Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial

Abstract

Background: A mobile phone-based application can be useful for patients with type 1 diabetes in managing their disease. This results in large datasets accumulated on the patient's devices, which can be used for individualized feedback. The effect of such feedback is investigated in this article.

Materials and methods: We developed an application that included a data-driven feedback module known as Diastat for patients on self-measured blood glucose regimens. Using a stepped-wedge design, both groups initially received an application without Diastat. Group 1 activated Diastat after 4 weeks, whereas Group 2 activated Diastat 12 weeks after startup (T1). End points were glycated hemoglobin (HbA1c) level and number of out-of-range (OOR) measurements (i.e., outside the range 72-270 mg/dL).

Results: Thirty patients were recruited to the study, and 15 were assigned to each group after the initial meeting. There were no significant differences between groups at T1 in HbA1c or OOR events. Overall, all patients had a decrease of 0.6 percentage points in mean HbA1c (P < 0.001) and 14.5 in median OOR events over 2 weeks (P < 0.001).

Conclusions: The study does not provide evidence that data-driven feedback improves glycemic control. The decrease in HbA1c was sizeable and significant, even though the study was not powered to detect this. The overall improvement in glycemic control suggests that, in general, mobile phone-based interventions can be useful in diabetes self-management.

Trial registration: ClinicalTrials.gov NCT01774149.

Figures

FIG. 1.

Screenshots of components of the Diabetes Diary with the Diastat module installed: (left panel) the main page of the diary; (upper middle panel) periodicity graph over 24 h; (upper right panel) periodicity graph over 1 week; (lower middle panel) trend display showing one short-term increasing trend and one longer-term decreasing trend; and (lower right panel) situation matching, where the top section shows the best matched situations to the current and the lower section shows the chosen situation in context. Color images available online at www.liebertonline.com/dia

FIG. 2.

Flowchart. Vertical lines indicate physical meetings with adjacent numbers indicating number of patients met. Dashed lines are meetings where the Diabetes Diary was deployed. Shaded areas indicate periods where registrations are used for calculations of out-of-range measurements. White numbers are active patients (i.e., who had sufficient recordings for analysis in the period). Numbers in parentheses are how many met for glycated hemoglobin (HbA1c) measurements. Dates shown are those used for analysis and when the majority of the patients met. Because of practical considerations not all patients were able to meet on the day indicated, but they did meet on dates as close as possible. Randomization was done immediately after the initial meeting.

FIG. 3.

Changes in primary end point and glycated hemoglobin (HbA1c) level over the study: (left panel) HbA1c and (right panel) number of measurements outside the optimal range (out of range). Each line shows one eligible patient. Mean (left panel) and median (right panel) values are shown as diamonds for each time period and group.