Effects of a Technology-Assisted Integrated Diabetes Care Program on Cardiometabolic Risk Factors Among Patients With Type 2 Diabetes in the Asia-Pacific Region: The JADE Program Randomized Clinical Trial

Abstract

Importance: Many health care systems lack the efficiency, preparedness, or resources needed to address the increasing number of patients with type 2 diabetes, especially in low- and middle-income countries.

Objective: To examine the effects of a quality improvement intervention comprising information and communications technology and contact with nonphysician personnel on the care and cardiometabolic risk factors of patients with type 2 diabetes in 8 Asia-Pacific countries.

Design, setting, and participants: This 12-month multinational open-label randomized clinical trial was conducted from June 28, 2012, to April 28, 2016, at 50 primary care or hospital-based diabetes centers in 8 Asia-Pacific countries (India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam). Six countries were low and middle income, and 2 countries were high income. The study was conducted in 2 phases; phase 1 enrolled 7537 participants, and phase 2 enrolled 13 297 participants. Participants in both phases were randomized on a 1:1 ratio to intervention or control groups. Data were analyzed by intention to treat and per protocol from July 3, 2019, to July 21, 2020.

Interventions: In both phases, the intervention group received 3 care components: a nurse-led Joint Asia Diabetes Evaluation (JADE) technology-guided structured evaluation, automated personalized reports to encourage patient empowerment, and 2 or more telephone or face-to-face contacts by nurses to increase patient engagement. In phase 1, the control group received the JADE technology-guided structured evaluation and automated personalized reports. In phase 2, the control group received the JADE technology-guided structured evaluation only.

Main outcomes and measures: The primary outcome was the incidence of a composite of diabetes-associated end points, including cardiovascular disease, chronic kidney disease, visual impairment or eye surgery, lower extremity amputation or foot ulcers requiring hospitalization, all-site cancers, and death. The secondary outcomes were the attainment of 2 or more primary diabetes-associated targets (glycated hemoglobin A1c <7.0%, blood pressure <130/80 mm Hg, and low-density lipoprotein cholesterol <100 mg/dL) and/or 2 or more key performance indices (reduction in glycated hemoglobin A1c≥0.5%, reduction in systolic blood pressure ≥5 mm Hg, reduction in low-density lipoprotein cholesterol ≥19 mg/dL, and reduction in body weight ≥3.0%).

Results: A total of 20 834 patients with type 2 diabetes were randomized in phases 1 and 2. In phase 1, 7537 participants (mean [SD] age, 60.0 [11.3] years; 3914 men [51.9%]; 4855 patients [64.4%] from low- and middle-income countries) were randomized, with 3732 patients allocated to the intervention group and 3805 patients allocated to the control group. In phase 2, 13 297 participants (mean [SD] age, 54.0 [11.1] years; 7754 men [58.3%]; 13 297 patients [100%] from low- and middle-income countries) were randomized, with 6645 patients allocated to the intervention group and 6652 patients allocated to the control group. In phase 1, compared with the control group, the intervention group had a similar risk of experiencing any of the primary outcomes (odds ratio [OR], 0.94; 95% CI, 0.74-1.21) but had an increased likelihood of attaining 2 or more primary targets (OR, 1.34; 95% CI, 1.21-1.49) and 2 or more key performance indices (OR, 1.18; 95% CI, 1.04-1.34). In phase 2, the intervention group also had a similar risk of experiencing any of the primary outcomes (OR, 1.02; 95% CI, 0.83-1.25) and had a greater likelihood of attaining 2 or more primary targets (OR, 1.25; 95% CI, 1.14-1.37) and 2 or more key performance indices (OR, 1.50; 95% CI, 1.33-1.68) compared with the control group. For attainment of 2 or more primary targets, larger effects were observed among patients in low- and middle-income countries (OR, 1.50; 95% CI, 1.29-1.74) compared with high-income countries (OR, 1.20; 95% CI, 1.03-1.39) (P = .04).

Conclusions and relevance: In this 12-month clinical trial, the use of information and communications technology and nurses to empower and engage patients did not change the number of clinical events but did reduce cardiometabolic risk factors among patients with type 2 diabetes, especially those in low- and middle-income countries in the Asia-Pacific region.

Trial registration: ClinicalTrials.gov Identifier: NCT01631084.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Lim reported receiving personal fees from Merck Sharp & Dohme during the conduct of the study and grants from AstraZeneca; personal fees from Boehringer Ingelheim, Merck Serono, Novartis, Pfizer, Procter & Gamble Health, and Servier Laboratories; and nonfinancial support from Medtronic, Novo Nordisk, and Sanofi outside the submitted work. Ms Fu reported receiving grants from Merck Sharp & Dohme during the conduct of the study. Dr Ma reported receiving grants from AstraZeneca, Bayer, Merck Sharp & Dohme, Novo Nordisk, and Tricida and personal fees from AstraZeneca and Boehringer Ingelheim outside the submitted work. Ms V. Lau reported receiving grants from Merck Sharp & Dohme during the conduct of the study. Dr Kong reported receiving grants from AstraZeneca and personal fees from Abbott, AstraZeneca, Eli Lilly and Company, and Sanofi outside the submitted work. Dr Chan reported receiving grants from Merck Sharp & Dohme during the conduct of the study; grants from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly and Company, GlaxoSmithKline, Merck Serono, Pfizer, and Sanofi; and personal fees from Bristol Myers Squibb (donated to the Chinese University of Hong Kong, the American Diabetes Association, and other charity organizations to support diabetes research and education) outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram for Phase 1 Study

E1 indicates structured evaluation (standardized data collection, physical assessment, foot and eye examinations, and laboratory measurements) guided by web-based Joint Asia Diabetes Evaluation technology; E2, automated personalized reports to encourage patient empowerment; and E3, 2 or more telephone or face-to-face contacts by nurses to increase patient engagement over a 12-month period.

Figure 2.. CONSORT Diagram for Phase 2 Study

E1 indicates structured evaluation (standardized data collection, physical assessment, foot and eye examinations, and laboratory measurements) guided by web-based Joint Asia Diabetes Evaluation technology; E2, automated personalized reports to encourage patient empowerment; and E3, 2 or more telephone or face-to-face contacts by nurses to increase patient engagement over a 12-month period.

Figure 3.. Effects of Intervention vs Control Conditions on Cardiometabolic Risk Factors Among Participants in Phase 1 Study

To convert low-density lipoprotein (LDL) cholesterol from milligrams per deciliter to millimoles per liter, multiply by 0.0259. HbA1c indicates glycated hemoglobin A1c; BP, blood pressure; OR, odds ratio.

Figure 4.. Effects of Intervention vs Control Conditions on Cardiometabolic Risk Factors Among Participants in Phase 2 Study

To convert low-density lipoprotein (LDL) cholesterol from milligrams per deciliter to millimoles per liter, multiply by 0.0259. HbA1c indicates glycated hemoglobin A1c; BP, blood pressure; OR, odds ratio.