Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial

Sampson, Michael, Clark, Allan ORCID: https://orcid.org/0000-0003-2965-8941, Bachmann, Max ORCID: https://orcid.org/0000-0003-1770-3506, Garner, Nikki ORCID: https://orcid.org/0000-0002-3514-5950, Irvine, Lisa ORCID: https://orcid.org/0000-0003-1936-3584, Howe, Amanda, Greaves, Colin, Auckland, Sara, Smith, Jane, Rea, Dave, Turner, Jeremy, Rayman, Gerry, Dhatariya, Ketan, John, W. Garry, Barton, Garry, Usher, Rebecca, Ferns, Clare and Pascale, Melanie and on behalf of the NDPS group (2021) Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial. BMC Medicine, 19 (1). ISSN 1741-7015

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BACKGROUND: The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes.  METHODS: We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months.  RESULTS: We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference -2.57 mmol/mol; 95% CI -4.5, -0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (-0.55 mmol/mol; 95% CI -2.46, 1.35; p = 0.57), or INT vs CON arms (-2.14 mmol/mol; 95% CI -4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON -4.76 mmol/mol; 95% CI -7.75, -1.78 mmol/mol) than in older participants (-0.46 mmol/mol; 95% CI -2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (-6.01 mmol/mol; 95% CI -9.56, -2.46 age < 65 years old and -0.22 mmol/mol; 95% CI -2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (-7.0 mmol/mol; 95% CI -11.5, -2.5; p = 0.003).  CONCLUSION: The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months.  TRIAL REGISTRATION: ISRCTN34805606 . Retrospectively registered 14.4.16.

Item Type: Article
Additional Information: Funding Information: The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit. This work was funded by the National Institute of Health Research (NIHR) Programme Grant NIHR RP - PG – 0109 – 10013 . This article presents independent research funded by the National Institute for Health Research (NIHR) under the Programme Grants for Applied Research programme. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Publisher Copyright: © 2021, The Author(s).
Uncontrolled Keywords: diabetes prevention mentors,glycaemic control,lifestyle intervention,peer support,screen detected,type 2 diabetes,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Faculty of Medicine and Health Sciences > School of Health Sciences
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Depositing User: LivePure Connector
Date Deposited: 25 Aug 2021 09:54
Last Modified: 03 Mar 2023 02:19
URI: https://ueaeprints.uea.ac.uk/id/eprint/81205
DOI: 10.1186/s12916-021-02053-x

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