Hypoglycaemia Awareness Restoration Programme

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.

Conditions

• Type 1 Diabetes Mellitus
• Hypoglycemia

Interventions

BEHAVIORAL

HARPdoc courses

A six week group education package including hypoglycaemia-focussed cognitive behavioural therapy

BEHAVIORAL

BGAT courses

A structured psycho-education programme focussing on better prediction and recognition of high and low blood glucose values

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Joslin Diabetes Center

  collaborator OTHER

• King's College London

  lead OTHER

Principal Investigators

• Stephanie A Amiel, MB, MD, FRCP · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-09

Primary Completion

2021-04-01

Completion

2021-04-27

Countries

• United States
• United Kingdom

Study Locations