Less awake than I thought or why coffee matters.

I had an early flight Tuesday. Out of Baltimore because there was a direct flight and I would rather spend an extra hour in the car than a layover and extra time in the air. Not that I mind the air part.

By early I mean get up before 4:00 am. I’m a bit of an insomniac so that works out to just a few (2) hours of sleep. No worries, I thought, I can do this.

I got up showered, brushed my teeth and thought I need to grab my tooth brush. I kept my bag zipped open to remind me. So I dropped it in and zipped it up. 

I stopped for coffee and an extra shot of expresso to get into driving mode. Nice easy run down I-95. Simple quick Southwest flight. 

I freshened up for the memorial service and thought I should brush my teeth, ya'know for the coffee breath,  and found this in my bag:

No tooth brush. 

That extra shot of expresso may have been a far wiser choice than I initially thought. 

FDA Approval Summary Dexcom G4

Old news but possibly an interesting reference, the FDA's Approval and Clearance page for the Dexcom G4:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm323661.htm?source=govdelivery

Vizzini's View of Diabetes Data Standards

One of the earliest YDMV posts stated out my view on diabetes data:

Type 1 isn’t all about the numbers. It is about kids living their lives. That said there are one hell of a lot of numbers. We gotta deal with the numbers, so we can love the kids as kids. Nobody need love the numbers. 

There are a ton of little electronic machines that produce billions and billions of numbers (and about as many strips on the floor). At times it seems we are floundering in a sea of data points (and strips on the floor). Unfortunately each machine speaks its own language. What we need is the UN. United Numbers.

It seems that I am not the part of the diabetes universe that sees data standards as a problem.  I recently read two articles that make the case for researchers to have a common diabetes data set. Data Standards in Diabetes Patient Registries (Journal of Diabetes Science and Technology May 2011) and A Strategy of Defining Common Data Elements to Support Clinical Care and Secondary Use in Clinical Research, (AMIA Clinical Research Informatics Summit 2010) both make the case that research would be better off with standards to facilitate data that researches, “collect once, use many times.”

As I understand the issue, research reinvents the diabetes data wheel with virtually every study. Each study collects what they are interested in but since it is not a common data set few studies have data that can be combined and used to further additional investigation.

One paper even has this lovely little graphic that helps demonstrate the overlap of parties that could benefit from common data. 

The second paper goes on to talk about these stakeholders in detail:

“There were no defined data standards for primary or secondary use in T1D at the start of this project, and so it is likely that the elements we have compiled will be subject to debate and revision when vetted in a broader T1D stakeholder community, which should include perspectives from diabetes care, research, population monitoring, and quality measurement.”

Notice anybody missing from that? 

I did. 

People with Diabetes.


It is their data.

In short if researchers want people to share their health information, there should be a value for participating. The ethical term is beneficence, that the research does some good for the participants.

I think that for diabetes research to find solutions that improve the lives of people living with diabetes those researchers need to ask the right questions. Starting with: Who is a stakeholder? As the risk of sounding like Vizzini, it seems inconceivable to effectively improve patient outcomes without seeing people with diabetes as a stakeholder in the process. 

http://www.youtube.com/watch?v=D58LpHBnvsI

Closed Loop = Better BG Control in Kids

Diabetes Care reports a study of closed loop (AP but I think I like the term closed loop better because an actual pancreas does more.)  This study shows kids do better, particularly over night. Sadly I don't have access to the full paper but here is the reader headline and conclusion form the abstract. 

Closed-Loop Insulin Therapy Improves Glycemic Control in Children Aged <7 span="span" years="years"> 

Closed-loop insulin delivery decreases the severity of overnight hyperglycemia without increasing the incidence of hypoglycemia. The therapy is better able to reestablish target glucose levels in advance of a subsequent meal. Younger children with type 1 diabetes may reap significant benefits from closed-loop therapy

http://care.diabetesjournals.org/content/early/2012/09/26/dc12-1079

Little Help? Spouses and Significant Others of Adult T1Ds

From the Behavioral Diabetes Institute: 

Just For PartnersDevelopment of an Online Program to Address Emotional Distress in the Spouses and Partners of Adults with Type 1 Diabetes

Help Needed!

WHO WE ARE: A joint project of the Behavioral Diabetes Institute (which is run by William H. Polonsky, PHD, CDE) and the Bringing Science Home initiative (directed by Nicole Johnson).

GOAL: We know that sometimes it can be tough and frustrating when you have a partner with type 1 diabetes.  So we are developing the first Web-based program that is designed to help you, the spouse or partner of an adult with type 1 diabetes, to cope more successfully.  In early 2013, this program will be available to partners all over the world at no cost.    

WHAT WE NEED: In this first phase, we are looking for partners/spouses of adults with type 1 diabetes to complete an online questionnaire.  We will use the initial results of this questionnaire to help us understand how partners are struggling and what might be needed to help them.  We will then use these findings to build the tools for the final online program.  

Please note that we will not be asking you for any personal information that will identify you in any way.   The questionnaire is completely anonymous.

WHO IS ELIGIBLE: Anyone who has an adult spouse or partner with type 1 diabetes.  Must be fluent in English.

WHAT WE WANT YOU TO DO: If you are willing to participate, please access our private and secure study website at: http://justforpartners.behavioraldiabetes.org.  The questionnaire will take approximately 15 – 20 minutes to complete. 

WILL THERE BE COMPENSATION: Well, no.  Sorry about that.  But you will have the pleasure of knowing you have helped us move this important project forward and that you will be contributing to a project to help other spouses and partners deal more effectively with type 1 diabetes!

Pennsylvanians, Please Act for Kids with Diabetes in School

 Hello my fellow Pennsylvanians. I know that sounds like the opening to a  political stump speech.

I hope this is more of a response to one.

Now is the time write our elected officials. Once again legislation is pending that would allow schools, parents and adult volunteers in schools to help kids with diabetes. Specifically in the administration of diabetes medications, insulin and glucagon. Yes in PA we need this law because as it stands now it is not legal for a school nurse to delegate giving glucagon.

ADA has a super easy fill in the form and customize letter generating process that we can use to share with our legislators.
Click here: https://donations.diabetes.org/site/Advocacy?cmd=display&page=UserAction&id=2378

Put in some details about your family and why safe at school matters.

Maybe if we act now our ligislators will too. 

"Don’t Freak Out Over a (T2) Diabetes Diagnosis"

The latest installment of the “Taking Control of Your Diabetes” series is online.

http://myuctv.tv/2012/10/08/dont-freak-out-over-a-diabetes-diagnosis

Dexcom G4 Approved in USA aka Dexcom Platinum

From the press release today:

October 8, 2012
U.S. FDA Approves the Dexcom G4™ PLATINUM Continuous Glucose Monitor (CGM)

New Device for Diabetes Management is Most-Advanced CGM Available with up to 30% Improvement in Hypoglycemic AccuracySAN DIEGO--(BUSINESS WIRE)-- Dexcom (NASDAQ: DXCM), a leader in continuous glucose monitoring, announced today that the U.S. Food and Drug Administration has approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.
Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

Fulll press release:
http://investor.shareholder.com/dexcom/releases.cfm

CGM, Pregnancy, A1C and What are the Right Questions.

Just read this short write up of a CGM and pregnancy study: http://www.obgynnews.com/news/top-news/single-article/continuous-glucose-monitoring-offers-no-pregnancy-benefit/5699b76dcc1c8cbf0d16e9d4160a94bc.html I'll call the study Secher after the good doctor who did the study. 

It seems to me Secher et al studied intermittent use of a CGM because they thought getting full time compliance would be hard. They found that intermittent, what they more or less defined as non compliant, use was not a benefit. Another earlier study by Murphy, et al found the opposite: http://www.bmj.com/highwire/filestream/384096/field_highwire_article_pdf/0/bmj.a1680

I would love to see more detail but it seems the Secher study may be asking the wrong asking the question. It asks does partial CGM help not does CGM help. Is this normal research? - to only look at intermittent use that the designs see as a surrogate of non compliant use? What happen with more compliant use and dose that use lead to less total glycemic variability.

A statement in the article attributed to Secure's says, "By focusing on severe hypoglycemia, we might pay a price in hyperglycemic complications. " This seems to indicate that they were not focused on balanced control of BG but more hypo avoidance. The study is not reported out yet so one can not  know for sure. If so then, the complication of hyperglycemia were not addressed as highs weren't the focus. This seems to be the case as a write up of the study states that s secondary outcome of this study was, "Metabolic control in terms of HbA1c, blood sugar measurements and the occurrence of severe hypoglycemia in pregnant diabetic patients." (http://clinicaltrials.gov/ct2/show/NCT00994357) To me, and I am no expert, that suggests they were focused on lows not highs. However it is the highs, in the third trimester, that may be the issue.

The Murphy paper says, "Prepregnancy care is key to improved glycaemic control during the first two trimesters but does not reduce the risk of macrosomia, which we believe is more strongly associated with hyperglycemia in later gestation.12 Data from the Netherlands suggest that near optimal glycaemic control during early pregnancy (84% of women had a mean HbA1c level of 7.0% or less) failed to reduce the risk of macrosomia, present in 48.8% infants.1 This prompted us to consider new strategies, focusing on reducing postprandial hyperglycaemic spikes during the second and third trimesters. Observational data suggest a strong correlation between maternal postprandial glucose levels in the third trimester with an increased risk of macrosomia.13-17 Educational approaches incorporating additional glucose testing after meals to improve glycaemic control in late gestation have shown potential to reduce birth weight.18 19 " So it seems to me the issue isn't the device but how the moms to be are coached and supported to learn and manage BG with the CDM device. Still this second paper reports out A1Cs.

I would love to see these studies talk about variability, maybe measured as standard deviation, particularly in the third trimester, in addition to A1C. CGM is a tool to report and so facilitate management to minimize variability in ways finger stick can not. I would love a study that looks at the question - can women be coached and supported to manage glycemic variability with a CGM in ways that reduce third term hypers and hypos that has an impact on birth weights? Is this variability management more predictive of healthy birth weight than A1C? 

That seems to me to be closer to the right questions or is it just me?





ps. It was really hard for me not to make jokes here. Sadly I would think that if Secher is used to deny CGM insurance coverage as an option to help coach women in pregnancy it would be a case of Murphy's law not Murphy's study. 

Monday on 'Rents: Mark Fox

Mark Fox

Monday Oct 8, 9:00 pm eastern

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