A1C Level Down Dramatically to 6.4

My first A1C test after implementing the Abbott FreeStyle Navigator II CGM showed a modest improvement: from 7.1 percent to 6.8 percent. As I get to know/rely on the device and learn to make better bolus correction decisions, I am now able to take a more aggressive approach. This has resulted in my best A1C test result ever: 6.4 percent! This translates into an average BG over the last three months of 137 mg/dl, not too shabby…

See here for a table showing A1C-Average BG conversions: http://www.mayoclinic.com/health/a1c-test/MY00142/DSECTION=results

Abbott FreeStyle Navigator 2.0 Continuous Glucose Monitor Product Review

Abbot Diabetes Care FreeStyle Navigator II Continuous Glucose Monitoring System Product Review

The overdue successor to Abbott’s first generation FreeStyle CGM, the Abbott Diabetes Care FreeStyle Navigator II delivers on all fronts: accurate sensor, smaller transmitter, longer range and flexible reports. Now if only they’d improve the sensor adhesive…

Me & My FreeStyle Navigator 2.0

To the dismay of many satisfied users in the U.S., the original FreeStyle Navigator (Nav) was permanently discontinued by Abbott Diabetes Care (ADC) in 2011 following an unexplained “supply interruption.” Since then, ADC continued to supply this device – and an upgraded 1.5 version – throughout Europe and the Middle East.

In April 2013, ADC performed a soft launch of the redesigned FreeStyle Navigator II (Nav2), introducing it on a limited basis to customers in the UK, Germany, Scandinavia, Holland & Israel. I was fortunate to be one of the first to give it a go.

Receiver Display
Let me be perfectly blunt: the Nav2 receiver display is nothing like a modern-day smartphone with an HD screen. Rather it’s more like a Blackberry of yesteryear with an 8-bit color display that you will be hard-pressed to read in anything more than moderate sunlight.  For retro Blackberry fans there’s a scroll wheel and two softkeys.

 

 

 

 

 

 

 

 

FreeStyle Navigator 2.0 Homescreen

The display homescreen shows the current BG reading, BG trend arrow and four-hour graph.

• Current Glucose Level
  Current BG is prominently displayed on the home screen and is updated once every minute. Depending on whether the measurement is in or out of the customizable target range (mine is 80-180 mg/dL), the result appears as follows:

215 = above range (Purple)

125 = within range (Green)

65 = below range (Yellow)

• Trend Arrow
  → BG steady
  ↗ BG rising moderately (60-120 mg/dL per hour)
  ↑  BG rising rapidly (more than 120 mg/dL per hour)
  ↘ BG falling moderately (60-120 mg/dL per hour)
  ↓ BG falling rapidly (more than 120 mg/dL per hour)

Abbott markets this as TRU™ Directional Arrows that are updated with each CGM reading every minute. The idea is to tell you if glucose levels are changing gradually, moderately, or rapidly. This works reasonably well and assists in trying to master the fine art of correction bolus.

• Graph
  The homescreen graph shows the last four hours of BG levels; a more detailed history is accessible via the Reports sub-menu. Glucometer tests appear with a + sign.
•  Sensor/Insertion

Nav2 Sensor Mount (AA battery & credit card)

Nav2 Sensor Inserter

The Nav2 sensor mount and transmitter are significantly (40%) smaller than in the original Nav, with the sensor measuring glucose in the interstitial fluid 5mm under the skin. ADC authorizes use of the sensor either in the abdomen or on the back of the upper arm. I have also worn the sensor on the back of my upper and lower waist with no performance degradation.

Sensor insertion is mostly pain-free and harmless, certainly in comparison to my Medtronic infusion set inserter which is like harpooning a whale! After disconnecting the inserter, you slide the transmitter into the sensor mount until it “clicks.” Unfortunately, the ADC mechanical engineers have failed here because there isn’t really a clear/firm click and you’re left wondering if the transmitter is indeed connected properly.

Nav2 Sensor & Transmitter Affixed

My #1 problem with the sensor is the adhesive performance, or lack thereof. The first few months I was shedding sensors early and often within a couple of days. I attribute this to a double whammy: insertion only into the back of the upper arm (because of minimal fatty tissue in my stomach and a lot of core rotation in my exercise regimen) coupled with the fact that I play a lot of tennis in a hot/humid climate.

Working with the local ADC agent – Geffen Medical – we were able to resolve this using a couple of after-market products: pre-swiping the target site with a 3M Convacare barrier wipe, and post-insertion application of Smith & Nephew Opsite Flexifix transparent film strips. Notwithstanding, it would be much easier if Abbott found a stickier, water-resistant adhesive for their sensor mount.

I also had a problem with a couple of faulty sensor inserters that didn’t release the sensor into the skin. This is a known issue that ADC is working to resolve and one that didn’t occur with the previous generation FSN inserters.

Sensors are three-digit coded, and come in boxes of six for one month of usage. Although not promoted by Abbott, it is possible to detach and then re-affix the transmitter to reset/extend sensor life; however, because of my adhesion issues I was only able to do this on one occasion.

Calibration & Accuracy
You only fly blind for one hour with the Nav2. Glucose results are provided immediately after performing the first calibration so long as the calibration BG level is in the 60-400 mg/dL range.

Five calibrations – using the built-in FreeStyle (Lite) glucometer with code-free test strips – must be performed over the five-day sensor lifetime. With four calibrations in day one, you get four days with only one calibration. For me this was a major selling point: only one fingertip prick in four days. Also, BG levels are updated each and every minute, giving users the most up-to-date BG data.

 

 

 

 

 

 

 

 

 

Built-in FreeStyle Lite Glucometer

Occasionally, after the second calibration in particular,  the system may prompt you to perform an additional test (after 15 minutes, 1 hour or 3 hours) if the BG level is unstable – rapidly rising or falling during calibration testing. A shortcut workaround for this is to perform a manual BG calibration test (or two) before the requested wait time.

Calibration	How Long After Starting Sensor	Grace Period
1	1 hour	None
2	2 hours	30 minutes
3	10 hours	2 hours
4	24 hours	8 hours
5	72 hours	8 hours

I have found the Nav2 CGM readings to be quite accurate, typically within 10% of the FreeStyle glucometer results. I have done some random testis to compare, and can say non-scientifically that I am very happy with the system’s accuracy.

One minor complaint on the built-in glucometer: while they included the bright test strip port light of the FreeStyle, it’s defaulted off, requiring an annoying button press to light up.

Connectivity & Battery Life
The Nav2 receiver is fitted with a standard mini-USB port that for PC connectivity, charging and device data download using the FreeStyle CoPilot software; a dedicated A/C wall charger is also provided. The display timeout is programmable from 15-120 seconds – to extend battery life I have set mine to the minimum 15 seconds. This is more than enough for the quick BG check, and I am now getting over seven days between charges (ADC states a battery life of three days under typical use and a full charge time of six hours).

The transmitter battery life is quoted at one year, after which the transmitter must be replaced, i.e. one-year consumable. There is a Status sub-menu that shows the receiver and transmitter status as a percentage; after five months my transmitter status is 75%.

This system uses the FreeStyle CoPilot Health Management software, and I give it a thumbs down as it’s available only for PC, not Mac. Really, it’s not a great software suite, I must say.

Events & Alarms
You can create a history of your daily activities using pre-defined events, including Insulin (type and units), Food (breakfast, lunch, dinner, snack), Exercise (aerobics, walking, jogging, running, swimming, biking, weights, other) and State of Health (Normal, Cold, Sore Throat, Infection, Tired, Stress, Fever, Flu, Allergy, Period, Dizzy, Feel Low, Feel High). You can add eight custom events; unfortunately you cannot define a custom event descriptor.

Programmable alarms include: Low Glucose, High Glucose, Projected Low, Projected High, Data Loss and System. Each alarm type includes a programmable tone and/or vibrate option as well as a snooze time. Different values can be programmed for Day and Night.

1. Low Glucose Threshold – range is 60-119 mg/dL
2. High Glucose Threshold – range is 120-300 mg/dL
3. Projected Low – advance notification of 10/20/30 minutes when approaching the Low Glucose threshold.
4. Projected High – advance notification of 10/20/30 minutes when approaching the High Glucose threshold.
5. Data Loss – indicates glucose results are no longer available. Reasons for this include:

• Expired sensor (clicking the scroll wheel shows when the sensor will expire)
• Overdue calibration
• Sensor not working correctly
• Transmitter disconnected from the receiver

Unsurprisingly, I have gotten acquainted with each of these alarm types, in particular the Projected Low that has saved me from many a hypo.  The Data Loss alarm caused by transmitter disconnect frequently occurs immediately after insertion of a new sensor. When first pairing the transmitter with the receiver after connecting a new sensor, I found that performing the Connect to Sensor function a couple of times seems to keep it connected going forward.

Other disconnects occurred when I was out of range in my duplex apartment with reinforced concrete. The stated range is 30m/100ft line-of-sight, similar to what I witnessed, and long enough to cover me on the tennis court.

Reports
The history and reporting are quite flexible and easy to use. For a graphical representation, from the Home screen you press the Graph softkey and then use the scroll wheel to go back as far as you want in 4-hour increments.

To dig deep into the numbers, from the Reports menu you get a complete CGM history in 10/20/120 minute increments, CGM statistics including one-day average/high/low, as well as percentage of time spent at/above/below the Target range. There are also separate detailed BG test history and Events reports.

Carry Case

The Nav2 comes with three colored skins: purple, pink and black. Although they protect the receiver from the occasional drop, they are not convenient when it comes to carrying it. I prefer to use the zippered case that Abbott provided with the original Nav: not only does it offer some protection, but it also has a belt clip for wearing on-person as opposed to in-pocket with the skin. Although not a perfectly snug fit, it does leave room for some cash and cards.

FreeStyle Navigator 2.0 Skins

Original FreeStyle Navigator Case

Conclusion

Despite a few quirks and idiosyncrasies, the Abbott FreeStyle Navigator II has really improved my T1D quality of life. CGM accuracy is high and the minute-by-minute BG updates are a godsend for this amateur athlete. Sensor life may be shorter than with Dexcom G4 or Medtronic Enlite, but having four days with only one fingertip test is a treat.

Pricing is different by country, and luckily I have no out-of-pocket expenses in Israel. But I have seen Abbott’s UK pricing: $1,500 for the FreeStyle Navigator 2.0 receiver and transmitter, and $600 for a month’s supply of sensors.

Abbott has always been a leader with the FreeStyle glucose measurement technology, and the Nav2 doesn’t disappoint – built-in FreeStyle glucometer, extended transmission range, flexible graphical & numerical reports, programmable alarms – the FreeStyle Navigator 2.0 has it all. My wife Meirav and I both love it, now they just need to make it stick to the skin!

Freestylin’ in Israel with the Abbott FreeStyle Navigator II CGM

Freestylin’ in Israel with the Abbott FreeStyle Navigator II CGM

Check out my guest review of the latest continuous glucose monitor from Abbott Diabetes Care: the FreeStyle Navigator II (2.0) CGM, published on Diabetes Mine.

How Do You Make Your CGM Sensor Stick?

The biggest challenge I’ve had with my Abbott FreeStyle Navigator 2.0 CGM is keeping the sensor stuck to my skin. At first I didn’t use anything, relying on the default adhesive used by Abbott, but this didn’t work too well, as I was shedding sensors like a lizard sheds its skin. he combination of a hot/humid climate and lots of tennis was lethal for the on-board adhesive So I moved to after-market products and here’s what I’ve tried so far:

Then someone recommended that after attaching the sensor, I affix it some strips of Hyporplast , a 100% polyester, white adhesive used for medical devices.This looks very much like the default adhesive used by Medtronic in their Quick-set^® infusion sets which very rarely detach.  While Hyporplast works great when in-built on my infusion sets, it was not getting the job done as an add-on to my FreeStyle II CGM sensor.  I had to replace the strips daily, the polyester material was not so comfortable on my skin, and it felt a little thick for me.

The next referral was for ConvaTek AllKare protective barrier wipes, a non-water soluble barrier film layer on the skin. After cleaning the insertion area with an alcohol swab and letting it dry, I rub the wipe on the skin, effectively creating a very sticky fly trap. Then I attach the sensor mount adhesive to the wiped area. This made things far better, but I still wasn’t always able to get the full five days out of my sensor before it was falling off. My search continued.

Next up was another adhesive, this time a spray: Hollister Medical Adhesive, a silicone spray that is not supposed to be affected by water.  This adhesive is so strong that it is highly recommended for prosthetic devices! I found this spray to work as advertised. Unfortunately, even though I do not have particularly sensitive skin, my skin reacted unfavorably to the spray and I broke out in a nasty rash.

Last but certainly not least, a nurse at my endo’s office hooked me up with some clear film strips which turned out to be Smith & Nephew Opsite Flexifix.  Flexifix is a transparent & waterproof acrylic adhesive that solved my problems. It is very thin – around 2.5mm – which is just a little more than a layer of skin!

After experimenting with various combinations, I have found the winning recipe for me: I begin by prepping the skin with ConvaTel AllKare; apply the sensor to the barrier wiped area; and then reinforce it with four strips of Flexifix.

Please let me know what works for you!

Insulin OD: How I Got Insurance to Cover My CGM

Here’s a guest feature for A Sweet Life describing self-induced hypos in order to get a fully reimbursed CGM in Israel: 
http://asweetlife.org/feature/insulin-overdose-how-i-got-insurance-to-cover-my-cgm/

 

 

 

 

Homeopathic Statin Alternatives to Improve Cholesterol Levels

Back in 2004 when my endo in Denver first prescribed me a statin, my HDL (“good” cholesterol)  was 38 and my LDL (“bad” cholesterol) was close to 200. I had taken some dietary measures to improve these results, but with limited success. ALT, AST and triglycerides were all in check.

After 18 months on the statin, the cholesterol improvement was dramatic: my HDL had climbed to 64 and LDL plummeted to 95. Unfortunately, out of the clear blue sky my blood work showed elevated ALT and AST levels: 78 u/L and 85 u/L respectively! I had heard about this statin side effect, one that could lead to liver problems and/or damage. In consultation with my family doctor, I immediately stopped taking the statin and combed the web looking for alternative (homeopathic) treatments. I also made an appointment with my long-lost, oft-ignored dietitian to get her recommendations.

I immediately began taking Red Yeast Rice and Phytosterol supplements, and switched my breakfast regimen to include oatmeal with soy milk, banana and a variety of nuts: almonds, Brazilian nuts, walnuts and Macadamia nuts  (three or four each). I also made a better effort to reduce the high-fat/yellow cheeses that I so adored. I continued with my Mediterranean diet, including lots of olive oil, daily avocado, fish/salmon twice a week, lots of fresh vegetables and limited red meat intake. I was already exercising 5x a week so there wasn’t much I could do there. Within three months, my ALT and AST results returned to their normal, pre-statin levels: 10-15 u/L, though my LDL had crept back up to 140 and HDL dropped to 40.

I was happy that I was off the meds, but I was still not happy with my cholesterol numbers. So I took another step: added 1 Tbsp. of oat bran to my morning routine and switched to rye bread. This gave me another improvement, lowering my LDL to 120 and raising my HDL to 56. I know that the ADA, AHA and most everyone recommend an LDL below 100,  but I am nonetheless quite happy to be where I am under the circumstances.

I would be glad to hear your recommendations on additional steps you’ve take to reduce LDL and increase HDL…

I’m back…

Yes, it’s been a long four months of home improvement, but the end result is worth it. For any of you who have done a home improvement, you know what I’m talking about. And with a renovation in Israel , the pain and suffering is magnified ten-fold. 

Lots of interesting content coming up so stay tuned…

FreeStyle Navigator II: One Week Later

So it’s now been a week that I’ve been using the Abbott Diabetes Care FreeStyle Navigator II CGM, and I’m thoroughly enjoying the device. Since currently there is little English-language information available on the Web, I have begun the arduous process of writing a full product review for the benefit of my fellow T1DM patients.

Too excited about FS2 – no time to shave!

If you have any questions about the FreeStyle II CGM system in the meanwhile, please feel free and contact me …

How Do I Qualify for CGM Reimbursement in Israel?

Although there is much critique of the drawbacks of “socialized medicine,” the socialized health care system in the State of Israel his on the cutting edge of diabetes technology reimbursement. Virtually any diabetic who needs and/or wants an insulin pump can get one from his/her HMO, as they are included in the basket of services offered to all citizens. Getting a CGM device, however, is a bit more complicated, especially if you are an adult male.

In 2010, the Israeli Ministry of Health took a big step forward, including CGM’s for any diabetic up to the age of 18. The following year, pregnant women – or women trying/planning to get pregnant – also became eligible. In 2012, adult males over the age of 18 suffering from “hypoglycemia unawareness” were added to the mix. Though there were high hopes that the eligibility floodgates would open to all in 2013, in the end no changes were made to the service basket with regards to CGM’s.

So how does the Israeli Ministry of Health define hypoglycemia unawareness? Basically, you need to arrive at a hospital emergency room – or be taken to the hospital in an ambulance – with a blood sugar level below 50 mg/dl. If such an event occurs twice in the course of a 12-month period, then you become automatically eligible for a fully subsidized CGM from your HMO.

Once you have your CGM – currently the Abbott Labs FreeStyle Navigator II and the Medtronic Enlite systems are available, though the models may differ depending on the HMO – the consumables are also covered. Each HMO has its own out-of-pocket ceiling for those with chronic diseases/illnesses; my HMO Maccabi, for example has a monthly ceiling of NIS 256 (~$70) or semi-annual limit of NIS 1,024 (~$280).

The one-time cost of a FreeStyle II from the Israeli Abbott Labs agent Geffen Medical without HMO reimbursement in Israel cost less than $2,000, while the monthly consumables would set you back NIS 2,500 ($670).

Here’s a great overview of the Israeli healthcare system from Michael Aviad, founder of the ASweetLife.org online diabetes journal.

Abbott Labs FreeStyle Navigator (1.5) CGM Product Review

Here’s a quick take of the Abbott Labs FreeStyle Navigator 1.5 version after four days of trial use:

The Good

1. Sensor and its interstitial plasma cell readings initially seems to be quite accurate. This thing can actually distinguish between all of the sugars, salts, fatty acids, amino acids, coenzymes, hormones, neurotransmitters, and waste that is in these cells.
2. Sensor insertion was pain-free, and I didn’t really feel it under my skin.
3. As a very active exerciser and experimental foodie, the ability to get an accurate reading each and every minutes is absolutely AMAZING & LIBERATING!
4. I can fully program and customize alarms for low/high/rising/dropping blood glucose levels. On the Navigator II you will be able to select a unique audible notification for each event.
5. After three calibrations in day one, it was great to know that I would only have to do a traditional blood glucose test twice over the course of the next four days. The main reason that I chose the Abbott Labs Freestyle Navigator II over the Medtronic Enlite is the fact that the Enlite needs to be calibrated 2-3 times daily, and then the blood sugar levels from my FreeStyle Lite glucometer manually entered into the Paradigm Veo pump.
6. My wife Meirav loved it too. I found her looking at the readings early and often. Those who have suffered from hypoglycemia themselves, or those whose loved ones have insulin reactions, know that people with low blood sugar often behave like jerks, easy to annoy or to be annoyed by. I would use hypoglycemia as an excuse when behaving improperly or inappropriately, which in fact was often the case. But now that blanket excuse is no longer, Same goes for my tennis matches when I am ineffective and playing lousy. My glucose levels can now be found out with a glance at the screen! This will also help avoid the lethargy associated with elevated glucose levels.

The Bad (Less Good)

1. The transmitter on the FreeStyle Navigator 1.5 is rather large and cumbersome for the stomach and upper arm locations approved for use. I am looking forward to the 2.0 version, which is about half the size.
2. Transmission range on the Navigator 1.5 is only 3m/10ft. This simply wasn’t enough for me. And the reconnection was not always automatic, often requiring a manual reconnection taking 70 seconds. The Navigator II offers an extended transmission range of 30m/100ft, and automatic reconnection if you go out of range. When playing tennis, the new version will allow me to leave the receiver on the bench as opposed to in my pocket for real-time updates.
3. On day two, while in the shower, the transmitter disengaged itself and fell on the ground. Granted, there is good water pressure in our jetted shower, but I was surprised that it would disconnect so easily. The sales associate told me that in five years of use her transmitter had only fallen off once, while in a jacuzzi, but my sample fell off twice in four days (see #5 below).
4. On my third day of use the sensor had a panic attack and lost its accuracy. I got numerous low glucose alarms which were not accurate based on how I felt – Navigator CGM indicated sugar levels of around 50mg/dl while the FreeStyle Lite test strips confirmed my feeling, showing levels in the 90-100mg/dl range. After talking to the 24/7 customer service rep and doing some calibration blood tests, the sensor suddenly returned to life and resumed its accurate readings.
5. On day four, while with my wife doing what people do in the bedroom when not sleeping or watching TV, the transmitter fell off again. When I went to reconnect the transmitter after we finished what we were doing, the interstitial sensor had disappeared, Thus my brief trial of the FreeStyle Navigator 1.5 screeched to a premature (self-degrading sexual pun intended) halt .

Since this week I will be receiving the spanking brand new FreeStyle Navigator II, I will focus my upcoming product review efforts on the new version.