Effectiveness of DialBetesPlus, a self-management support system for diabetic kidney disease: Randomized controlled trial

Abstract

We evaluated the effectiveness of a mobile health (mHealth) intervention for diabetic kidney disease patients by conducting a 12-month randomized controlled trial among 126 type 2 diabetes mellitus patients with moderately increased albuminuria (urinary albumin-to-creatinine ratio (UACR): 30-299 mg/g creatinine) recruited from eight clinical sites in Japan. Using a Theory of Planned Behavior (TPB) behavior change theory framework, the intervention provides patients detailed information in order to improve patient control over exercise and dietary behaviors. In addition to standard care, the intervention group received DialBetesPlus, a self-management support system allowing patients to monitor exercise, blood glucose, diet, blood pressure, and body weight via a smartphone application. The primary outcome, change in UACR after 12 months (used as a surrogate measure of renal function), was 28.8% better than the control group's change (P = 0.029). Secondary outcomes also improved in the intervention group, including a 0.32-point better change in HbA1c percentage (P = 0.041). These improvements persisted when models were adjusted to account for the impacts of coadministration of drugs targeting albuminuria (GLP-1 receptor agonists, SGLT-2 inhibitors, ACE inhibitors, and ARBs) (UACR: -32.3% [95% CI: -49.2%, -9.8%] between-group difference in change, P = 0.008). Exploratory multivariate regression analysis suggests that the improvements were primarily due to levels of exercise. This is the first trial to show that a lifestyle intervention via mHealth achieved a clinically-significant improvement in moderately increased albuminuria.

Fig. 1. CONSORT flow diagram.

After randomization and pre-intervention dropouts, 66 intervention and 60 control patients began the intervention. 62 and 60 remained at 12 months, and 60 and 60 remained at 18 months.

Fig. 2. Effect of intervention on behavior.

a measurement rate of step count b measurement rate of blood glucose c measurement rate of meals d SDSCA score for exercise e SDSCA score for blood glucose monitoring f SDSCA score for diet g difference between intervention and control group of change in SDSCA score for exercise h difference between intervention and control group of change in SDSCA score for blood glucose monitoring i) difference between intervention and control group of change in SDSCA score for diet. Error bars represent 95% confidence interval.

Fig. 3. Effect of intervention on daily step count.

The daily number of steps were averaged over each month of the intervention and all patients in the intervention group, after conservatively eliminating days indicating lack of use of the pedometer (days with fewer than 100 steps recorded, representing 23.7% of patient days.). Error bars represent 95% confidence interval.

Fig. 4. Change in intervention group UACR and HbA1c.

Data is relative to baseline measurements for each patient. a The ratio of UACR to baseline UACR. b The change in HbA1c (in percentage points) relative to baseline HbA1c.

Fig. 5. Summary of DialBetesPlus.

The DialBetesPlus application tracks steps, blood glucose, blood pressure, body weight, additional exercise, and diet. It sends the data to the DialBetesPlus server, where the data is evaluated against guidelines and tailored feedback is provided to the patient through the application. NFC: near field communications. (This figure was published in JMIR Research Protocols (and can be reproduced) under the terms of Creative Commons Attribution 4.0 license).

Fig. 6. Example DialBetesPlus Feedback.

Users receive feedback on steps, blood glucose, blood pressure, body weight, additional exercise, and diet.