CompletedNot Applicable

Hypoglycaemia Awareness Restoration Programme

United States, United Kingdom99 participantsStarted 2017-03-09

Plain-language summary

Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe hypoglycaemia reduced when people are taught how to adjust their insulin around their life-styles through structured education but problematic hypoglycaemia may persist. Many people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit from conventional treatments to reduce hypoglycaemia. The investigators developed the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that combines revision of knowledge about hypoglycaemia avoidance with psychological therapies that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent severe hypoglycaemia. The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an established educational intervention (Blood Glucose Awareness Training, BGAT) which has also been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic hypoglycaemia persisting despite otherwise optimised insulin self-management will be recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4 centres. The investigators will measure severe hypoglycaemia over two years following courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Type 1 diabetes will be defined clinically, usually based on starting insulin for diabetes within one year of diagnosis and/or a history of diabetic ketoacidosis
✓. Having Gold and Clarke scores of 4 or more and having had ≥ 1 episode/s of severe hypoglycaemia \[events requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective action, because of impaired cognitive function, and which may include episodes that were not treated by another but included loss of consciousness or seizure\] 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) or as judged equivalent by the local investigator.
✓. Participant should be using dose adjustment around carbohydrate counting and lifestyle issues, and an appropriate, separate basal replacement)

What they're measuring

Difference in severe hypoglycaemia between study arms

Timeframe: 12/24 months after randomisation

Trial details

NCT IDNCT02940873

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-01

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials