Table 1

Inclusion and exclusion criteria

Inclusion criteria
Participants willbe aged ≥18 years.
have had T1DM for  at least 4 years.defined clinically, having started insulin therapy within a year of diagnosis and/or having a history of diabetic ketoacidosis).
have been experiencing problematic hypoglycaemia for at least one yearImpaired awareness of hypoglycaemia
Gold and/or Clarke score of ≥4. 46 47
having had >1 episode of SH, with at least one since starting the current treatment modality and having had more than one episodes of SH.episodes requiring assistance of another person to actively administer carbohydrates, glucagon or take other corrective action, because of impaired cognitive function and which may include episodes that were not treated by another but included loss of consciousness or seizure. 2
be willing to comply with the study design, including performance of glucose self-monitoring at least four times a day.
be able to communicate in written and spoken English and give written informed consent.
Exclusion criteria
People with
type 2 diabetes, or T1DM and intact hypoglycaemia awareness.
no previous attendance at a structured education programme.such as DAFNE, BERTIE, DO-IT or the equivalent as judged by the investigator.
lack of fluency in spoken English.
current pregnancy.Participants who continue to experience SH episodes 6 months after they have stopped breast feeding may be included.
severe mental disorders.schizophrenia, manic depression, depressive psychosis, active suicidal ideation, learning disability, dementia (either an existing diagnosis or a Mini-Mental State Examinations score of less than 24), alcohol and substance dependence, personality disorders); cognitive impairment independent of hypoglycaemia;
comorbidities other than diabetes contributing to hypoglycaemia risk.(eg, inadequately treated Addison’s disease or growth hormone deficiency or hypothyroidism; untreated coeliac disease; uncontrolled gastroparesis; end-stage renal disease), which must have been checked since the onset of problematic hypoglycaemia.
a diagnosis of eating disorder.
  • DAFNE, Dose Adjustment for Normal Eating; SH, severe hypoglycaemia; T1DM, type 1 diabetes mellitus.