Effect of a Web-Based Management Guide on Risk Factors in Patients With Type 2 Diabetes and Diabetic Kidney Disease: A JADE Randomized Clinical Trial

Abstract

Importance: Diabetic kidney disease (DKD) and its comorbidities can be prevented by treating multiple targets. Technology-assisted team-based care with regular feedback and patient empowerment can improve the attainment of multiple targets and clinical outcomes in patients with type 2 diabetes, but the effects of this intervention on patients with DKD are unclear.

Objective: To evaluate the effect of the Joint Asia Diabetes Evaluation (JADE) web portal, nurse reminders, and team-based care on multiple risk factors in patients with DKD.

Design, setting, and participants: This 12-month multinational, open-label randomized clinical trial was conducted between June 27, 2014, and February 19, 2019, at 13 hospital-based diabetes centers in 8 countries or regions in Asia. All patients who participated had DKD. The intention-to-treat data analysis was performed from April 7 to June 30, 2020.

Interventions: Patients were randomized in a 1:1:1 ratio at each site to usual care, empowered care, or team-based empowered care. All patients underwent a JADE web portal-guided structured assessment at baseline and month 12. Patients in the usual care and empowered care groups received a medical follow-up. Patients in the empowered care group also received a personalized JADE report and nurse telephone calls every 3 months. Patients in the team-based empowered care group received additional face-to-face reviews every 3 months from a physician-nurse team.

Main outcomes and measures: The primary outcome was the proportion of patients who attained multiple treatment targets (defined as ≥3 of 5 targets: HbA1c level <7.0% [53 mmol/mol], blood pressure <130/80 mm Hg, low-density lipoprotein cholesterol level <1.8 mmol/L, triglyceride level <1.7 mmol/L, and/or persistent use of renin-angiotensin-aldosterone system inhibitors).

Results: A total of 2393 patients (mean [SD] age, 67.7 [9.8] years; 1267 men [52.9%]) were randomized to the usual care group (n = 795), empowered care group (n = 802), and team-based empowered care group (n = 796). At baseline, 34.7% patients (n = 830) were on 3 treatment targets. On intention-to-treat analysis, the team-based empowered care group had the highest proportion of patients who had further increase in attainment of multiple treatment targets (within-group differences: usual care group, 3.9% [95% CI, 0.0%-7.8%]; empowered care group, 1.3% [95% CI, -2.8% to 5.4%]; team-based empowered care group, 9.1% [95% CI, 4.7%-13.5%]). The team-based empowered care group was more likely to attain multiple treatment targets than the usual care group (risk ratio [RR], 1.17; 95% CI, 1.00-1.37) and the empowered care group (RR, 1.25; 95% CI, 1.06-1.48) after adjustment for site. Compared with the group that did not attain multiple treatment targets, the group that attained multiple treatment targets reported a lower incidence of cardiovascular, kidney, and cancer events (8.4% [n = 51] vs 14.5% [n = 134]; P = .004). Analysis of the per-protocol population yielded similar results.

Conclusions and relevance: This trial found that technology-assisted team-based care for 12 months improved the attainment of multiple treatment targets as well as empowerment in patients with DKD.

Trial registration: ClinicalTrials.gov Identifier: NCT02176278.

Conflict of interest statement

Conflict of Interest Disclosures: Professor Chan reported serving as a board member and pro bono chief executive officer from Asia Diabetes Foundation; receiving grants from AstraZeneca, Bayer, Boehringer Ingelheim, Hua Medicine, Lee Powder, Lilly, Merck, Merck Sharp & Dohme (MSD), Pfizer, Roche, and Sanofi; holding a licensed patent for use of biomarkers to identify individuals at increased risk of diabetic kidney disease; being cofounder of GemVCare; and personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Merck, MSD, Pfizer, Roche, and Sanofi during the conduct of the study. Dr Nguyen reported receiving personal fees as chair of scientific meeting from NovoNordisk, Boehringer Ingelheim, Servier, Abbott, and MSD outside the submitted work. Professor Chia reported receiving grants from MSD during the conduct of the study. Professor Ma reported receiving other for clinical trials, consultancy, or lectures from AstraZeneca, Bayer, MSD, Novo Nordisk, Sanofi, Tricida Inc, and Boehringer Ingelheim; holding a licensed patent for use of biomarkers to identify individuals at increased risk of diabetic kidney disease; and being the cofounder of the technology start-up GemVCare. Professor Chow reported receiving personal fees from Sanofi and grants from Medtronic Diabetes outside the submitted work. Dr Lim reported receiving grants from AstraZeneca and Boehringer Ingelheim; personal fees from MSD, Novo Nordisk, Procter & Gamble Health, and Servier; and nonfinancial support from Pfizer and Sanofi outside the submitted work. Dr Luk reported receiving other for clinical trials or lectures from Boehringer Ingelheim, Eli Lilly, MSD, Amgen, Bayer, Lee's Pharmaceutical, Novo Nordisk, and Sugardown Ltd outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. CONSORT Study Flow Diagram

The number of patients in the per-protocol population might not add up because some patients were excluded from the per-protocol analysis.

Figure 2.. Changes in the Proportion of Patients Attaining at Least 3 Treatment Targets at Study End in the Intention-to-Treat Population

The McNemar test was used for within-group and χ2 test for between-group comparisons of categorical variables. The within-group differences were 3.9% (95% CI, 0.0%-7.8%) in the usual care group, 1.3% (95% CI, −2.8% to 5.4%) in the empowered care group, and 9.1% (95% CI, 4.7%-13.5%) in the team-based empowered care group.