What are the alternatives for treatment?
Participation in the trial does not alter your diabetes treatment. You will continue to take your usual insulins and do your usual glucose monitoring. You should be testing your blood at least four times a day – before each meal and at bedtime and you should continue to adjust your doses as you usually would. Changes in your insulin regimen may be made as in usual practice, in discussion between you and your diabetes health care team. We will record any changes made at each study visit.
Assuming you have tried everything available to you to reduce your hypoglycaemia risk already, we have no other alternatives to offer. Neither of the treatments in this trial are currently offered as standard practice in the UK. We need to do the trial in order to establish how well each treatment works – both have been shown to reduce severe hypoglycaemia, HARPdoc in a very small pilot study of 24 people and BGAT in several formal trials in the US and Europe – BGAT however has not yet been tested in people who have already completed a structured education course in flexible intensive insulin therapy. As such courses also reduce severe hypoglycaemia risk, this study will tell us how much more BGAT can do.
You are being asked to participate in this trial because you have continued to experience severe hypoglycaemia despite having attended a structured education programme in flexible insulin self-management (such as DAFNE or BERTIE) which do minimise bad hypoglycaemia experience. If you have not yet tried them, insulin pump therapy and/or glucose sensing can help reduce severe hypoglycaemia although they do not work for everyone and they do not seem to restore natural protection from severe hypoglycaemia – ie. awareness of hypoglycaemia. The only other treatment currently available would therefore be either islet or pancreas transplantation.