Hypoglycaemia Awareness Restoration Programme

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus, Hypoglycemia

In brief

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.

Key facts

Study ID: NCT02940873
Run by: King's College London
People needed: 99
Starts: 2017-03-09
Expected to finish: 2021-04-27
Last updated by the study team: 2021-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

96 people, of whom 24 will be recruited in the US centre under their ethical regulations.
18 years or older
type 1 diabetes(1) for at least four years,
Experiencing problematic hypoglycaemia(2) for at least one year, despite structured education(3) in flexible insulin therapy and on-going optimal conventional care.
Current use of an appropriate (in the investigator's estimation) multiple daily insulin injection regimen or CSII (insulin pump) therapy(4)
Willingness to comply with study design, including willingness and ability to perform SMBG up to 4 times a day routinely
Ability to communicate in written and spoken English
Ability to give written informed consent.
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)

You may not qualify if…

People with type 2 diabetes, or 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 (DO IT) or as judged equivalent by the local investigator.
People not fluent in spoken English
Current pregnancy (5)
People with severe mental disorders (schizophrenia, manic depression, depressive psychosis, active suicidal ideation, learning disability, dementia, alcohol and substance dependence, personality disorders, eating disorder)(6).
Cognitive impairment independent of hypoglycaemia (e.g. clinical diagnosis of dementia(7), 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), which must have been checked since the onset of problematic hypoglycaemia.
(5) Participants who continue to experience severe hypoglycaemia episodes 6 months after they have stopped breastfeeding may be included in the trial.
(6) "Manic depression" covers conditions such as 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
(7) Dementia would cover either an existing diagnosis or a Mini Mental State Examination [MMSE]) score of less than 24.
Participants who have expressed interest in the study, have consented, and have impaired awareness of hypoglycaemia but do not otherwise meet the inclusion criteria due to low number of SH episodes may be included in the HARPdoc educational course as 'fillers' if space is available. These patients will not be randomised, nor entered into the study database. However, they may be asked to complete the open baseline, 12 and 24-month data collection if they agree to do so.

Where it is running

Joslin Diabetes Center — Boston, Massachusetts, United States
Royal Bournemouth Hospital — Bournemouth, United Kingdom
King's College Hospital NHS Foundation Trust and Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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