Background and Aims

Continuous glucose monitoring (CGM) is increasingly used by in diabetes therapy and is partly replacing self-monitoring of blood glucose (SMBG). However, CGM and SMBG measure glucose in different compartments which are known to exhibit a time lag in glucose concentration. In addition, CGM systems use different calibration procedures and algorithms to calculate glucose values. Studies showed that there can be considerable systematic measurement differences between CGM systems.

Methods

While for SMBG systems an international standard describing test procedures and accuracy criteria is available, there is no international standard for CGM systems established. In addition, CGM glucose values currently cannot be traced to higher order materials or methods because a reference measurement in s.c. tissue is currently not feasible. The major metric, the mean absolute relative deviation (MARD), that is used to describe CGM accuracy, is highly dependent on many factors like study design and therefore only offers limited comparability between systems.

Results

The IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) recently founded a new CGM working group. Objectives are the establishment of traceability for CGM glucose values, definition of procedures for assessment of the analytical performance of CGM system and definition of suitable metrics and acceptance criteria regarding analytical performance.

Conclusions

Considering the increasing importance of CGM in diabetes therapy, standards addressing traceability, testing procedures and acceptance criteria are needed.

Background and Aims / Part 1

The first decade of continuous glucose monitoring (CGM) was relatively slow due to challenges with accuracy, burden, and cost. However, as we are now about half-way through our second decade of CGM with much higher usage, it is fair to ask the question and speculate who will be using SMBG five years from now?

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Methods / Part 2

In the United States, in late 2017 Medicare, the payer for the elderly and disabled, started CGM coverage for individuals receiving multiple injections of insulin. The Medicare approval occurred shortly after the Freestyle Libre and Dexcom G5 launch, and thus this improved technology could be widely by those who previously couldn’t afford it. By late 2019 our type 1 population in our academic clinic was well over 70% CGM use. Our type 2 population, with over 80% using insulin, is over 25% CGM use (and no SMBG use)

Results / Part 3

However, our clinic is not the rule either in the US or elsewhere. We still have many payers in the US who will not pay for CGM and in fact are stingy with SMBG coverage. Worldwide the increase of diabetes is outpacing what we can afford. In the recent “IDF Atlas” it is predicted that in Africa there will be a 143% increase in diabetes prevalence. Currently in low-income countries there are approximately 60 million adults with diabetes where even obtaining insulin is a struggle. In these countries, it is not realistic to think CGM will become standard when currently SMBG is often difficult to obtain.

Conclusions / Part 4

SMBG is not going away in the next 5 years, or for that matter the next 10 years. For most people in the world, expense is the primary reason CGM can’t be a reality and SMBG, even occasional, will be the only way to monitor diabetes.

Background and Aims / Part 1

Medical products used by patients with diabetes are increasingly used as they make treatment more safe and officious; however, all the light comes along with the shadow of trash production.

Methods / Part 2

As such products are produced and used millions of times each day, the plastic material used for the products themselves and the packaging adds up to a huge amount of plastic waste.

Results / Part 3

Patients are well aware of this and start to complain about this. We see the need for acknowledging this issue and a change in our approach. A better balance between performance of the products and their environmental impact has to be found; however, diabetes technology and trash is a complex story with many different aspects.

Conclusions / Part 4

A better balance between performance of the products and their environmental impact has to be found; however, diabetes technology and trash is a complex story with many different aspects.