes regimen.
  • Use a written log; there is a lot to be said for writing it down. Why? You process and identify patterns as you write.
  • Use an online platform where you can upload your meter, pump, and CGM devices:
    • Diasend & Glooko
    • They are both the same platform – they have just merged.

I personally use this platform and love it. I have even made guides and videos of how to set up an account, how to review control, and how to make changes in my day job as a Diabetes Specialist Dietitian. You can access these guides and videos here.

  • Use APPS such as MySugar and Diabetes:M
  • If you are struggling to identify solutions and find it hard to make changes, get professional help.

Your diabetes team or a professional with the requisite skills and qualifications should be able to guide and empower you.

If they just tell you what to do without teaching you how to do it, they are not setting you up for long-term success!

I work on the premise that as long as my average BG is less than 8.0 mmol/L (145mg/dL), I am all good.

If it’s above there, I need to focus on improving my control.

A special note: it’s no good having an average BG of 6.0 mmol/L (110mg/dL) if it means you are hypo all the time.

Research suggests having 3-4 mild hypos a week that you can treat yourself is usual for people with good control. But if more than this you are at risk of becoming hypo unaware. This research is from people on MDI and pumps who adjust their doses based on food intake and activity.

Being hypo unaware will mean you will not be able to drive (in the UK and most places if your physician knows or you call out an ambulance), and you will be at much higher risk of having a severe hypo. This is not a worthwhile trade-off for a HbA1c of 5.0%!

It’s all about balance.

Everyone is different, so set your target according to your circumstances.

As a general rule these are two good markers to aim for:

  1. Average BG less than 8.0 mmol/L (145 mg/dL).
  2. Less than 3-4 mild hypos per week, but no severe hypos and you can detect your hypos.

Checking average BG every 14 days will mean you stay in control and catch issues early! A Wiseman one told me: “If you’re not assessing, you’re guessing!”

Hope that helps!

References

  1. DAFNE Research Database Study

Disordered Eating with Diabetes


eating disorder with diabetes

 

“Are you hungry?” my husband asked me after a particularly difficult hike in the Rocky Mountains last summer that lasted over 12 hours, where all we ate during the day was trail mix and some dried fruit. He was starving.

“I’m fine,” I replied. “My blood sugar is 115.”

He looked at me quizzically, and lovingly reminded me that blood sugar and hunger are not the same thing.

As a person with diabetes, I have had to separate my hunger from my need of food. There have been countless instances when at dinner time my blood sugar was over 400, and I had to wait until insulin brought me down to a safe level before digging in. Conversely, there have been many times (too many to count) where I was not hungry at all, but of course had to eat something because my blood sugar was under 60. I am always cognizant of my blood sugar, but not always of the crucial hunger and fullness cues. This is problematic.

People with diabetes have a tricky relationship with food. Diabetes requires one to be diligent when it comes to tracking what and how much they eat. There is also constant monitoring of food intake (carbohydrates in particular), exercise, and insulin. Additionally, people with type 1 diabetes, whose beta cells have been destroyed by the body’s immune system, secrete none of the hormone called amylin at all. Amylin is a peptide hormone that is co-secreted with insulin, and inhibits glucagon secretion, delays gastric emptying, and acts as a satiety agent. This may be why some people with diabetes struggle to feel full after meals. As a result of all of this constant tracking of food, plus the inability to regulate our hunger cues, people with diabetes may be inherently more prone to issues around disordered eating.

According to the National Institutes of Health, adolescents (ages 12-21) with type 1 diabetes experience elevated rates of disordered eating behaviors in 37.9% of females and in 15.9% of males. For adolescents without diabetes, the rates are 3.8% and 1.5%, respectively. The most common type of disordered eating among people with type 1 diabetes is a little known condition called diabulimia, where people intentionally reduce their insulin intake to lose weight. This is a serious condition that leads to diabetic ketoacidosis (DKA) and even death, if not treated.

One in three teenagers (more often than not a girl) will face disordered eating in her lifetime with type 1 diabetes. We’re bombarded with magazines and ads, fad diets and “quick fixes.” We also have to maintain a healthy HbA1c, measure every portion of food we eat, and make sure we get adequate exercise and take our insulin appropriately. It’s stressful. And how “normal” is it that every 12 year old with diabetes knows the carb counts for not only every sandwich they eat, but all of the snacks they eat at sleepovers, as well as their birthday cake?

Holding all of that healthy knowledge inside is overwhelming, especially in a society that values thinness over all else. It is also powerful that every diabetic holds the keys to their health literally in their hands. If they mismanage their diabetes, they will lose weight (losing weight is also a classic symptom of diabetes, so it stands to reason that diabulimia and the mismanagement of the condition leads to weight loss). People with diabetes face many tough battles, and food is a major source of stress for most people with the condition.

Since many people’s relationship to food is warped, it’s important to note the symptoms of diabulimia if your loved ones are showing any of the following signs, and to seek help if you think they have a problem:

According to the National Eating Disorder Association, signs of diabulimia include:

  • Hemoglobin A1c level of 9.0 or higher on a continuous basis
  • Unexplained weight loss
  • Persistent thirst/frequent urination
  • Preoccupation with body image and a fear that insulin will cause weight gain
  • Blood sugar records that do not match hemoglobin A1c results (falsifying sugar logs)
  • Depression
  • Secrecy about blood sugars, shots, and eating
  • Repeated bladder and yeast infections
  • Low sodium/potassium
  • Increased appetite especially in sugary foods
  • Cancelled doctors’ appointments

If you think that you or someone you know is struggling with disordered eating or diabulimia, contact the diabulimia helpline or call their hotline, open 24 hours a day: (425) 985–3635.

Have you seen drastic dietary or behavioral changes in someone you love that has diabetes? Do you recognize any of the aforementioned symptoms in your own life? If so, please seek the help you need. Your diabetes and your life depend on it.

 

What Can Exercise Do for People With Type 1 Diabetes?


exercise and diabetesexercise and diabetes

In a meta-analysis done to look at exercise training in those with type 1 diabetes, researchers report which benefits were observed.

They sought to “establish the relationship between exercise training and clinical outcomes in people with type 1 diabetes.”

The study authors searched for prospective randomized or controlled trails involving exercise training in people with type 1 diabetes for 12 or more weeks though MEDLINE, Cochrane Controlled Trials Registry, CINAHL, SPORTDidscus, and Science Citation Index.

What Does Exercise Help With if You Have Type 1 Diabetes?

In those who exercised, researchers found that exercise lowered daily insulin needs, BMI (body mass index), peak VO2, resting heart rates, resting systolic blood pressure (the top number), LDL cholesterol, and triglycerides.

Children who exercised, specifically had lowered insulin doses, waist circumference, and triglycerides.

They didn’t find any effects from exercise on A1c levels however, nor fasting blood glucose, body mass, or HDL cholesterol levels.

What About  You?

If you have type 1 diabetes, what does exercise personally help you with? Share in the comments!

Exenatide via Osmotic Mini-Pump Improved A1c and Weight


ITCA 650 by Intarcia

 

ITCA 650 is exenatide in an osmotic mini-pump, a type 2 diabetes medication. It continually provides subcutaneous medication for 3 to 6 months.

Currently, exenatide is available as the brand name Byetta which is a liquid injection and also an extended release formulation marketed as Bydureon which comes in a powder that is mixed with liquid and then injected.

Researchers tested out ITCA 650 in two dose amounts and compared it to a placebo in patients with uncontrolled type 2 diabetes.

Over 39 weeks, this phase 3, double-blind, placebo-controlled trial randomized 460 patients between the ages of 18 and 80 who had an A1c level between 7.5 and 10 % (58-86 mmol/mol). So a third of participants took a placebo, another third ITCA 650 40 μg per day and another third took ITCA 650 60 μg per day.

The researchers looked for any A1c changes after those 39 weeks.

Does Exenatide Help Lower A1c Levels?

Taking ITCA 650 showed to lower A1c levels when compared to the placebo dose. The researchers wrote in their abstract that “In a prespecified analysis, greater HbA1creductions occurred in patients not receiving sulfonylureas (SUs) vs. those receiving SUs (−1.7% vs. −1.2% [−18.6 and −13.1 mmol/mol].”

They add that on week 39 37% of those taking ITCA 650 40 μg per day had an A1c below 7% (53 mmol/mol)–44% of those taking 60 μg per day lowered their A1c under 7% (53 mmol/mol) and only 9% of the placebo group lowered their A1c under 7% (53 mmol/mol).

ITCA 650 users also showed more weight loss than those on the placebo. The higher the dose of ITCA 650, the more weight lost.

As far as the most common adverse event, nausea was observed but also showed to go away with time. Of those taking ITCA, 7.2% stopped taking the medication because of gastrointestinal adverse effects while only 1.3% of patients stopped taking the placebo due to the same.

They concluded that “ITCA 650 significantly reduced HbA1c and weight compared with placebo and was well tolerated in patients with uncontrolled type 2 diabetes on oral antidiabetes medications.”

Wait, How Does an Osmotic Mini-Pump Work?

Intarcia Therapeutics is the company behind the osmotic mini-pump for ITCA 650. Their website states that their Medici Drug Delivery System is made so a trained healthcare provider can insert it in a patient during a regular in-office visit.

First it is placed under the skin and then “water from the extracellular fluid enters the pump device at one end – by diffusing through a semi-permeable membrane directly into an osmotic engine – that expands to drive a piston at a controlled rate.” This action lets the drug inside the pump release continuously at the other end of the pump. These osmotic mini-pumps are created to carry “an appropriate volume of drug over different dosing intervals,” states the company’s website.

The company is currently awaiting FDA approval.

Regarding the insertion of this device, the study authors state that the adverse effects “associated with procedures to place and remove ITCA 650 were mild and transient”.

Study Shows Keto Diet May Reverse Metabolic Syndrome


ketogenic diet

study tried to find out if a ketogenic diet could reverse the pathological processes that lead to metabolic syndrome.

Researchers looked to see if fasting triglycerides, BMI (body mass index), BFM (body fat mass), and weight could be lowered and to see if A1c levels could be lowered or normalized. They looked for increases in RMR (resting metabolic rate) and ketones.

They studied a group of 30 individuals who had been diagnosed by their primary care provider as having metabolic syndrome and randomly prescribed them one of three protocols. One group sustained a ketogenic diet with no exercise. The second group ate a standard American diet with no exercise and the third group was asked to eat a standard American diet but include 3-5 days of 30 minutes of exercise.

What is a Ketogenic Diet?

In the study paper, they explained that “Ketogenic diets are characterized by a reduction in carbohydrates (usually less than 50g/day) with a relative increase in the physiological proportion of dietary fat with adequate protein to feed individual lean body mass.”

They add that ketosis is an energy state the body uses when glucose availability is low whereby ketones are made by the liver. The researchers state that recently, evidence has shown that a ketogenic diet can help conditions like “diabetes, polycystic ovarian syndrome (PCOS), neurological degeneration, cancer, as well as marked improvement of respiratory and cardiovascular disease risk factors”.

Why Are These Results Notable?

The results showed that over the course of 10 weeks those who ate a ketogenic diet had reductions in weight, body fat percentage, BMI, and A1C levels.

The researchers wrote in their study paper that “All variables for the ketogenic group out-performed those of the exercise and non-exercise groups, with five of the seven demonstrating statistical significance.”

The two groups eating a standard American diet did not see any significant changes in any of the five main biomarkers for metabolic syndrome.

These findings are of interest because modern countries like the U.S. are enduring a growing epidemic of metabolic syndrome. Metabolic syndrome increases the likelihood of obesity, pre-diabetes, type 2 diabetes, and “numerous degenerative diseases”, write the researchers.

According to the study authors, based on their results–their statistical data, “the null hypothesis that a ketogenic diet has no effect on the five principle biomarkers of metabolic syndrome can be rejected.” These researchers say that “nutritional ketosis is a noteworthy modality of preventative and restorative care”.

They hope more studies can be done for the sake of developing a standard of care surrounding a ketogenic diet that results in a safe and effective practice.

ADA’s 2018 Standards of Medical Care Released


Standards of Medical Care in Diabetes 2018

Every year the American Diabetes Association (ADA) puts out an updated Standards of Medical Care approved by their board of directors which is their official position and provides all of their current clinical practice recommendations.

In this year’s Standards they state that “To update the Standards of Care, the ADA’s Professional Practice Committee (PPC) performs an extensive clinical diabetes literature search, supplemented with input from ADA staff and the medical community at large.” they update it each year or as needed online based on incoming evidence or regulatory changes.

It should be noted that most current Standards supersedes all previous ADA position statements.

Citing the way the field of diabetes moves quickly, the 2018 Standards of Care reveals the following major revisions:

Limits of A1c and Diagnostic Recommendations

Since recent evidence shows limits to A1c measurements because of hemoglobin variants among individuals, conditions that affect red blood cell turnover, and assay interference, recommendations have been “added to clarify the appropriate use of the A1C test generally and in the diagnosis of diabetes in these special cases,” states the ADA.

The ADA now recommends pre-diabetes and type 2 diabetes screening in children and teens who are overweight or obese and have one or more additional risk factors.

Comprehensive Medical Evaluation and Comorbidities

Components of a comprehensive medical evaluation now includes “information about the recommended frequency of the components of care at both initial and follow-up visits.”

The ADA added information about “the importance of language choice in patient-centered communication.”

They also now recommend healthcare providers consider checking serum testosterone levels in men with diabetes who have signs/symptoms of hypogonadism.

Dietary Clarification

The ADA stresses a clarification regarding nutrition: the ADA states that “there is no universal ideal macronutrient distribution and that eating plans should be individualized.” They have also included text to “address the role of low-carbohydrate diets in people with diabetes.”

low-carb diet for people with diabetes

On this point the Standards state, “The role of low-carbohydrate diets in patients with diabetes remains unclear,” They write that some of this confusion is due to different definitions of low-carb diets. “While benefits to low-carbohydrate diets have been described, improvements tend to be in the short term and, over time, these effects are not maintained,”

They concede that some studies show “modest benefits of low-carbohydrate or ketogenic diets” which entail under 50 grams of carbohydrate per day and say that ” this approach may only be appropriate for short-term implementation (up to 3–4 months) if desired by the patient, as there is little long-term research citing benefits or harm.”

The ADA does recommend children and adults with diabetes to reduce their intake of refined carbohydrates and added sugars and to get carbohydrates from vegetables, legumes, fruits, dairy, and whole gains. They write that the “consumption of sugar-sweetened beverages and processed “low-fat” or “nonfat” food products with high amounts of refined grains and added sugars is strongly discouraged,”

CGM Recommendation

Considering the latest data, the ADA now recommends the use of CGM (continuous glucose monitoring) in adults with type 1 diabetes to all adults ages 18 and up who are not meeting their glycemic targets (recommendation was previously for age 25 and up).

Drug Recommendations for Blood Sugar Treatment

Recommendations have been added due to data from the recent cardiovascular outcomes trial (CVOT) which shows that people with atherosclerotic cardiovascular disease should start with lifestyle management treatments plus metformin and “subsequently incorporate an agent proven to reduce major adverse cardiovascular events and/or cardiovascular mortality after considering drug-specific and patient factors.”

Managing Blood Pressure from Home

All patients with high blood pressure are now recommended to monitor their blood pressure at home to find out if they have “masked or white coat hypertension” and to help motivate patients to take their hypertension medication via awareness of elevated blood pressure.

Caution in Older Adults

New recommendations have been added to indicate how important individualized drug therapy is in older adults in order to lower the risk of low blood sugar episodes and to avoid over-treatment, as well as simplifying complicated regimens if at all possible while keeping the A1c target.

Pregnancy and Diabetes

A new recommendation emphasizes that insulin is “the preferred agent for the management of type 1 and type 2 diabetes in pregnancy.”

Citing new evidence, the ADA now recommends that pregnant women with type 1 and type 2 diabetes take a low-dose aspirin beginning at the end of the first trimester for the purpose of lowering the risk of developing preeclampsia.

Diabetes Care in Hospital

Insulin degludec (Tresiba) has been added to the insulin dosing for enteral/parenteral feedings.

For all the revisions visit the Summary of Revisions. For the pdf of the 2018 Standards of Care go here.

The Two Levels of Hyperglycemia and a Separate Definition for People With Diabetes


two stages of hyperglycemia

Steering Committee made up of representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange formed a decision-making group for the Type 1 DiabetesOutcomes Program.

Their goal was to develop a consensus on definitions for hypoglycemiahyperglycemia, time in range, DKA, and patient reported outcomes and while their decisions were informed via input from researchers, industry, and people with diabetes they relied on published evidence, their own clinical expertise, and Advisory Committee feedback.

We recently wrote about their definitions for hypoglycemia, here.

Level 1 Hyperglycemia

Level 1 hyperglycemia is defined by this group as a blood glucose concentration of >180 mg/dL (10.0 mmol/L) but ≤250 mg/dL (13.9 mmol/L).

The committee wrote that “In clinical practice, measures of hyperglycemia differ based on time of day (e.g., pre- vs. postmeal). This program, however, focused on defining outcomes for use in product development that are universally applicable.”

They believe that based on glucose profiles and post meal blood glucose data in those with no diabetes tell us that at or  over 140 mg/dL (7.8 mmol/L) is high blood sugar. However, since most people spend most of their day over that blood sugar level, they believe the guideline for measuring hyperglycemia should be different in those with diabetes.

Since the current guidelines for those with diabetes indicate that after meal blood sugar shouldn’t ever go over 180 mg/dL (10.0 mmol/L), the committee states that they would define high blood sugar starting at that point.

Changing Definitions to Keep Up With Patients?

It’s appropriate to clarify that this definition seems to be largely informed by the majority of patients with diabetes and not by what is deemed healthy in persons with no diabetes.

In other words, no matter what we call a blood sugar level of just under 180 mg/dL (10.0 mmol/L), the body will not discern between how hard it is to achieve a lower blood sugar and the damage that is known to be incurred through an elevated blood sugar.

The chronic and serious condition of type 2 diabetes is diagnosed with a fasting blood sugar of only 126 mg/dL (7 mmol/L) or higher on two separate tests, according to the Mayo Clinic. Some diabetes complications have been shown to occur with only slightly elevated blood sugar levels.

Is it a good idea to define high blood sugar differently for those with diabetes? Could this information be used by people with diabetes as a guide for their blood sugar goals? Would this be like the hypothetical example of telling an overweight person they’re not overweight if the definition of “overweight” has been changed due to a majority obese population?

Level 2 Hyperglycemia

Level 2 hyperglycemia is considered as “very elevated glucose as defined by a glucose concentration of >250 mg/dL (13.9 mmol/L).”

The committee states that over these levels, a patient’s risk for DKA is increased and the A1c levels associated with that glucose level are linked to a “high likelihood of complications”.

They write in their report that this definition “allows for the assessment of the ability of therapies and technologies to provide better glucose outcomes and to limit exposure to level 1 and level 2 hyperglycemic blood glucose values,” and that the definition is basically intended to apply to those with type 1 diabetes at any point of the day.

BG Levels

More Research Needed

The committee explains that we need more research in order to improve our understanding of how an individual high blood sugar vs sustained high blood sugar affects a person with diabetes over time.

They write that we could also use more research to improve our knowledge regarding to ties between high blood sugar and microvascular disease and other complications as well as ” the role of genetic factors and a patient’s ability to recognize when hyperglycemia is occurring”.

Automated Insulin Delivery (Artificial Pancreas, Closed Loop)


artifiical pancreas

 

The development of automated insulin delivery has many names – artificial pancreas, hybrid closed loop, Bionic Pancreas, predictive low glucose suspend – but all share the same goal: using continuous glucose monitors (CGMs) and smart algorithms that decide how much insulin to deliver via pump. The goal of these products is to reduce/eliminate hypoglycemia, improve time-in-range, and reduce hyperglycemia – especially overnight.

See below for an overview of the automated insulin delivery field, focused on companies working to get products approved. Do-it-yourself automated insulin delivery systems like OpenAPS and Loop are not included here, though they are currently available and used by a growing number of motivated, curious users.

We’ve also included helpful links to articles on specific product and research updates, as well as some key questions.

Who is Closing the Loop and How Fast Are They Moving?

Below we include a list of organizations working to bring automated insulin delivery products to market – this includes their most recently announced public plans for pivotal studies, FDA submissions, and commercial launch. The organizations are ordered from shortest to longest time to a pivotal study, though these are subject to change. This list excludes those without a commercial path to market (e.g., academic groups). The first table focuses on the US, with European-only systems listed in the second table.

Updated: November 4, 2017

US Products

Company / Organization Product Latest Timing in the US
Medtronic MiniMed 670G/Guardian Sensor 3 – hybrid closed loop that automates basal insulin delivery (still requires meal boluses) FDA-approved and currently launching this fall to ~35,000 Priority Access Program participants in the US. Pump shipments to non-Priority Access customers will start in October, with sensors and transmitters to ship by the end of 2017 or early 2018. Medtronic is experiencing a global CGM sensor shortage that won’t resolve until spring 2018.
Tandem t:slim X2 pump with built-in predictive low glucose suspend (PLGS) algorithm; Dexcom G5 CGM

t:slim X2 pump with built-in Hypoglycemia-Hyperglycemia Minimizer algorithm; Dexcom G6 CGM (including automatic correction boluses)

Launch expected in summer 2018. Pivotal trial now underway, with FDA submission expected in early 2018.

Launch expected in the first half of 2019. Pivotal trial to begin in the first half of 2018.

Insulet OmniPod Horizon: pod with built-in Bluetooth and embedded hybrid closed loop algorithm, Dash touchscreen handheld, and Dexcom G6 CGM

User will remain in closed loop even when Dash handheld is out of range

Launch by end of 2019 or early 2020, with a pivotal study in 2018
Bigfoot Biomedical Smartphone app, insulin pump (acquired from Asante), and a next-gen version of Abbott’s FreeStyle Libre CGM sensor (continuous communication)

The smartphone is expected to serve as the window to the system and complete user interface

Launch possible in 2020, with a pivotal trial expected in 2018
Beta Bionics Bionic Pancreas iLet device: dual chambered pump with built-in algorithm; hybrid or fully closed loop; insulin-only or insulin+glucagon; custom infusion set, Dexcom CGM

Likely to launch as insulin-only product, with glucagon to be optionally added later

Currently using Zealand’s pumpable glucagon analog

Insulin-only: possible US launch in the first half of 2020, with a pivotal trial to start in the beginning of 2019.

Insulin+glucagon (bihormonal) pivotal trial expected to start in the beginning of 2019. Timing of FDA submission and launch depend on a stable glucagon, among other things.

European Products

Company / Organization Product Latest Timing in Europe
Medtronic MiniMed 640G/Enlite Enhanced – predictive low glucose management

MiniMed 670G/Guardian Sensor 3 – hybrid closed loop that automates basal insulin delivery (still requires meal boluses)

Currently available in Europe

No timing recently shared. Approval was previously expected in summer 2017

Diabeloop Diabeloop algorithm running on a wireless handheld, Cellnovo patch pump, Dexcom CGM Pivotal trial expected to complete in February/March 2018. Possible European launch in 2018
Roche, Sensonics, TypeZero Will use Senseonics’ 180-day CGM sensor, Roche pump and TypeZero algorithm Pivotal trial expected to begin in Europe in early 2018
Cellnovo, TypeZero Cellnovo patch pump with integrated TypeZero algorithm; presumably a Dexcom CGM Aims for a 2018 European launch. No pivotal trial details shared

Helpful Links

Medtronic: MiniMed 670G

Tandem

Insulet

Bigfoot

Beta Bionics

Test Drives:

test drive – UVA’s Overnight Closed-Loop Makes for Great Dreams. Kelly participates in UVA’s overnight closed loop trial and reports back on an incredible opportunity for the field to move fast, reduce anxiety, and beat timelines.

test drive – Kelly and Adam take UVA’s DiAs artificial pancreas system home 24/7 for a three-month study. Their key takeaways, surprises, and next steps.

Key Questions for the Artificial Pancreas

Are patient expectations too high? If we expect too much out of first-generation artificial pancreas systems – e.g., “I don’t have to do anything to get a 6.5% A1c with no hypoglycemia” – we might be disappointed. Like any new product, early versions of the artificial pancreas are going to have their glitches and shortcomings. Undoubtedly, things will improve markedly over time as algorithms advance, devices get more accurate and smaller, insulin gets faster, infusion sets improve, and we all get more experience with automated insulin delivery. But it takes patience and persistence to weather the early generations to get to the truly breakthrough products. We would not have today’s small insulin pumps without the first backpack-sized insulin pump; we would not have today’s CGM without the Dexcom STS, Medtronic Gold, and GlucoWatch; we would not be walking around with smartphones were it not for the first brick-sized cellphones. Our research trial experience with automated insulin delivery recalibrated our expectations a bit – these systems are going to be an absolutely terrific advance for many patients, but they will not replace everything out of the gate. Let’s all remember that devices need to walk first, then run, and it’s okay if the first systems are more conservative from a safety perspective.

What fraction of patients will be willing to wear some type of automated insulin delivery system? Right now, many estimate that ~30% of US type 1’s wear a pump, and about 15% to 20% wear CGM. There are a lot of reasons why that may be the case, including cost, hassle, no perceived benefit, no desire to switch from current therapy, wearing a device on the body, alarm fatigue, etc. Will automated insulin delivery address enough of these challenges to expand the market?

Will healthcare providers embrace automated insulin delivery? Today, healthcare providers lose money when they prescribe pumps and CGM – they are very time consuming to train, prescribe, and obtain reimbursement for. We need to make sure that automated insulin delivery systems make providers’ lives easier, not more complicated.

Will there be a thriving commercial environment and reimbursement? It’s extremely expensive to develop and test closed-loop systems, and companies will only develop them if there is a commercial environment that supports a reasonable business. Reimbursement is a major part of that, and it’s hard to know if insurance companies will pay for closed-loop systems for a wide population of patients. We are optimistic that reimbursement will be there, especially if systems can simultaneously lower A1c, reduce hypoglycemia, and improve time-in-range.

What’s the right balance between automation and human manual input? The holy grail is a fully-automated, reactive closed loop that requires no meal or exercise input. But insulin needs to get faster to make that a reality. For now, daytime systems need to deal with balancing human input with automation, and there’s an associated patient learning curve. How much should automated insulin delivery systems ask patients to do? How do we ensure patients do not forget how to manage their diabetes (“de-skilling”) as systems grow in their automation abilities?

Insulin-only or insulin+glucagon? Ultimately, we believe that the question is partially one of patient preferences. There will be some patients who may want the extra glycemic control offered by the dual-hormone approach and will be willing to accept a bit more risk or a more aggressive algorithm. An insulin+glucagon system could be helpful for those with hypoglycemia unawareness, and if such a system makes it to the market, some patients will certainly want to give it a try. We believe a range of options is a good thing for people with diabetes, since all systems and products have pros and cons. Ultimately, cost considerations may present the largest factor in adoption. An insulin+glucagon system certainly brings multiple cost elements to consider – a second hormone, a dual-chambered pump, custom infusion sets, potentially higher training, etc. It’s hard to know at this point how the relative costs/benefits will exactly compare to insulin-only systems.