Improving HbA1c with Glucose Self-Monitoring in Diabetic Patients with EpxDiabetes, a Phone Call and Text Message-Based Telemedicine Platform: A Randomized Controlled Trial

Abstract

Background:We conducted a randomized controlled trial of EpxDiabetes, a novel digital health intervention as an adjunct therapy to reduce HbA_1c and fasting blood glucose (FBG) among patients with type 2 diabetes mellitus (T2DM). In addition, we examined the effect of social determinants of health on our system.Methods:Sixty-five (n = 65) patients were randomized at a primary care clinic. Self-reported FBG data were collected by EpxDiabetes automated phone calls or text messages. Only intervention group responses were shared with providers, facilitating follow-up and bidirectional communication. ΔHbA_1c and ΔFBG were analyzed after 6 months.Results:There was an absolute HbA_1c reduction of 0.69% in the intervention group (95% confidence interval [CI], -1.41 to 0.02) and an absolute reduction of 0.03% in the control group (95% CI, -0.88 to 0.82). For those with baseline HbA_1c >8%, HbA_1c decreased significantly by 1.17% in the intervention group (95% CI, -1.90 to -0.44), and decreased by 0.02% in the control group (95% CI, -0.99 to 0.94). FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69). Engagement (proportion responding to ≥25% of texts or calls over 4 weeks) was 58% for the intervention group (95% CI, 0.373-0.627) and 48% for the control group (95% CI, 0.296-0.621). Smoking, number of comorbidities, and response rate were significant predictors of ΔHbA_1c.Conclusions:EpxDiabetes helps to reduce HbA_1c in patients with uncontrolled T2DM and fosters patient-provider communication; it has definite merit as an adjunct therapy in diabetes management. Future work will focus on improving the acceptability of the system and implementation on a larger scale trial.

Keywords: diabetes; digital health; e-health; glycemic control; self-monitoring; telemedicine.

Fig. 1.

CONSORT diagram. Color images are available online.

Fig. 2.

EpxDiabetes intervention design and Alert protocol. Adapted from Peters et al., a concomitant quality improvement trial using EpxDiabetes.

Fig. 3.

Comparison of intervention and control group ΔHbA1_c after 6 months.

Fig. 4.

Distribution of the intervention and control groups across HbA1_c values and FBG values from baseline to posttrial. FBG, fasting blood glucose. Color images are available online.

Fig. 5.

The average response rates and average engagement rates for each month of intervention. Standard error bars are displayed. *Response rates were significantly different during months 5 and 6. Color images are available online.