Could there be 5 types of diabetes?

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Could there be 5 types of diabetes?

A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?

 

What is diabetes?

Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin.  Currently, diabetes is classified into two main forms, type 1 and type 2.

Type 1 diabetes is an autoimmune disease which manifests in childhood.  In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas.  As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.

Type 1 diabetes affects 10 percent of individuals with diabetes.  96 percent of children diagnosed with diabetes have type 1.  Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14.  The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).

Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced.  As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.

Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden.  The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014.  It is expected to rise to 592 million by 2035.  In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths.  43 percent of these deaths occurred before 70 years of age.  Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well.  In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).

In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.

 

The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study

This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.

This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications.  The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.

Cluster One – Severe autoimmune diabetes (SAID)

SAID is similar to type 1 diabetes.  SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA.  6% of individuals studied in the ANDIS study were identified with having SAID.

Cluster Two – Severe insulin-deficient diabetes (SIDD)

SIDD is similar to SAID, however, GADA is negative.  This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present.  Patients have a higher risk of diabetic retinopathy.  18% of subjects in the ANDIS study were identified with having SIDD.

Cluster Three – Severe insulin-resistant diabetes (SIRD)

SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI.  Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease.  15% of subjects in the ANDIS study were identified as having SIRD.

Cluster Four – Mild obesity-related diabetes (MOD)

MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal.  22% of subjects in the ANDIS study were identified as having MOD.

Cluster Five – Mild age-related diabetes (MARD)

MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters.  Patients with MARD have mild problems with glucose regulation, similar to MOD.  39% of subjects in the ANDIS study were identified with having MARD.

This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels.  This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).

The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.

Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes.  For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.

 

References

Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].

Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].

Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].

Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].

NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].

The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].

World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.

If you are a clinician, dietitian or laboratory who are interested in running diabetes assays, Randox offer a wide range of high-quality routine and niche assays including: fructosamine, glucose, HbA1c for diagnosing and monitoring diabetes, albumin, beta-2 microglobulin, creatinine, cystatin c, NEFA, microalbumin, and d-3-hydroxybutyrate to monitor associated complications, and adiponectin  as a biomarker for diabetes risk assessment.  These assays can be run on most automated biochemistry analysers.

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.

For more information, visit: https://www.randox.com/diabetes-reagents or email: reagents@randox.com 


Diabetes – World Diabetes Day (14th Nov 2017)

World Diabetes Day

With World Diabetes Day on Tuesday 14th November 2017, we take a look at what diabetes is and why quality control is so important.

What is Diabetes?

Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.

Type 1 Diabetes

Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.

Type 2 Diabetes

A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.

Role of Quality Control

Quality control plays a crucial role in ensuring accurate and reliable diabetes monitoring. 70% of medical decisions are based on a laboratory test result and QC is vital in ensuring the results the laboratory report are both accurate and reliable.

Want to know what makes a good HbA1c control? Read on to find out.

Clinically Relevant Levels

In the diagnosis of diabetes, glycated haemoglobin (HbA1c) in blood provides an indication of average blood glucose levels in the previous three months. HbA1c is the recommended standard of care for type 2 diabetes monitoring. HbA1c is measured using the range below:

HbA1c – Clinically Relevant Levels
HbA1cmmol/mol%
NormalBelow 42 mmol/molBelow 6.0%
Prediabetes42 to 47 mmol/mol6.0% to 6.4%
Diabetes48 mmol/mol or over6.5% or over

It is important to assess the full clinical range of an assay, i.e. the range between the lowest and highest results which can be reliably reported. 48 mmol/mol is the cut-off for diabetes diagnosis, it is crucial that this can be measured accurately because any inaccuracy could mean the difference between being diagnosed and treated and not.

In terms of accreditation, ISO 15189:2012 states, ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.

Benefits of Third Party Controls

The importance of third party controls is evident. Third party controls can help identify instrument, reagent, and procedural errors. Unchecked these errors could lead to incorrect patient results, further leading to misdiagnosis.

Third party quality control material has not been designed or optimised for use with any instrument, kit, or method. This complete independence enables the quality control material to closely mirror the performance of patient samples, and in doing so, provide an unbiased, independent assessment of analytical performance across multiple platforms.

Again, in terms of accreditation, ISO 15189 states – “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”

Many laboratories perform HbA1c testing on a dedicated machine and as a result, are not always using a third party control.

Controlling Waste

Wastage is a common issue when running HbA1c due to the pre-treatment step required for many HbA1c controls and poor stability of some controls on the market. Look out for controls with an extended open vial stability to help reduce waste and keep costs low.

How can Randox help?

To help you get your QC in check for World Diabetes Day, Randox Acusera HbA1c control contains both HbA1c and Total Haemoglobin, with a reconstituted stability of 4 weeks to reduce waste and reduce costs. To find out more about our HbA1c control visit the page using the button below or fill out the form above.

World Diabetes Day

References

Diabetes: The basics. (2017). Diabetes UK. Retrieved 3 November 2017, from https://www.diabetes.org.uk/diabetes-the-basics

Khan, H et al. (2016). Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights, 95. http://dx.doi.org/10.4137/bmi.s38440


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