Impact of a comprehensive digital health programme on HbA1c and weight after 12 months for people with diabetes and prediabetes: a randomised controlled trial.
Open accessAbstract
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, HbA 1c 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 HbA 1c (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 HbA 1c 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%). HbA 1c 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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Despite CDC recognition of digital DPPs since 2015, limited RCT evidence has evaluated their effectiveness, with no trials comparing them directly to the criterion-standard DPP.
“Despite CDC recognition of digital DPPs since 2015, limited RCT evidence has evaluated their effectiveness, with no trials comparing them directly to the criterion-standard DPP.14-19,37”
From An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial (2025) · cites this paper as [15]
The Introduction says evidence for technology-assisted diabetes self-management programmes is mixed, and the Sensitivity analyses section describes scant evidence for subgroups. Neither passage establishes that RCT evidence for digital DPPs is limited; the paper’s trial compares a digital programme with usual care, not the criterion-standard DPP. Our copy does not address CDC recognition since 2015 or establish that no direct-comparison trials existed. (LLM, conf=0.75)
Experimental — accuracy not yet measuredPrior randomized trials of digital DPP adaptations did not include fully automated AI-based experimental groups or a human-led DPP control group.
“Although previous randomized trials have assessed digital adaptations of the DPP, none had experimental groups that were fully automated and AI-based and none used a human-led DPP control group.14-19”
From An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial (2025) · cites this paper as [15]
The Procedures section (page unavailable) describes a digital intervention with individual health coaching and a usual-care control, supporting that this trial had neither a fully automated AI-based intervention nor a human-led DPP control. The paper describes BetaMe/Melon as a diabetes and prediabetes self-management programme, but does not identify it as a digital adaptation of the DPP. It also cannot establish the claim about all previous randomized trials. (LLM, conf=0.82)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., & Conde, J. G. (2009) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2008.08.010 · Cited by 51,384 · see citing works
The REDCap consortium: building an international community of software platform partners
Harris, P. A., Taylor, R., Minor, B. L., Elliott, V., Fernandez, M., O'Neal, L., McLeod, L., Delacqua, G., Delacqua, F., Kirby, J., et al. (2019) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2019.103208 · Cited by 24,013 · see citing works
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
(2002) · New England Journal of Medicine · doi:10.1056/nejmoa012512 · Cited by 19,011 · see citing works
EuroQol: a new facility for the measurement of health-related quality of life
(1990) · Health Policy · doi:10.1016/0168-8510(90)90421-9 · Cited by 15,736 · see citing works
Diabetes Prevention Program Research Group (2009) · The Lancet · doi:10.1016/s0140-6736(09)61457-4 · Cited by 3,020 · see citing works
The summary of diabetes self-care activities measure: results from 7 studies and a revised scale.
Toobert, D. J., Hampson, S. E., & Glasgow, R. E. (2000) · Diabetes Care · doi:10.2337/diacare.23.7.943 · Cited by 2,561 · see citing works
A taxonomy of behavior change techniques used in interventions
Abraham, C., & Michie, S. (2008) · Health Psychology · doi:10.1037/0278-6133.27.3.379 · Cited by 2,525 · see citing works
Lindström, J., Ilanne-Parikka, P., Peltonen, M., Aunola, S., Eriksson, J. G., Hemiö, K., Hämäläinen, H., Härkönen, P., Keinänen-Kiukaanniemi, S., Laakso, M., et al. (2006) · The Lancet · doi:10.1016/s0140-6736(06)69701-8 · Cited by 1,799 · see citing works
Unwin, N. C. (2006) · Cited by 1,661 · see citing works
National Standards for Diabetes Self-Management Education
Funnell, M. M., Brown, T. L., Childs, B. P., Haas, L. B., Hosey, G. M., Jensen, B., Maryniuk, M. D., Peyrot, M. F., Piette, J. D., Reader, D., et al. (2008) · Diabetes Care · doi:10.2337/dc09-s087 · Cited by 1,348 · see citing works
Text messaging as a tool for behavior change in disease prevention and management
Cole-Lewis, H., & Kershaw, T. (2010) · Epidemiologic Reviews · doi:10.1093/epirev/mxq004 · Cited by 1,190 · see citing works
A Primer on Effectiveness and Efficacy Trials
Singal, A. G., Higgins, P. D. R., & Waljee, A. K. (2014) · Clinical and Translational Gastroenterology · doi:10.1038/ctg.2013.13 · Cited by 698 · see citing works
When Is Diabetes Distress Clinically Meaningful?
Fisher, L., Hessler, D. M., Polonsky, W. H., & Mullan, J. (2012) · Diabetes Care · doi:10.2337/dc11-1572 · Cited by 648 · see citing works
Franklin, V. L., Waller, A., Pagliari, C., & Greene, S. A. (2006) · Diabetic Medicine · doi:10.1111/j.1464-5491.2006.01989.x · Cited by 543 · see citing works
Perreault, L., Pan, Q., Mather, K. J., Watson, K. E., Hamman, R. F., & Kahn, S. E. (2012) · The Lancet · doi:10.1016/s0140-6736(12)60525-x · Cited by 532 · see citing works
Greenwood, D. A., Gee, P. M., Fatkin, K. J., & Peeples, M. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817713506 · Cited by 526 · see citing works
Liang, X., Wang, Q., Yang, X., Cao, J., Chen, J., Mo, X., Huang, J., Wang, L., & Gu, D. (2011) · Diabetic Medicine · doi:10.1111/j.1464-5491.2010.03180.x · Cited by 515 · see citing works
National Standards for Diabetes Self-Management Education
Funnell, M. M., Brown, T. L., Childs, B. P., Haas, L. B., Hosey, G. M., Jensen, B., Maryniuk, M. D., Peyrot, M. F., Piette, J. D., Reader, D., et al. (2007) · Diabetes Care · doi:10.2337/dc08-s097 · Cited by 494 · see citing works
Development of a brief diabetes distress screening instrument
Fisher, L., Glasgow, R. E., Mullan, J. T., Skaff, M. M., & Polonsky, W. H. (2008) · The Annals of Family Medicine · doi:10.1370/afm.842 · Cited by 474 · see citing works
Integrated Theory of Health Behavior Change
Ryan, P. A. (2009) · Clinical Nurse Specialist · doi:10.1097/nur.0b013e3181a42373 · Cited by 410 · see citing works
Glasgow, R. E., Funnell, M. M., Bonomi, A. E., Davis, C., Beckham, V., & Wagner, E. H. (2002) · Annals of Behavioral Medicine · doi:10.1207/s15324796abm2402_04 · Cited by 376 · see citing works
Heymsfield, S. B., Segal, K. R., Hauptman, J., Lucas, C. P., Boldrin, M. N., Rissanen, A., Wilding, J. P. H., & Sjöström, L. (2000) · Archives of Internal Medicine · doi:10.1001/archinte.160.9.1321 · Cited by 358 · see citing works
Shan, R., Sarkar, S., & Martin, S. S. (2019) · Diabetologia · doi:10.1007/s00125-019-4864-7 · Cited by 339 · see citing works
Peer Support For Self-Management Of Diabetes Improved Outcomes In International Settings
Fisher, E. B., Boothroyd, R. I., Coufal, M. M., Baumann, L. C., Mbanya, J. C., Rotheram‐Borus, M. J., Sanguanprasit, B., & Tanasugarn, C. (2012) · Health Affairs · doi:10.1377/hlthaff.2011.0914 · Cited by 310 · see citing works
Thom, D. H., Ghorob, A., Hessler, D., Vore, D. D., Chen, E., & Bodenheimer, T. (2013) · The Annals of Family Medicine · doi:10.1370/afm.1443 · Cited by 304 · see citing works
Pedišić, Ž., Bennie, J. A., Timperio, A. F., Crawford, D. A., Dunstan, D. W., Bauman, A. E., & Salmon, J. (2014) · BMC Public Health · doi:10.1186/1471-2458-14-1249 · Cited by 254 · see citing works
Garvey, W. T., Ryan, D. H., Henry, R., Bohannon, N. J. V., Toplak, H., Schwiers, M., Troupin, B., & Day, W. W. (2014) · Diabetes Care · doi:10.2337/dc13-1518 · Cited by 215 · see citing works
Diabetes Self-Management: Self-reported recommendations and patterns in a large population
Ruggiero, L., Glasgow, R. E., Dryfoos, J. M., Rossi, J. S., Prochaska, J. O., Orleans, C. T., Prokhorov, A., Rossi, S. R., Greene, G. W., Reed, G. R., et al. (1997) · Diabetes Care · doi:10.2337/diacare.20.4.568 · Cited by 190 · see citing works
Chronic disease self‐management education programs: challenges ahead
Jordan, J. M., & Osborne, R. H. (2007) · The Medical Journal of Australia · doi:10.5694/j.1326-5377.2007.tb00807.x · Cited by 184 · see citing works
Nundy, S., Dick, J. J., Chou, C.-H., Nocon, R. S., Chin, M. H., & Peek, M. E. (2014) · Health Affairs · doi:10.1377/hlthaff.2013.0589 · Cited by 144 · see citing works
Captieux, M., Pearce, G., Parke, H. L., Epiphaniou, E., Wild, S., Taylor, S. J. C., & Pinnock, H. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-024262 · Cited by 132 · see citing works
Hou, C., Xu, Q., Diao, S., Hewitt, J., Li, J., & Carter, B. (2018) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13307 · Cited by 127 · see citing works
Dietary habits in type II diabetes mellitus: how is adherence to dietary recommendations?
Rivellese, A. A., Boemi, M., Cavalot, F. L., Costagliola, L., Feo, P. D., Miccoli, R., Patti, L., Trovati, M., Vaccaro, O., Zavaroni, I., et al. (2007) · European Journal of Clinical Nutrition · doi:10.1038/sj.ejcn.1602755 · Cited by 86 · see citing works
Effects of Providing Peer Support on Diabetes Management in People With Type 2 Diabetes
Yin, J. J., Wong, R. Y. M., Au, S., Chung, H. G., Lau, M., Lin, L., Tsang, C., Lau, K., Ozaki, R., So, W. Y., et al. (2015) · The Annals of Family Medicine · doi:10.1370/afm.1853 · Cited by 82 · see citing works
Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial
Fischer, H. H., Fischer, I. P., Pereira, R. I., Furniss, A., Rozwadowski, J. M., Moore, S. L., Durfee, M. J., Raghunath, S., Tsai, A. G., & Havranek, E. P. (2016) · Diabetes Care · doi:10.2337/dc15-2137 · Cited by 82 · see citing works
Smith, D., Harvey, P. W., Lawn, S., Harris, M., & Battersby, M. (2016) · Quality of Life Research · doi:10.1007/s11136-016-1368-5 · Cited by 72 · see citing works
Hadjiconstantinou, M., Byrne, J. L., Bodicoat, D. H., Robertson, N., Eborall, H., Khunti, K. K., & Davies, M. J. (2016) · Journal of Medical Internet Research · doi:10.2196/jmir.5991 · Cited by 63 · see citing works
A Virtual Clinic for Diabetes Self-Management: Pilot Study
Jennings, A., powell, J. A., Armstrong, N., Sturt, J. A., & Dale, J. R. (2009) · Journal of Medical Internet Research · doi:10.2196/jmir.1111 · Cited by 55 · see citing works
Wolever, R. Q., & Dreusicke, M. (2016) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2016-000201 · Cited by 54 · see citing works
Vissenberg, C., Stronks, K., Nijpels, G., Uitewaal, P. J. M., Middelkoop, B. J., Kohinor, M. J. E., Hartman, M. A., & Nierkens, V. (2016) · BMJ Open · doi:10.1136/bmjopen-2015-010254 · Cited by 34 · see citing works
Sarfati, D., McLeod, M., Stanley, J., Signal, V., Stairmand, J., Krebs, J. D., Dowell, A. C., Leung, W. C. Y., Davies, C., & Grainger, R. (2018) · Trials · doi:10.1186/s13063-018-2528-4 · Cited by 18 · see citing works
Self-citationClarke, D. M., Baird, D. E., Perera, D. N., Hagger, V. L., & Teede, H. J. (2014) · BMC Public Health · doi:10.1186/1471-2458-14-134 · Cited by 11 · see citing works
Vinik, A. I., & Richardson, D. W. (1997) · Southern Medical Journal · doi:10.1097/00007611-199703000-00001 · Cited by 7 · see citing works
Yamada, T., Kiuchi, Y., Nemoto, M., & Yamashita, S. (2013) · Diabetes and Vascular Disease Research · doi:10.1177/1479164113508141 · Cited by 4 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Moschonis, G., Siopis, G., Jung, J., Eweka, E., Willems, R., Kwasnicka, D., Asare, B. Y.-A., Kodithuwakku, V., Verhaeghe, N., Vedanthan, R., et al. (2023) · The Lancet Digital Health · doi:10.1016/s2589-7500(22)00233-3 · Cited by 149 · see citing works
Mathioudakis, N., Lalani, B., Abusamaan, M. S., Alderfer, M., Alver, D., Dobs, A., Kane, B., McGready, J., Riekert, K., Ringham, B., et al. (2025) · JAMA · doi:10.1001/jama.2025.19563 · Cited by 41 · see citing works
- Authors
- McLeod, M., Stanley, J., Signal, V., Stairmand, J., Thompson, D., Henderson, K., Davies, C., Krebs, J., Dowell, A., Grainger, R., & Sarfati, D.
- Affiliations
- University of Otago (NZ)
- Corresponding author
- McLeod, Melissa
- ORCID
- Venue
- Diabetologia
- Published
- 2020-09-04
- Volume
- 63
- Issue
- 12
- Pages
- 2559-2570
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W3083332107
- Cited by
- 36
- References
- 44
- Citations by year
- 2026: 5 · 2025: 9 · 2024: 10 · 2023: 2 · 2022: 3 · 2021: 6 · 2020: 1
- FWCI
- 3.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Ministry of Health New Zealand
- Health Research Council of New Zealand (16/727)
- Healthier Lives National Science Challenge
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- digital health interventions, type 2 diabetes, prediabetes, HbA1c, glycemic control, weight loss, mobile health, online intervention, health coaching, peer support, goal tracking, primary care, usual care comparison, intervention effectiveness, digital divide, diabetes self-management education
- MeSH terms
- Adult, Aged, Body Weight, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Insulin, Male, Middle Aged, Prediabetic State
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
