Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes

Elizabeth Coates; S Amiel; Wendy Baird; Mohammed Benaissa; Alan Brennan; Michael Joseph Campbell; Paul Chadwick; Tim Chater; Pratik Choudhary; Debbie Cooke; Cindy Cooper; Elizabeth Cross; Nicole De Zoysa; Mohammad Eissa; Jackie Elliott; Carla Gianfrancesco; Tim Good; David Hopkins; Zheng Hui; Julia Lawton; Fabiana Lorencatto; Susan F Michie; Daniel John Pollard; David Rankin; Jose Schutter; Elaine Scott; Jane Speight; Stephanie Stanton-Fay; Carolin Taylor; Gillian Thompson; Nikki Totton; Lucy Yardley; Alexsandr Zaitcev; Simon Heller

doi:10.1136/bmjopen-2020-040438

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes

Elizabeth Coates, S Amiel, Wendy Baird, Mohammed Benaissa, Alan Brennan, Michael Joseph Campbell, Paul Chadwick, Tim Chater , Pratik Choudhary, Debbie Cooke, Cindy Cooper, Elizabeth Cross, Nicole De Zoysa, Mohammad Eissa, Jackie Elliott, Carla Gianfrancesco, Tim Good, David Hopkins, Zheng Hui, Julia LawtonFabiana Lorencatto, Susan F Michie, Daniel John Pollard , David Rankin, Jose Schutter, Elaine Scott, Jane Speight, Stephanie Stanton-Fay, Carolin Taylor, Gillian Thompson, Nikki Totton, Lucy Yardley, Alexsandr Zaitcev, Simon Heller^*

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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Abstract

Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment for Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short-term (manifest by falls in HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behaviour change techniques, technology and longer-term structured support from healthcare professionals.
Methods and analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in NHS secondary care hospitals in the United Kingdom. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c (glycated haemoglobin) and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.
Ethics and dissemination: Ethics approval was granted by South West – Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14th May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.
Trial registration: ISRCTN42908016 – registered on 17th May 2018

Original language	English
Article number	e040438
Pages (from-to)	e040438
Number of pages	11
Journal	BMJ Open
Volume	11
Issue number	1
DOIs	https://doi.org/10.1136/bmjopen-2020-040438
Publication status	Published - 18 Jan 2021

Bibliographical note

This work is funded by the National Institute for Health Research through their Programme Grants for Applied Research Programme (Ref: RP-PG-0514-20013) and NHS England provide funding for Excess Treatment Costs.

Research Groups and Themes

Physical and Mental Health

Keywords

diabetes mellitus, type 1
self management
patient education
randomised controlled trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Coates, E., Amiel, S., Baird, W., Benaissa, M., Brennan, A., Campbell, M. J., Chadwick, P., Chater , T., Choudhary, P., Cooke, D., Cooper, C., Cross, E., De Zoysa, N., Eissa, M., Elliott, J., Gianfrancesco, C., Good, T., Hopkins, D., Hui, Z., ... Heller, S. (2021). Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes. BMJ Open, 11(1), e040438. Article e040438. https://doi.org/10.1136/bmjopen-2020-040438

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abstract = "Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment for Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short-term (manifest by falls in HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behaviour change techniques, technology and longer-term structured support from healthcare professionals.Methods and analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in NHS secondary care hospitals in the United Kingdom. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c (glycated haemoglobin) and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.Ethics and dissemination: Ethics approval was granted by South West – Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14th May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.Trial registration: ISRCTN42908016 – registered on 17th May 2018",

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author = "Elizabeth Coates and S Amiel and Wendy Baird and Mohammed Benaissa and Alan Brennan and Campbell, {Michael Joseph} and Paul Chadwick and Tim Chater and Pratik Choudhary and Debbie Cooke and Cindy Cooper and Elizabeth Cross and {De Zoysa}, Nicole and Mohammad Eissa and Jackie Elliott and Carla Gianfrancesco and Tim Good and David Hopkins and Zheng Hui and Julia Lawton and Fabiana Lorencatto and Michie, {Susan F} and Pollard, {Daniel John} and David Rankin and Jose Schutter and Elaine Scott and Jane Speight and Stephanie Stanton-Fay and Carolin Taylor and Gillian Thompson and Nikki Totton and Lucy Yardley and Alexsandr Zaitcev and Simon Heller",

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Coates, E, Amiel, S, Baird, W, Benaissa, M, Brennan, A, Campbell, MJ, Chadwick, P, Chater , T, Choudhary, P, Cooke, D, Cooper, C, Cross, E, De Zoysa, N, Eissa, M, Elliott, J, Gianfrancesco, C, Good, T, Hopkins, D, Hui, Z, Lawton, J, Lorencatto, F, Michie, SF, Pollard , DJ, Rankin, D, Schutter, J, Scott, E, Speight, J, Stanton-Fay, S, Taylor, C, Thompson, G, Totton, N, Yardley, L, Zaitcev, A & Heller, S 2021, 'Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes', BMJ Open, vol. 11, no. 1, e040438, pp. e040438. https://doi.org/10.1136/bmjopen-2020-040438

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes. / Coates, Elizabeth; Amiel, S; Baird, Wendy et al.
In: BMJ Open, Vol. 11, No. 1, e040438, 18.01.2021, p. e040438.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE

T2 - A lifelong approach to promote effective self-management in adults with type 1 diabetes

AU - Coates, Elizabeth

AU - Amiel, S

AU - Baird, Wendy

AU - Benaissa, Mohammed

AU - Brennan, Alan

AU - Campbell, Michael Joseph

AU - Chadwick, Paul

AU - Chater , Tim

AU - Choudhary, Pratik

AU - Cooke, Debbie

AU - Cooper, Cindy

AU - Cross, Elizabeth

AU - De Zoysa, Nicole

AU - Eissa, Mohammad

AU - Elliott, Jackie

AU - Gianfrancesco, Carla

AU - Good, Tim

AU - Hopkins, David

AU - Hui, Zheng

AU - Lawton, Julia

AU - Lorencatto, Fabiana

AU - Michie, Susan F

AU - Pollard , Daniel John

AU - Rankin, David

AU - Schutter, Jose

AU - Scott, Elaine

AU - Speight, Jane

AU - Stanton-Fay, Stephanie

AU - Taylor, Carolin

AU - Thompson, Gillian

AU - Totton, Nikki

AU - Yardley, Lucy

AU - Zaitcev, Alexsandr

AU - Heller, Simon

N1 - This work is funded by the National Institute for Health Research through their Programme Grants for Applied Research Programme (Ref: RP-PG-0514-20013) and NHS England provide funding for Excess Treatment Costs.

PY - 2021/1/18

Y1 - 2021/1/18

N2 - Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment for Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short-term (manifest by falls in HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behaviour change techniques, technology and longer-term structured support from healthcare professionals.Methods and analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in NHS secondary care hospitals in the United Kingdom. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c (glycated haemoglobin) and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.Ethics and dissemination: Ethics approval was granted by South West – Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14th May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.Trial registration: ISRCTN42908016 – registered on 17th May 2018

AB - Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment for Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short-term (manifest by falls in HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behaviour change techniques, technology and longer-term structured support from healthcare professionals.Methods and analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in NHS secondary care hospitals in the United Kingdom. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c (glycated haemoglobin) and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.Ethics and dissemination: Ethics approval was granted by South West – Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14th May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.Trial registration: ISRCTN42908016 – registered on 17th May 2018

KW - diabetes mellitus, type 1

KW - self management

KW - patient education

KW - randomised controlled trial

U2 - 10.1136/bmjopen-2020-040438

DO - 10.1136/bmjopen-2020-040438

M3 - Article (Academic Journal)

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SN - 2044-6055

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SP - e040438

JO - BMJ Open

JF - BMJ Open

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Coates E, Amiel S, Baird W, Benaissa M, Brennan A, Campbell MJ et al. Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes. BMJ Open. 2021 Jan 18;11(1):e040438. e040438. doi: 10.1136/bmjopen-2020-040438