Effectiveness of DialBetesPlus, a self-management support system for diabetic kidney disease: Randomized controlled trial
Magliano D. J., Boyko E. J. IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th ed. Brussels: International Diabetes Federation; 2021.
Gülümsek, E. Keşkek ŞÖ. Direct medical cost of nephropathy in patients with type 2 diabetes. Int Urol. Nephrol. 54, 1383–1389 (2022).
Google Scholar
Koye, D. N. et al. The global epidemiology of diabetes and kidney disease. Adv. Chronic Kidney Dis. 25, 121–132 (2018).
Google Scholar
Tofte, N. et al. Early detection of diabetic kidney disease by urinary proteomics and subsequent intervention with spironolactone to delay progression (PRIORITY): a prospective observational study and embedded randomised placebo-controlled trial. Lancet Diabetes Endocrinol. 8, 301–312 (2020).
Google Scholar
Coresh, J. et al. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies. Lancet Diabetes Endocrinol. 7, 115–127 (2019).
Google Scholar
Heerspink, H. J. L. et al. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials. Lancet Diabetes Endocrinol. 7, 128–139 (2019).
Google Scholar
Penno, G. et al. Independent correlates of urinary albumin excretion within the normoalbuminuric range in patients with type 2 diabetes: The Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicentre Study. Acta Diabetol. 52, 971–981 (2015).
Google Scholar
Persson, F. et al. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial. Diabetes Care 44, 1020–1026 (2021).
Google Scholar
Levey, A. S. et al. Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of CKD: A Scientific Workshop Sponsored by the National Kidney Foundation in Collaboration With the US Food and Drug Administration and European Medicines Agency. Am. J. Kidney Dis. 75, 84–104 (2020).
Google Scholar
Mendonça, L. et al. Characterizing palliative care needs in people with or at risk of developing diabetic foot ulcers. Ther. Adv. Endocrinol. Metab. 13, 20420188221136770 (2022).
Google Scholar
Stevens, P. E. & Levin, A. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann. Intern. Med. 158, 825–830 (2013).
Google Scholar
Eckardt, K. U. et al. Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 93, 1281–1292 (2018).
Google Scholar
Guideline development group. Clinical Practice Guideline on management of patients with diabetes and chronic kidney disease stage 3b or higher (eGFR <45 mL/min). Nephrol. Dial. Transpl. 30, ii1–ii142 (2015).
Google Scholar
Onyenwenyi, C. & Ricardo, A. C. Impact of lifestyle modification on diabetic kidney disease. Curr. Diab Rep. 15, 60 (2015).
Google Scholar
Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of Diabetes on the development and progression of long-term Complications in insulin-dependent Diabetes Mellitus. N. Engl. J. Med. 329, 977–986 (1993).
Google Scholar
Stratton, I. M. et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321, 405–412 (2000).
Google Scholar
Amaral, L. S. B., Souza, C. S., Lima, H. N. & Soares, T. J. Influence of exercise training on diabetic kidney disease: a brief physiological approach. Exp. Biol. Med. 245, 1142–1154 (2020).
Google Scholar
Sheshadri, A. et al. Structured moderate exercise and biomarkers of kidney health in sedentary older adults: the lifestyle interventions and independence for elders randomized clinical trial. Kidney Med. 5, 100721 (2023).
Google Scholar
Dong, L. et al. Long-term intensive lifestyle intervention promotes improvement of stage III diabetic nephropathy. Med Sci. Monit. 25, 3061–3068 (2019).
Google Scholar
Cui, M. et al. T2DM self-management via smartphone applications: a systematic review and meta-analysis. PLoS ONE 11, e0166718 (2016).
Google Scholar
Greenwood, D. A. et al. A systematic review of reviews evaluating technology-enabled diabetes self-management education and support. J. Diabetes Sci. Technol. 11, 1015–1027 (2017).
Google Scholar
Changizi, M. & Kaveh, M. H. Effectiveness of the mHealth technology in improvement of healthy behaviors in an elderly population-a systematic review. Mhealth 3, 51 (2017).
Google Scholar
Waki, K. et al. DialBetics: A Novel Smartphone-based Self-management Support System for Type 2 Diabetes Patients. J. Diabetes Sci. Technol. 8, 209–215 (2014).
Google Scholar
Bhalla, V. et al. Racial/ethnic differences in the prevalence of proteinuric and nonproteinuric diabetic kidney disease. Diabetes Care 36, 1215–1221 (2013).
Google Scholar
Cai, Z., Yang, Y. & Zhang, J. Effects of physical activity on the progression of diabetic nephropathy: a meta-analysis. Biosci. Rep. 41, BSR20203624 (2021).
Google Scholar
Lazarevic, G. et al. Effects of aerobic exercise on microalbuminuria and enzymuria in type 2 diabetic patients. Ren. Fail 29, 199–205 (2007).
Google Scholar
Hellberg, M. et al. Randomized controlled trial of exercise in CKD-The RENEXC study. Kidney Int. Rep. 4, 963–976 (2019).
Google Scholar
Sokolovska, J. et al. Impact of interval walking training managed through smart mobile devices on albuminuria and leptin/adiponectin ratio in patients with type 2 diabetes. Physiol. Rep. 8, e14506 (2020).
Google Scholar
Yamamoto-Kabasawa, K. et al. Benefits of a 12-week lifestyle modification program including diet and combined aerobic and resistance exercise on albuminuria in diabetic and non-diabetic Japanese populations. Clin. Exp. Nephrol. 19, 1079–1089 (2015).
Google Scholar
Mann, J. F. E. et al. Liraglutide and renal outcomes in Type 2 diabetes. N. Engl. J. Med. 377, 839–848 (2017).
Google Scholar
von Scholten, B. J. et al. The effect of liraglutide on renal function: a randomized clinical trial. Diabetes Obes. Metab. 19, 239–247 (2017).
Google Scholar
Muskiet, M. H. A. et al. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 6, 859–869 (2018).
Google Scholar
Tuttle, K. R. et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 6, 605–617 (2018).
Google Scholar
Chetty, V. T. et al. The effect of continuous subcutaneous glucose monitoring (CGMS) versus intermittent whole blood finger-stick glucose monitoring (SBGM) on hemoglobin A1c (HBA1c) levels in Type I diabetic patients: a systematic review. Diabetes Res Clin. Pr. 81, 79–87 (2008).
Google Scholar
Spring, B. et al. Multicomponent mHealth intervention for large, sustained change in multiple diet and activity risk behaviors: the make better choices 2 randomized controlled trial. J. Med. Internet Res. 20, e10528 (2018).
Google Scholar
Chawla, N. V. & Davis, D. A. Bringing big data to personalized healthcare: a patient-centered framework. J. Gen. Intern. Med. 28, S660–S665 (2013).
Google Scholar
Jakob, R. et al. Factors influencing adherence to mHealth apps for prevention or management of noncommunicable diseases: systematic review. J. Med. Internet Res. 24, e35371 (2022).
Google Scholar
Shaw, K. A., Gennat, H. C., O’Rourke, P. eds. Exercise for overweight or obesity. Cochrane Database of Systematic Reviews, (4), John Wiley & Sons, Ltd; 2006.
Câmara, N. O. et al. Kidney disease and obesity: epidemiology, mechanisms and treatment. Nat. Rev. Nephrol. 13, 181–190 (2017).
Google Scholar
Navaneethan, S. D. et al. Urinary albumin excretion, HMW adiponectin, and insulin sensitivity in type 2 diabetic patients undergoing bariatric surgery. Obes. Surg. 20, 308–315 (2010).
Google Scholar
Tudor-Locke, C. et al. Accelerometer steps/day translation of moderate-to-vigorous activity. Prev. Med. 53, 31–33 (2011).
Google Scholar
Del Pozo Cruz, B. et al. How many steps a day to reduce the risk of all-cause mortality? A dose-response meta-analysis. J. Intern. Med. 291, 519–521 (2022).
Google Scholar
Lee, I. M. et al. Association of step volume and intensity with all-cause mortality in older women. JAMA Intern. Med, 179, 1105–1112 (2019).
Google Scholar
Bull, F. C. et al. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br. J. Sports Med. 54, 1451–1462 (2020).
Google Scholar
Rossing, P. & Epstein, M. Microalbuminuria constitutes a clinical action item for clinicians in 2021. Am. J. Med. 135, 576–580 (2022).
Google Scholar
Shlipak, M. G. et al. The case for early identification and intervention of chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 99, 34–47 (2021).
Google Scholar
Minutolo, R. et al. Cardiorenal prognosis by residual proteinuria level in diabetic chronic kidney disease: pooled analysis of four cohort studies. Nephrol. Dial. Transpl. 33, 1942–1949 (2018).
Google Scholar
Lambers Heerspink, H. J. et al. Albuminuria assessed from first-morning-void urine samples versus 24-hour urine collections as a predictor of cardiovascular morbidity and mortality. Am. J. Epidemiol. 168, 897–905 (2008).
Google Scholar
Ang, I. Y. H. et al. A Personalized Mobile Health Program for Type 2 Diabetes During the COVID-19 Pandemic: Single-Group Pre–Post Study. JMIR Diabetes 6, e25820 (2021).
Google Scholar
Riangkam, C. et al. Effects of a mobile health diabetes self-management program on HbA1C, self-management and patient satisfaction in adults with uncontrolled type 2 diabetes: a randomized controlled trial. J. Health Res. 36, 878–888 (2022).
Google Scholar
Kawai, Y. et al. Efficacy of the Self-management Support System DialBetesPlus for Diabetic Kidney Disease: Protocol for a Randomized Controlled Trial. JMIR Res. Protoc. 10, e31061 (2021). https://www.researchprotocols.org/2021/8/e31061.
Menon, S. M. & Zink, R. C. Modern Approaches to Clinical Trials Using SAS : Classical, Adaptive, and Bayesian Methods. SAS Institute Inc., 2015.
Ajzen, I. & Schmidt, P. Changing Behavior using the Theory of Planned Behavior. In: Hagger, M., Cameron, L., Hamilton, K., Hankonen, N. & Lintunen T. eds. The Handbook of Behavior Change. Cambridge University Press. 2020:chap 2.
Leehey, D. J. et al. Aerobic exercise in obese diabetic patients with chronic kidney disease: a randomized and controlled pilot study. Cardiovasc. Diabetol. 8, 62 (2009).
Google Scholar
Straznicky, N. E. et al. Exercise augments weight loss induced improvement in renal function in obese metabolic syndrome individuals. J. Hypertens. 29, 553–564 (2011).
Google Scholar
Jakobsen, J. C. et al. When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med. Res. Methodol. 17, 162 (2017).
Google Scholar
Graham, J. W. Missing data analysis: making it work in the real world. Annu. Rev. Psychol. 60, 549–576 (2009).
Google Scholar
Hair, J. F. Jr., Black, W. C., Babin, B. J. eds. Multivariate Data Analysis. 7th ed. Pearson Education Ltd; 2010.
James, G., Witten, D., Hastie, T. eds. An introduction to statistical learning: Springer; 2013.
Trevor, H., Robert, T. & Ryan, T. Best Subset, Forward Stepwise or Lasso? Analysis and Recommendations Based on Extensive Comparisons. Statist. Sci. 35, 579–592 (2020).
Bassett, D. R. et al. Pedometermeasured physical activity and health behaviors in United States adults. Med. Sci. Sport Exerc. 42, 1819–1825 (2011).
Google Scholar
link
