A Systematic Literature Review of Randomized Trials Comparing In-Person and Digital Interventions for Type 2 Diabetes Prevention.

Abstract

Background: Digital and in–person lifestyle interventions to prevent type 2 diabetes (T2DM) are being increasingly implemented in some countries, particularly in the United States. However, their comparative effectiveness remains unclear, partly due to variability in intervention designs and limited robust evidence from randomized controlled trials (RCTs). Understanding their relative impacts is critical for informing evidence-based implementation in diverse healthcare settings. Aim: To compare the effectiveness of digital versus in–person interventions for preventing T2DM. Methods: We conducted a systematic literature review, following Cochrane methodology to identify and synthesize evidence from RCTs. Searches were conducted in EMBASE, MEDLINE, and Cochrane CENTRAL from inception to December 2024, including completed and ongoing trials published in English or Spanish. Studies comparing purely digital and in–person interventions were eligible. Meta–analyses were performed where appropriate, and narrative syntheses were provided for remaining outcomes. The GRADE approach was used to assess the certainty of evidence. Results: Eight RCTs met the inclusion criteria, including six completed trials with published results and two ongoing trials. The completed trials encompassed a total of 2,450 participants across various healthcare settings. At 12 months, digital interventions were associated with significantly greater weight loss than in-person interventions (mean difference: –1.38 kg [95% CI: –2.34 to –0.43]), with moderate certainty of evidence. At shorter (3 and 6 months) and longer (>12 months) time points, no relevant differences were observed for weight, body mass index, or glycosylated haemoglobin levels between the modalities, with the certainty of evidence rated as low to very low. Evidence about cost–effectiveness was scarce. No trials evaluated key outcomes such as incidence of T2DM or health-related quality. For adverse events, no significant differences were found between modalities (RR: 1.06 [95% CI: 0.45 to 2.50]). Conclusions: This systematic review highlights that while digital and in–person interventions can both be effective for T2DM prevention, their relative benefits depend on follow–up duration and contextual factors. The limited certainty of evidence and the absence of trials addressing critical outcomes, such as T2DM incidence, underscore the need for further well–designed RCTs. Future research should prioritize equivalence in intervention intensity, longer follow–up durations, and standardized reporting of outcomes to better inform public health decision–making.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

IRC is funded by Instituto de Salud Carlos III, grant number CP17/00017. RZC was funded by Instituto de Investigacion Sanitaria de las Islas Baleares, grant number FOLIUM–2023 (founded by ITS2023/057). The rest of the authors are not funded by any grant or award to develop this work. The funders had no role in study design nor preparation of the protocol.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study used openly available human data that were originally located at: 1. Abusamaan, M.S., et al., Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial. Trials, 2024. 25(1): p. 325. 2. Almeida, F.A., et al., Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol. Contemporary clinical trials, 2020. 88: p. 105877. 3. Almeida, F.A., et al., Design and methods of "diaBEAT-it!": a hybrid preference/randomized control trial design using the RE-AIM framework. Contemporary clinical trials, 2014. 38(2): p. 383-96. 4. Almeida, F.A., et al., A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study. Frontiers in public health, 2023. 11: p. 1000162. 5. Beasley, J.M., et al., Study protocol: BRInging the Diabetes prevention program to GEriatric Populations. Frontiers in medicine, 2023. 10: p. 1144156. 6. Ferrara, A., et al., Comparative Effectiveness of 2 Diabetes Prevention Lifestyle Programs in the Workplace: The City and County of San Francisco Diabetes Prevention Trial. Preventing chronic disease, 2020. 17: p. E38. 7. Katula, J.A., et al., Effects of a Digital Diabetes Prevention Program: An RCT. American journal of preventive medicine, 2022. 62(4): p. 567-577. 8. Ma, J., et al., Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA internal medicine, 2013. 173(2): p. 113-21. 9. Michaud, T.L., et al., Effects of a digital diabetes prevention program on cardiovascular risk among individuals with prediabetes. Primary care diabetes, 2023. 17(2): p. 148-154. 10. Michaud, T.L., et al., Cost and cost-effectiveness analysis of a digital diabetes prevention program: results from the PREDICTS trial. Translational behavioral medicine, 2023. 13(7): p. 501-510. 11. Moravcova, K., et al., Comparing the Efficacy of Digital and In-Person Weight Loss Interventions for Patients with Obesity and Glycemic Disorders: Evidence from a Randomized Non-Inferiority Trial. Nutrients, 2024. 16(10). 12. Nct, Preventing Diabetes With Digital Health and Coaching. https://clinicaltrials.gov/show/NCT03312764, 2017. 13. Nct, Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs. https://clinicaltrials.gov/ct2/show/NCT05056376, 2021. 14. Padilla, H.M., et al., Reach, Uptake, and Satisfaction of Three Delivery Modes of <ovid:i>FUEL Your Life</ovid:i>. Health promotion practice, 2021. 22(3): p. 415-422. 15. Park, S., et al., Cost-effectiveness analysis of a digital Diabetes Prevention Program (dDPP) in prediabetic patients. Journal of telemedicine and telecare, 2023: p. 1357633X231174262. 16. Wilson, M.G., et al., Effect of Intensity and Program Delivery on the Translation of Diabetes Prevention Program to Worksites: A Randomized Controlled Trial of Fuel Your Life. Journal of occupational and environmental medicine, 2016. 58(11): p. 1113-1120.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

The data that support the findings of this study are available from the corresponding author, IRC, upon reasonable request.

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