NCT02940873: HARPdoc

Hypoglycaemia Awareness Restoration Programme

Completed NA Last updated 2 September 2021

What this trial tests

NA trial testing HARPdoc courses in Type 1 Diabetes Mellitus in 99 participants. Completed in 27 April 2021.

Timeline

9 March 2017

Primary endpoint
1 April 2021

27 April 2021

Quick facts

Lead sponsor	King's College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	99
Start date	9 March 2017
Primary completion	1 April 2021
Estimated completion	27 April 2021
Sites	4 locations across United Kingdom, United States

Drugs / interventions tested

• HARPdoc courses
• BGAT courses

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
• Hypoglycemia — all drugs for Hypoglycemia →

Sponsor

King's College London

Who can join

18 and older, any sex, with Type 1 Diabetes Mellitus or Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc).
   Amiel SA, Potts L, Goldsmith K, Jacob P, et al · · 2022 · cited 47× · PMID 35484106 · DOI 10.1038/s41467-022-29488-x
2. Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol.
   Soukup T, Hull L, Smith EL, Healey A, et al · · 2019 · cited 11× · PMID 31727650 · DOI 10.1136/bmjopen-2019-030370
3. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
4. Mitigating Severe Hypoglycemia in Users of Advanced Diabetes Technologies: Impaired Awareness of Hypoglycemia and Unhelpful Hypoglycemia Beliefs as Targets for Interventions.
   Lin YK, Ye W, Rogers H, Brooks A, et al · · 2024 · cited 6× · PMID 38662427 · DOI 10.1089/dia.2024.0039
5. Proceedings of the Virtual 3^rd UK Implementation Science Research Conference : Virtual conference. 16 and 17 July 2020.
   · 2020 · cited 1× · PMID 33327951 · DOI 10.1186/s13012-020-01062-3
6. Proceedings from the 2nd Annual UK Implementation Science Research Conference, 'Advancing the science of scaling up: Improving efficiency and effectiveness of implementation strategies in healthcare': meeting abstracts : London, United Kingdom. 18 July 2019.
   · 2019 · cited 1× · PMID 31288839 · DOI 10.1186/s13012-019-0911-5
7. Psychoeducation for adults with type 1 diabetes and problematic hypoglycemia: implementation analysis of a clinical trial (HARPdoc)
   Soukup T, Cross S, Amiel S, Goldsmith K, et al ·
8. Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.
   Healey A, Soukup T, Sevdalis N, Bakolis I, et al · · 2024 · PMID 38421806 · DOI 10.1111/dme.15304