JMIR Publications

ABSTRACT

Background:

Medication non-adherence is a significant problem that impacts both the patient, as well as the health system.

Objective:

The objective of this study was to evaluate the impact of a novel smart phone application with patient response directed clinical intervention on medication adherence and blood glucose control in non-insulin dependent T2DM patients

Methods:

We enrolled 50 non-insulin dependent T2DM subjects with smart phones, from a rural health care center in Northern Nevada, for participation in this case-crossover study. Subjects underwent a standard of care arm and an intervention arm. Each study arm was 3 months in duration for a total of 6 months of follow up. Subjects had a hemoglobin A1c (HgbA1c) lab draw at enrollment, 3 months, and 6 months. Subjects had monthly Medication Adherence Scores (MAS) and Self-Efficacy for Appropriate Medication Use Scale (SEAMS) questionnaire completed at baseline and monthly for the duration of the study. Our primary outcomes of interest were the change in hemoglobin A1c between study arms. Secondary outcomes were the evaluation of the in proportion of subjects to achieve a clinically meaningful reduction in A1c and that required escalation of diabetes therapy between study arms. Exploratory outcomes included the analysis of the variation in MPR, MAS, and SEAMS during each study arm.

Results:

30 subjects completed both study arms and were included in the analysis. Dropouts were higher in subjects enrolled in the standard of care arm first (24.0% vs 12.0%). Subjects had a median HbgA1c of 9.1%, had been living with T2DM for 6.0 years, median age of 66 years, and a median of 8.5 medications. HgbA1c reduction was higher during the intervention arm (0.69%, versus 0.35%, p=0.30). More subjects achieved a clinically meaningful reduction in HgbA1c while in the application intervention arm (70.0% versus 40.0%; OR 2.29; 95% CI .94 to 5.6; p=0.09). Subjects had higher odds of a therapy escalation while in the standard of care arm (60.0% versus 16.7%, OR 4.3; 95% CI 1.2 to 15.2; p= 0.021). The median MPR prior to enrollment was 109.0%, 112.0% during the study’s intervention arm, and 102.0% during the standard of care arm. The median Real-time Medication Adherence score was 93.2%. The change in MAS (1.0 versus -0.1) and SEAMS (1.9 versus -0.2) from baseline to month 3 was higher in the intervention arm compared to standard of care.

Conclusions:

A novel smart phone application with patient response directed provider intervention holds promise in the ability to improve blood glucose control in complex non-insulin dependent T2DM and is worthy of additional study. This system of intervention maybe a viable solution to reduce medication burden by being a non-invasive method of reducing the need for diabetes medication escalation. Clinical Trial: 1655381