Melissa McLeod1, James Stanley2, Virginia Signal2, Jeannine Stairmand2, Donna Thompson2,3, Kelly Henderson2,4, Cheryl Davies5, Jeremy Krebs6, Anthony Dowell7, Rebecca Grainger6, Diana Sarfati2. 1. Department of Public Health, University of Otago, Wellington, New Zealand. melissa.mcleod@otago.ac.nz. 2. Department of Public Health, University of Otago, Wellington, New Zealand. 3. , Masterton, New Zealand. 4. , Hamilton, New Zealand. 5. Kokiri Marae, Seaview, Wellington, New Zealand. 6. Department of Medicine, University of Otago, Wellington, New Zealand. 7. Department Primary Health Care and General Practice, University of Otago, Wellington, New Zealand.
Abstract
AIMS/HYPOTHESIS: The aim of this RCT was to evaluate the effectiveness of a digital health programme (BetaMe/Melon) vs usual care in improving the control of type 2 diabetes and prediabetes in a primary care population. METHODS: We conducted a randomised parallel-group two-arm single-blinded superiority trial in the primary care setting in two regions of New Zealand. Eligible participants were identified through Primary Health Organisations and participating practices. Eligibility criteria were as follows: age 18-75 years, HbA1c 41-70 mmol/mol (5.9-8.6%), not taking insulin, and daily access to the internet. BetaMe/Melon is a 12 month mobile-device and web-based programme with four components: health coaching; evidence-based resources; peer support; and goal tracking. Participants were randomised into the intervention or control arm (1:1 allocation) based upon baseline HbA1c (prediabetes or diabetes range), stratified by practice and ethnicity. Research nurses and the study biostatistician were blind to study arm. Primary outcomes of the study were changes in HbA1c and weight at 12 months, using an intention-to-treat analysis. RESULTS:Four hundred and twenty-nine individuals were recruited between 20 June 2017 and 11 May 2018 (n = 215 intervention arm, n = 214 control arm), most of whom were included in analyses of co-primary outcomes (n = 210/215, 97.7% and n = 213/214, 99.5%). HbA1c levels at 12 months did not differ between study arms: mean difference was -0.9 mmol/mol (95% CI -2.9, 1.1) (-0.1% [95% CI -0.3, 0.1]) for the diabetes group and was 0.0 mmol/mol (95% CI -0.9, 0.9) (0.0% [95% CI -0.1, 0.1]) for the prediabetes group. Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference -0.4 kg [95% CI -1.3, 0.5]). CONCLUSIONS/ INTERPRETATION: This study did not demonstrate clinical effectiveness for this particular programme. Given their high costs, technology-assisted self-management programmes need to be individually assessed for their effectiveness in improving clinical outcomes for people with diabetes. TRIAL REGISTRATION: www.anzctr.org.au ACTRN12617000549325 (universal trial number U1111-1189-9094) FUNDING: This study was funded by the Health Research Council of New Zealand, the Ministry of Health New Zealand and the Healthier Lives National Science Challenge. Graphical abstract.
RCT Entities:
AIMS/HYPOTHESIS: The aim of this RCT was to evaluate the effectiveness of a digital health programme (BetaMe/Melon) vs usual care in improving the control of type 2 diabetes and prediabetes in a primary care population. METHODS: We conducted a randomised parallel-group two-arm single-blinded superiority trial in the primary care setting in two regions of New Zealand. Eligible participants were identified through Primary Health Organisations and participating practices. Eligibility criteria were as follows: age 18-75 years, HbA1c 41-70 mmol/mol (5.9-8.6%), not taking insulin, and daily access to the internet. BetaMe/Melon is a 12 month mobile-device and web-based programme with four components: health coaching; evidence-based resources; peer support; and goal tracking. Participants were randomised into the intervention or control arm (1:1 allocation) based upon baseline HbA1c (prediabetes or diabetes range), stratified by practice and ethnicity. Research nurses and the study biostatistician were blind to study arm. Primary outcomes of the study were changes in HbA1c and weight at 12 months, using an intention-to-treat analysis. RESULTS: Four hundred and twenty-nine individuals were recruited between 20 June 2017 and 11 May 2018 (n = 215 intervention arm, n = 214 control arm), most of whom were included in analyses of co-primary outcomes (n = 210/215, 97.7% and n = 213/214, 99.5%). HbA1c levels at 12 months did not differ between study arms: mean difference was -0.9 mmol/mol (95% CI -2.9, 1.1) (-0.1% [95% CI -0.3, 0.1]) for the diabetes group and was 0.0 mmol/mol (95% CI -0.9, 0.9) (0.0% [95% CI -0.1, 0.1]) for the prediabetes group. Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference -0.4 kg [95% CI -1.3, 0.5]). CONCLUSIONS/ INTERPRETATION: This study did not demonstrate clinical effectiveness for this particular programme. Given their high costs, technology-assisted self-management programmes need to be individually assessed for their effectiveness in improving clinical outcomes for people with diabetes. TRIAL REGISTRATION: www.anzctr.org.au ACTRN12617000549325 (universal trial number U1111-1189-9094) FUNDING: This study was funded by the Health Research Council of New Zealand, the Ministry of Health New Zealand and the Healthier Lives National Science Challenge. Graphical abstract.