Smart Insulin Pens are here… finally.

The first “smart” insulin pen has finally hit the market. This is a big moment for diabetes care, as the digital toolbox expands. (I wrote a post in 2013 about this topic, asking for someone to make a smart insulin pen)

From the perspective of a person with diabetes, this has the potential to solve many daily challenges. First, did I remember to take my insulin dose? Or, did I recently take a dose and forget that I did, leaving me at risk for hypoglycemia if I inject now? Another key  question for a PWD is, how much “insulin on board” do I have (that is, how much of my recently injected insulin is still affecting me)? Of course, another key element is the ability to track and capture insulin doses and not have to write them down in a logbook for your doctor!

From the provider perspective, we gain a huge amount of data to help us help our patients make decisions and learn from their experiences. For years, if we wanted to review a glucose and insulin time series, we either needed a patient to write down numbers in a logbook or to put someone on an insulin pump. More recently, manually entering data into an app became an option. The “smart” insulin pen finally means that glucose and insulin data can relatively easily (and passively) be captured into one place. This can help guide care in real-time as well as for retrospective review and analysis.

For the many people with type 1 diabetes who do not want an insulin pump, and for the people with type 2 diabetes for whom a pump is not covered or necessary, these smart insulin pens are likely to offer real benefits.

The next ask?

An automated way to capture food intake!

 

Other sources:

DiabetesMine DData 2017 has some slideshows on smart insulin pens

 

The Surgeon’s Viewpoint: Swedish Obese Subjects Study and Bariatric Surgery

The Swedish Obese Subjects study is a fabulous example of how very-useful practical knowledge can come out of a well-conducted cohort study.  Not everything has to be a prospective randomized controlled trial!   This study has produced a number of landmark papers which provide convincing evidence that:

1.       Bariatric surgery offers survival benefit over the long term for the morbidly obese, despite the up-front mortality risk from the surgery itself.

2.       Bariatric surgery reduces cardiovascular and cancer deaths

3.       Bariatric surgery is durable: most patients do not regain the weight back

4.       Not all bariatric procedures are the same.  Some work better than others.

5.       Diets, behavioral modification, and “professional” weight loss coaching doesn’t really work for the morbidly obese in the long haul.

6.       And now….bariatric surgery prevents onset of diabetes!

The strength of the Swedish Obese Subjects trial is in the follow-up.  Since Sweden has a nationalized health care system, follow-up was completed on >95% of the initial cohort.  Such a trial could never be conducted in the United States….our people change jobs, towns, or insurances just way too often!

And there is just one more thing you should know about the Swedish Obese Subjects trial: the vast majority of the surgery cohort underwent vertical banded gastroplasty (VBG).  What’s that, you ask?  It was a first-generation bariatric operation that has been abandoned worldwide in favor of better (i.e. more effective) operations, such as gastric bypass and sleeve gastrectomy.  So if this trial were repeated in 2012, we would expect even better results in the surgical arm with fewer complications.

So where does that leave us?  For any patient with BMI > 40 (or BMI >35 with metabolic disease), you should really get them thinking about surgery as an option.  It’s not just about weight, and certainly has nothing to do with cosmetic appearance.  It’s about getting serious about treating metabolic disease: diabetes, hypertension, sleep apnea, hypercholesterolemia, PCOS, and others.  It’s about making sure that those diseases never develop in the first place.  It’s about reducing overall cancer risk, stroke risk, and heart attack risk.  And it’s about improving overall quality and quantity of life.

So why, then, with such powerful clinical evidence, do less than 1% of adults who would benefit from bariatric surgery actually get it?  That, my friend, is complicated, and probably worth another blog in its own right!

Jonathan Carter, MD

 

3 Thoughts About The V-Go Insulin Delivery Device

I had a chance this week to spend some hands-on time learning about the new V-Go insulin delivery device from Valeritas.  Valeritas’ website states that “The V-Go is engineered to simplify basalbolus insulin therapy for the millions of people suffering from Type 2 diabetes.”

      

The facts:

– This is the first disposable insulin-delivery device that will give basal-bolus insulin.

– It is mechanical, containing no electronics.

– It is designed to be worn for 24 hours before it needs to be refilled with insulin.

– The needle is a 30 gauge needle that stays in the user while the V-Go is in use.

– The V-Go comes in 3 “sizes”: one that delivers 20 units of basal insulin over 24 hours, one that delivers 30 units, and one that delivers 40 units.  Each device is also capable of giving bolus insulin in 2 unit increments up to 36 total units of bolus insulin per 24 hour period.

Three thoughts about the V-Go:

1) Convenient: This device appears well-built and relatively easy to use.  It is about the size of an Omnipod, and because it is placed on the user for 24 hours straight, allows her to leave insulin at home when going out for the day.  The device needs to be refilled every 24 hours with rapid-acting insulin.  So, the user need only take fingerstick/testing supplies out with her when going to work, running errands, or going out to meals.  It is also somewhat elegant that there are no electronics in the device.

2) Not enough insulin for some patients: Though this device promises convenience, the amount of insulin that can be delivered is too little for some people with type 2 diabetes.  The most that can be delivered is 40 units of basal insulin and 12 units of bolus insulin per meal (totaling 36 units of bolus insulin a day).

3) Inability to titrate: The device comes in 3 sizes, each delivering a set basal amount of insulin over 24 hours.  These are either 20, 30, or 40 units.  While this may be useful for a patient who has already been on a steady dose of basal insulin, it does not give much flexibility to titrate doses.  Once a patient has paid her co-pay at the pharmacy and picked up a month’s supply, she would have to pay again to switch to a different basal rate.

I think this device represents an interesting start towards a market that will likely increase rapidly in the next few years of devices intended to deliver insulin to people with type 2 diabetes.  Given the above limitations, I think it’s overall usefulness will prove limited, but I look forward to seeing what future iterations and generations of devices will look like.

What do you think?  Would you want to try this (either patients with type 2 diabetes or providers caring for patients with type 2 diabetes)?

Is bariatric surgery really going to be the new standard for type 2 diabetes?

There has been a lot of publicity lately over the two articles released as online firsts this week in the New England Journal of Medicine.  Both of these articles were single-center, randomized-controlled trials comparing bariatric surgery to intensive medical therapy in patients with type 2 diabetes.  One trial was done at the Cleveland Clinic (link here) and another done in Italy (link here).  Here is the NY Times article covering the story.

Italian study (Mingrone G et al.: Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. NEJM 2012 Jan. 2)

This study took 60 patients with BMI more than 35, type 2 diabetes for more than 5 years, and hemoglobin A1c of >7% and split them into three groups.  One group received gastric bypass, one group biliopancreatic diversion, and one group medical therapy.  The primary end point was the “difference in the rate of remission of type 2 diabetes among patients undergoing either gastric bypass or biliopancreatic diversion, as compared with medical therapy.”  They defined remission of diabetes as a fasting glucose of <100 mg/dl and an A1c of <6.5% for at least 1 year without active pharmacologic therapy.

One notable thing about this study was that the average BMI across all three groups was 45.  The average A1c going into the study was 8.5%.

As you can see above, the A1c reduction in the two surgery groups was significantly better than the medical therapy group.  In fact, every secondary end-point (other than blood pressure) was significantly improved with surgery rather than medical therapy.  This includes cholesterol, weight, and waist circumference, among other end-points.  In terms of the primary end-point, 0/20 patients achieved remission with medical therapy, compared to 15/20 with gastric bypass and 19/20 with biliopancreatic diversion.  One thing I noticed is that the A1c curve above for gastric bypass starts to rise from 12 to 24 months and one wonders whether given another couple of years whether it might come closer to the medical therapy A1c curve.

Cleveland Clinic study (Schauer PR et al.: Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. NEJM 2012 Jan. 2)

This was a larger trial than the one done in Italy, with 150 total patients instead of 60 total patients.  Also notable is that the average BMI was 36, much smaller than the average BMI of 45 in the Italian study.  The stated goal of medical management in this trial was “modification of diabetes medications until the patient reached the therapeutic goal of a glycated hemoglobin level of 6% or less or became intolerant to the medical treatment.”  The two surgeries performed in this trial were gastric bypass and sleeve gastrectomy.  The primary end-point was the proportion of patients with an HbA1c of 6% or less with or without diabetes medications a year after randomization.  In this trial, the average HbA1c at trial start was 9%.

The medical group had a reduction in A1c to 7.5%, the surgical groups to about 6.5% (with statistical significance).  Again, secondary end points like body weight and lipids were also significantly reduced in the surgical groups.  This trial also demonstrated a dramatic decrease in the number of diabetes medications required in the surgical groups compared to the medical treatment group.  I find that to be a useful outcome measure, since it is actually something that “means something” to patients.  Not having to take medications anymore is a really big deal and a nice lifestyle change for lots of patients.

My take on these studies:

Are these studies going to change my practice?  Probably not dramatically.  I’ve already been practicing under the assumption that bariatric surgery is an excellent way of causing weight loss and “curing” a number of comorbid illnesses like diabetes.  These trials give us a higher level of evidence to back that belief up than we’ve had before.  So, on balance, maybe I’ll be a bit more likely to recommend that a patient consider bariatric surgery.

If I have beef with these studies, it is that in both of these studies, diabetes was treated as a categorical variable rather than a continuous one.  The real significance of the diagnosis of diabetes is your risk for long-term complications such as nephropathy, retinopathy, and cardiovascular disease.  However, there is no “magic number” hemoglobin A1c at which these complications are either guaranteed to occur or not occur.  So, while “remission of diabetes” is a sexy term, in some ways it can be a hollow term, as it assumes that crossing the threshold from an HbA1c of 6.6% to 6.4% is going to make a real difference.

Also, we should not forget the short term risks of surgery compared to medical treatment.  I’m not going to try to get into any statistical analyses, but there are real risks to these surgical procedures.  In the Italian study, 10 out of 38 surgical patients had “late complications,” meaning things like incisional hernia, low albumin, osteoporosis, or iron-deficiency anemia.  In the Cleveland Clinic study, 15/99 (15%) surgical patients compared to 4/43 (9%) of medical treatment patients had “serious adverse events requiring hospitalization.”  Thus, with each patient considering one of these surgeries, we must weigh these risks against the benefits of the surgery.  Is it better to take on these risks and aim for remission of diabetes?  Or are you well-enough off going with medical therapy and avoiding the potential surgical risks?  Somewhat remarkably, the intensive medical treatment groups saw their A1c drop around 1.5% in both of these trials, a none-too-shabby outcome.  From my vantage point medical treatment versus surgery is an individualized decision that should be shared between patient and physician.

This is a rich subject matter and there is much more that could be said about these two papers.  However, I generally try to be brief on this blog, so I’ll end here.  Please share your thoughts.