We invite people who have type 1 diabetes and whose insulin treatment is complicated by hypoglycaemia problems that have persisted despite best efforts at diabetes self-management. Those efforts will have included structured education in flexible insulin therapy (such as DAFNE, or BERTIE or the Joslin courses) and may have included trying insulin pump therapy or glucose sensing. The study will take place in King’s College Hospital and Guy’s and St Thomas’ Hospital in London; Sheffield Teaching Hospitals and the Royal Bournemouth General Hospital and we also have a centre in America at the Joslin Diabetes Clinic in Harvard. We expect approximately 96 patients will take part.

Our participants must be:

  • 18 years or older 

  • Type 1 diabetes for at least four years

  • Experiencing problematic hypoglycaemia for at least one year, despite structured education in flexible insulin therapy and on-going optimal conventional care*

  • Currently use appropriate (in the investigator’s estimation) multiple daily insulin injection regimen or CSII (insulin pump) therapy.

  • Willing to comply with study design, including willingness and ability to perform SMBG at least 4 times a day routinely

  • Able to communicate in written and spoken English

  • Able to give written informed consent.

Our exclusion criteria are:

  • People with type 2 diabetes, type 1 diabetes and good hypoglycaemia awareness

  • People with type 1 diabetes and impaired hypoglycaemia awareness who have not attended structured education in flexible intensive insulin therapy, such as DAFNE, BERTIE, the Joslin course or other as judged equivalent by the local investigator*

  • People not fluent in spoken English

  • Current pregnancy

  • People with severe mental disorders (schizophrenia,  depressive , manic depression, active suicidal ideation, learning disability,  alcohol and substance dependence, personality disorders, eating disorder)**

  • Cognitive impairment independent of hypoglycaemia (e.g. clinical diagnosis of dementia, advanced Parkinson’s disease, neurodegenerative disease)

  • Existence of co-morbid medical disease other than diabetes mellitus contributing to hypoglycaemia (e.g. inadequately treated Addison’s disease or growth hormone deficiency or hypothyroidism; untreated coeliac disease; uncontrolled gastroparesis; end stage renal disease).

*Having Gold and Clarke scores of 4 or more and having had ≥ 1 episodes of severe hypoglycaemia (needing treatment by someone else because of cognitively impairment to self-treat) in the last 2 years and at least one since starting current treatment modality. Structured education requires a programme with a curriculum, taught by trained educators, which covers insulin dose adjustment around carbohydrate counting and lifestyle issues, and a physiological 24 hr basal insulin replacement separate from meal insulin replacement

**This category covers people with severe and uncontrolled mental disorders such as those listed here. “Manic depression” covers conditions such as major depressive disorder and bi-polar disorder. Pre-existing depression that is on-going but, in the opinion of the investigator, stable and not a barrier to potential benefit from BGAT or HAPRdoc is not an exclusion criterion. Exclusion of individuals with a personality disorder includes those with current or previous clinical diagnosis AND current or previous mental health care for that disorder

Our eligibility criteria to take part in the HARPdoc study