Author: Petr Čvančar

Petr Cvancar
Nexvax2 – promising vaccine to cure coeliac disease

Nexvax2 – promising vaccine to cure coeliac disease

The End of Gluten Free Diet?

Nexvax2 is promising vaccine to cure coeliac disease. It is currently the only vaccine in clinical trials with a high potential to actually cure coealiac disease (CD). To be clear it will cure the CD with a genotype form of haplotyte HLA-DQ2.5. About 80% – 90% of patients with coealiac disease have this genotype. To cure the CD thus means that patients become gluten tolerant again, without the need of any gluten free diet. This is really cool! The principle of the treatment is based on reprogramming T-Cells, the cells of the immune system, and their response to specific peptides of the gluten protein.

The very first phase of the clinical trial on a small scope of patients confirmed the positive effect and safety of the vaccine. Volunteers were vaccinated for a couple of months and then they could eat normally. The gluten free diet wasn’t followed. After a couple of months the effect was confirmed by the small intestine biopsy.

Thanks to the success of the first phase the clinical study continued to the second phase. The study in New Zealand is fittingly named Biscuit (Reset) Study. In this randomized phase of the study hundreds of volunteers in Australia, NZ and the US will be injected with placebo or vaccines twice a week for four months. Usually the second stage of clinical trials determines the medicine’s effect and safety using a larger sample of patients while lasting a couple of years. This will be followed by the third phase which will determine the medicine’s dosage. This phase could involve thousands of patients and is predicted to be the longest, 5 to 7 years. 

Uncertainty

A lot of progress has been made in the research of biological treatments of autoimmune diseases. So the question is not “will the CD be treatable” but “when will the treatment be available” and “how much will it cost”.

Web Resources

New Zealand clinical trial – Biscuit (Reset) Study

Clinical trial in the US – A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Pharmaceutical company ImmusanT

The vaccine that could end coeliac disease

The wheat is over: World’s first vaccine for people suffering with coeliac disease could end gluten-free diets

 

SENS Bars – Gluten Free – Lowcarb Highprotein Bar / Energy Bar

SENS Bars – Gluten Free – Lowcarb Highprotein Bar / Energy Bar

Since the beginning of my life with diabetes and coeliac disease, I’ve been looking for some healthy bars, tasty, filling snacks to eat that I will not force me to take a shot of an insulin bolus. That’s why the following parameters are based on my search for the ideal bars. I want bars from natural raw ingredients, without artificial additives, with a minimum of carbohydrates (as few as possible) and mainly without gluten. There are a lot of bars on the market made by different manufacturers, but all of those (at least the ones I found / tasted / saw) somehow did not meet my requirements. They either contain wheat, wheat pulp or milk protein, e.g. Myprotein Mybar ZERO made me feel as I were eating sticky dirt. Additionally, of course, they also contain lots of more or less artificial food additives, fully stiffened palm kernel grease, aromas, dyes, preservatives, etc. Given a choice I don’t want to eat any of that. But there is an alternative. These are the gluten free SENS Bars you can choose. Low-carb high protein bars and Energy bars.

SENS Bars
SENS Bars

I don’t fear BUGS I EAT them

Once I visited an e-shop while ordering my favorite gluten-free “Wholebake Flapjack”, which I use to fight with hypoglycemia, I encountered an unknown SENS Bar. I looked up the ingredients and immediately got interested. I like to experiment and try new alternatives. And because I’m open-minded, an unconventional ingredient could not stop me from trying it. What is the unconventional ingredient? Try guessing. Chirr, chirr – Acheta domesticus.

 

I started with a bar of dark chocolate with orange flavor and I must say that it totally captivated me. So I did not hesitate and ordered a test pack containing 4 different bars. Two low carb protein bars with “Dark Chocolate & Sesame” and “Peanut Butter & Cinnamon” flavors and two energy bars with “Dark Chocolate & Orange” and “Pineapple & Coconut” flavors. The base common ingredient of all bars is cricket flour. Other ingredients are fabulous things, such as dates, agave syrup, chocolate, cocoa, cashew nuts, peanut butter, sesame, coconuts, oranges or pineapples.

Gluten Free

Since I am a celiac, in addition, symptomatic and sensitive to a contamination, it is absolutely necessary for me to know if a food is glutened. So I asked the producer about how they feed crickets and if the bars contain gluten contamination. I received the following very satisfying answer: “We do not feed the crickets with gluten. There is no way for gluten to get into a bar, whether from cricket flour or any other ingredient. The bars are gluten-free and meet the strictest criteria. We passed laboratory tests and received a certification. If we fed crickets with gluten, there would be traces of gluten, but we do not do it, and therefore it is gluten-free. Besides, labeling “gluten free” is on the packaging of the bars and we could not do it if we did not have the certification. We take the safety of our customers and clear labeling of our bars very seriously.”

SENS Bar - nutrition information
SENS Bar – nutrition information

Try it, Taste it

I firmly believe there will be a lot of like-minded people who will come around to the SENS Bar. Whether it’s a diabetic looking for a low carb snack or a coeliac or a wheat allergic who cannot get gluten. Anyway, I personally recommend you to try the taste of these nutritionally valuable and healthy bars. Get over the years of insect eating prejudices and order a special sample pack of all four species on the manufacturer’s website. And if it helps you to make the decision, there is a negotiated unique 20% discount for coeliac, wheat allergic, and diabetic people. The discount code is “SENS4DIETERS” valid until 12/31/2020.

https://www.sensbar.com/en/product/sample-pack

SENS Bars - sample pack
SENS Bars – sample pack
Blood glucose meters comparison research

Blood glucose meters comparison research

To start with, there are certain indications that blood glucose meters (BGMs) constantly show systematic bias, which is typically evident in lower glucose level readings compared to laboratory values. I was inspired by Chris Hannemann’s independent research, where Chris provided a comparison of BGMs based on finger blood sample.

In contrast to the finger prick blood sample tests provided by Chris, this research goes much further to a more accurate level using standard BG laboratory tests. It is focused on the comparison between glucose meter reading and laboratory value using the same vein blood sample. The main goal is to find glucose meters on the market that are as accurate as possible, with the lowest bias compared to the laboratory value. The other goal is to prove the suspicion of the systematic bias in BGM readings.

The results will help the T1D and T2D (diabetes type 1 and type 2) community to manage the diabetes including the HbA1C targets. The knowledge of the systematic bias can be beneficial in order to understand how the specific BGMs measure the glucose level.

Initial status quo

  1. All the BGMs used in this research comply with the well known ISO norm 15197 no matter what release date is. Details about the ISO norm are not important in this research.
  2. The blood glucose laboratory analysis is the most accurate available method of measuring BG levels, so it was used as a baseline to compare vein blood sample with BG meters.

BGM set for testing

Before the research was performed members of Facebook diabetes groups were surveyed about the most used BGMs. As a result of that questionnaire the following set of BGMs was put together:

Full set of BG meters in the research
Full set of BG meters in the research
ManufacturerModel
AbbottFreeStyle InsuLinx
AbbottFreeStyle Libre
AbbottFreeStyle Optimum Neo
AscensiaContour Next ONE
BayerContour Plus
FORADiamond MINI Bluetooth DM30b
FORADiamond PRIMA DM10 Black
FORADiamond PRIMA DM10 White
LifeScanOneTouch Select Plus
LifeScanOneTouch Verio
RocheAccu-Chek Performa Nano
VPD2in1 Micro
WellionCalla Light
WellionCalla Mini

 

The Czech and the Slovak BGM distributors were kind enough to provide free samples of BGMs.

Test procedure

How the BGMs were tested?

The following procedure was set and accepted by a laboratory specialist.

  1. Blood sample was taken in a laboratory only when the CGM readings were stable (i.e. not rapidly decreasing or increasing).
  2. The reasonable representative set of glucose, from lows to highs, was taken to purposely reach different BG meters precision levels.
  3. The Blood samples were kept in specimen tube designated for preserving blood.
  4. A BG meter test was conducted during the hour after the blood was taken to avoid blood degradation.
  5. Test strips were taken from vials just before the test and inserted into the test slots to activate the BGMs.
  6. Blood was taken in with a syringe from a specimen tube and a blood drop was applied to the test strips.

 

1st test was made in laboratory
1st test was conducted in laboratory
Next test ware made at home
Next test was conducted at home

The testing was made possible with the help of the Czech laboratories SynLab and Aesculab.

http://www.synlab.cz
http://www.aeskulab.cz

Data collection

Test data was filled into Microsoft Excel sheet to record values like “Test ID, Test Date / Time, Blood Sample ID, Meter Model Meter, Serial Number, Test Strip Lot #, Test Strip Expiration Date, Result [mmol/L]”. There are 200 test records in total. Bias from Lab  [mmol/L] was calculated from laboratory and BG test measurements. The bias is the most important value in this research.

Screenshot of the data in Excel
Screenshot of the data in Excel

Analysis and results

The measurements were analyzed in Microsoft Excel using standard descriptive statistics.

The following chart is the main one showing the difference between BGM readings and laboratory measurement. The baseline is the laboratory value. The X-axis shows the test identification number (a blood sample) while the Y-axis shows the bias in mmol/L.

The main chart showing bias of BGM from laboratory
The main chart showing bias of BGM from laboratory

Next is the interpretation of the descriptive statistics measures.

 Data variability

From this standpoint of the data variability we can see that BGMs from manufacturers Foracare, Roche and VPD have the least deviation from the mean.

Data variability
Data variability

 

Similarly the range here confirms Fora Diamonds, Roche and VPD as the most acceptable BGMs for accurate readings.

Extreme values compared to the calculated range
Extreme values compared to the calculated range

 

Data accuracy

The variability of BG readings is very high for Contour Next One and Wellion’s. The most accurate from this standpoint are Fora Diamond’s and Roche Accu-Check.

Confidence Level
Confidence Level

Similarly to the confidence level even standard error confirms Fora Diamonds and Roche Accu-Chek as the most accurate BGMs.

Standard error of the mean
Standard error of the mean

Skewness, a measure of asymmetry, tells us here what BG readings presents in the normal, symetric distribution. Let’s assume Contour Next One, Fora Diamonds and Roche are the most precise BGMs from this measure standpoint.

Skewness of the data distribution
Skewness of the data distribution

 

Ambiguities in results

Wellion

It looks like the unprecedented peaks of the bias were caused by unstable enzymes in test strips. Test strips were used according to instructions but still it seems after opening the vial, enzymes degraded quickly.

Lifescan

Lifescan completely changed test strip technology some time ago. We can see very different systematic bias since then. OneTouch Select Plus uses older technology while Verio newer one.

VPD 2in1 Mini and Ascensia Contour Next One

Both these BGMs were obtained at the end of research, so the results are affected by lack of test samples. Lets consider it in final resolution.

Here are the champions!

Most of the quality indicators meet following BGMs.

  1. Fora Diamond Prima DM10
  2. Fora Diamond Mini DM30b
  3. Roche Accu-Chek Performa Nano

 

Photos of the winners

 

What to do next

To raise results onto a statistically significant level hundreds or thousands of tests must be done. One way to do this on larger scale project could be to distribute the work on volunteers all over the world and consolidate data into large database of BG measurements. If any of you are interested in joining, please send a message to “research at gandalf.cz”.

Conclusion

Why are there such differences between laboratory values and BG meters? One reason is definitely the technology used in BG meters/test strips. Second reason, and might be the most important, is the manufacturer – factory calibration. There were discussions with people from two different manufacturers. They claimed that the system bias is specifically set due possible law suites from people who were in hypoglycemic danger. Means that BG meters shows lower values for prophylactic reasons.

So even if the results are a bit affected by a small scale research, it is obvious that the original hypothesis about systematic bias was proven.

Disclaimer

Please consider this research was small scale. It was performed on personal basis so there were certainly budget and resource limits.

Contact author

In case you are interested in detail data feel free to contact author via email “research at gandalf.cz” or following contact form.

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