Imperial College London

DR IOANNIS BAKOLIS

Faculty of MedicineSchool of Public Health

Honorary Research Associate
 
 
 
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Contact

 

+44 (0)20 7594 3277i.bakolis Website

 
 
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Location

 

531Norfolk PlaceSt Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Amiel:2019:10.1136/bmjopen-2019-030356,
author = {Amiel, SA and Choudhary, P and Jacob, P and Smith, EL and De, Zoysa N and Gonder-Frederick, L and Kendall, M and Heller, S and Brooks, A and Toschi, E and Kariyawasam, D and Potts, L and Healy, A and Rogers, H and Sevdalis, N and Stadler, M and Qayyum, M and Bakolis, I and Goldsmith, K},
doi = {10.1136/bmjopen-2019-030356},
journal = {BMJ Open},
title = {Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions.},
url = {http://dx.doi.org/10.1136/bmjopen-2019-030356},
volume = {9},
year = {2019}
}

RIS format (EndNote, RefMan)

TY  - JOUR
AB - INTRODUCTION: Severe hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence. METHODS AND ANALYSIS: A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol. ETHICS AND DISSEMINATION: The protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be di
AU - Amiel,SA
AU - Choudhary,P
AU - Jacob,P
AU - Smith,EL
AU - De,Zoysa N
AU - Gonder-Frederick,L
AU - Kendall,M
AU - Heller,S
AU - Brooks,A
AU - Toschi,E
AU - Kariyawasam,D
AU - Potts,L
AU - Healy,A
AU - Rogers,H
AU - Sevdalis,N
AU - Stadler,M
AU - Qayyum,M
AU - Bakolis,I
AU - Goldsmith,K
DO - 10.1136/bmjopen-2019-030356
PY - 2019///
TI - Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions.
T2 - BMJ Open
UR - http://dx.doi.org/10.1136/bmjopen-2019-030356
UR - https://www.ncbi.nlm.nih.gov/pubmed/31209097
VL - 9
ER -