ABCD Testosterone & Diabetes Worldwide Audit
ABCD worldwide audit of testosterone deficiency in men with type 2 diabetes
There is a high prevalence (~40%) of Testosterone Deficiency in men with Type 2 Diabetes. Testosterone Deficiency is now recognised as a common co-morbid condition associated with type 2 diabetes. The ADA Standards of Medical Care in Diabetes 2021 (Recommendation 4.11) states that ‘In men with diabetes who have symptoms or signs of hypogonadism such as decreased sexual desire (libido) or activity, or erectile dysfunction, consider screening with a morning serum testosterone level’. Male hypogonadism is defined as a clinical syndrome which must include symptoms with or without signs and biochemical evidence of testosterone deficiency. National and International Guidelines are available which provide an evidence based to the management of testosterone deficiency in men. The management of hypogonadism requires a careful diagnosis and replacement of testosterone if indicated back to a consistently normal circulating testosterone level at least in the mid-normal healthy range.
The primary indication for testosterone therapy in men with diagnosed hypogonadism is sexual dysfunction. Clinical trials have demonstrated that symptoms of sexual function can improve with testosterone replacement therapy. Studies also suggest that there may be benefits on physical and psychological function as well. Clinical trials have reported that testosterone therapy reduces insulin resistance, body weight, waist circumference and some publications suggest there is an improvement in HbA1c, lipid profile, reduction in hepatic fat. A recent registry study has been published which demonstrates a gradual improvement in these parameters over several years with some patients entering remission of their diabetes. Epidemiological studies have found that testosterone deficiency is associated with a greater than two-fold increase in all-cause and cardiovascular mortality in men with type 2 diabetes as well as other populations. Reports also suggest that testosterone replacement in type 2 diabetes has a beneficial effect on survival. A recent large 2-year study has reported that testosterone therapy with pre-diabetes and low testosterone reduces the proportion of men developing type 2 diabetes over and above lifestyle changes.
Purpose of Audit
This audit sets out to help individual clinicians and to determine from several centres the clinical effects and monitoring of testosterone replacement therapy in men with type 2 diabetes and hypogonadism in real world clinical practise in the short and longer-term. Data can also be collected from men with hypogonadism where the decision by the patient or clinician is not to treat.
Monitoring is essential to be sure there is a clinical improvement, adequate replacement and to detect any adverse events. The haematocrit and PSA should be assessed at baseline, 3,6 and 12 months and yearly thereafter. Secondary polycythaemia can be managed in the majority of cases (see guidelines). There is no evidence that testosterone replacement causes the development of a new prostate carcinoma but may after initiation unmask a mall unidentified occult cancer a few months after initiation of treatment. The audit has a number of objectives.
Downloadable files that you might find helpful
Rationale for Audit Form
Helpful clinical tips and suggestions
Links to clinical guidelines on management of testosterone deficiency
AMS evaluation form
AMS questionnaire
Non ABCD members
Non ABCD members are welcome to take part in the audit and will be given access to the on-line audit tool when they register for the audit.
Analyse your own data
The tool will allow you to analyse the data of your own patients for your own local interest; at the same time the data will automatically be available for national analysis of anonymised data. Some videos showing ways of analysing your own data are available through the ABCD YouTube channel and some useful links to the videos can be found here.
Acknowledgement of contributors
As we have done with previous audits all contributors will be acknowledged in all papers and presentations from the audit data and biggest contributors will be offered the possibility of being co-authors.
Collect data on-line or via paper forms
The Testosterone and Diabetes on-line audit tool is so easy to use that live data entry in clinic is a real option to be considered. Otherwise to facilitate data collection during clinics there are two paper forms which exactly match the data that can be entered into the audit tool. You can download and print these forms locally.
Audit Objectives
To see the audit objectives as they were when the audit was launched click here
Further information
Further enquiries may be made to the ABCD nationwide audits database administrator of the project.
Papers, abstracts, presentations, posters and webcasts emanating from the audit
Click here to see the output from the audit as it evolves. The names of all the contributors will be found in the presentation slides and in the published papers.