DIVINE–pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in Australia

Angela Xun-Nan Chen; Vivian Y Lee; Katherine Donges; Chris Giancas; Blake Angell; Belinda Parmenter; Helen L Barrett; Amanda Henry; Anushka Patel; Clare Arnott

doi:10.1136/bmjopen-2025-107551

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DIVINE–pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in Australia

Journal article

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DIVINE–pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in Australia

Angela Xun-Nan Chen, Vivian Y Lee, Katherine Donges, Chris Giancas, Blake Angell, Belinda Parmenter, Helen L Barrett, Amanda Henry, Anushka Patel and Clare Arnott

BMJ Open, Vol.15(12), pp.1-9

2025

DOI: https://doi.org/10.1136/bmjopen-2025-107551

PMCID: PMC12706213

PMID: 41386999

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Abstract

Cardiovascular Disease

Cardiovascular medicine

Diabetes in pregnancy

Diabetes Mellitus, Type 2

Obesity

Overweight

Randomized Controlled Trial

Introduction: Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM. Methods and analysis: This will be a multicentre, randomised, open-label interventional pilot study. Using a 2×2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events. Ethics and dissemination: This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025). Trial registration number: Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

Details

Title: DIVINE–pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in Australia
Authors: Angela Xun-Nan Chen (Corresponding Author) - Westmead Hospital
Vivian Y Lee - The George Institute for Global Health
Katherine Donges
Chris Giancas - The George Institute for Global Health
Blake Angell - The George Institute for Global Health
Belinda Parmenter - University of the Sunshine Coast, Queensland, School of Health - Sports & Exercise Science
Helen L Barrett - UNSW Sydney
Amanda Henry - St George Hospital
Anushka Patel - The George Institute for Global Health
Clare Arnott - Royal Prince Alfred Hospital
Publication details: BMJ Open, Vol.15(12), pp.1-9
Publisher: BMJ Group
Date published: 2025
DOI: 10.1136/bmjopen-2025-107551
ISSN: 2044-6055
PMID: 41386999; PMC12706213
Copyright note: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Grants: Prevention of cardiometabolic conditions in diverse populations, 2016801, National Health and Medical Research Council (Australia, Canberra) - NHMRC
Grant note: Cardiac Vascular and Metabolic Medicine Theme Coll / University of New South Wales (http://dx.doi.org/10.13039/501100001773).
Organisation Unit: School of Health - Sports & Exercise Science
Language: English
Record Identifier: 991192243702621
Output Type: Journal article

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Web Of Science research areas: Endocrinology & Metabolism

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