Drayson Health’s digital remote management app has failed to improve mean blood glucose level in women with gestational diabetes. The primary endpoint miss was the headline detail in a mixed set of data on the GDm-Health app.
Investigators enrolled 203 pregnant women with abnormal glucose tolerance test results. Around half the participants received routine clinical care, while the rest also got access to Drayton’s mobile app. The app is designed to help gestational diabetes patients record their blood glucose levels, send their data to the healthcare system and receive changes to their medication and insulin regimens.
Drayson hoped to show the app improved outcomes by enabling better self-management but the data fell short in some key areas. The app’s inability to drive a change in mean glucose level resulted in the trial missing its primary endpoint and the secondary outcomes were a mixed bag.
Positive findings included statistically significant differences in the numbers of cesarean deliveries and blood glucose readings taken. Patients in the treatment arm also reported statistically higher satisfaction scores. The journal paper published to disclose the data lists the outcomes as secondary endpoints, although not all of them are present on the study’s ClinicalTrials.gov page.
The app failed to move the needle in other regards. Maternal and neonatal outcomes were similar across the treatment and control arms. And the trial linked the app to numerical but not statistical improvements in length of gestation and number of preterm births.
A measure of the effect of the app on healthcare costs also fell short of statistical significance. The researchers calculated the mean cost per delivery in the app arm was around $8,000, compared to more than $9,500 in the control cohort. That finding suggests the app may have an effect on costs, as Drayson’s pitch claims, but leaves the company without a p value to validate the idea.
Drayson is publicly very positive about the trial’s findings and is now planning to use them to support a push to expand access to the app. The company is already offering U.K. healthcare facilities the system on a zero-cost license basis for one year and wants to expand globally.
“Our focus now shifts to working with regulators to make GDm-Health widely available across the U.K. and internationally, helping to improve maternal and neonatal outcomes as prevalence of diabetes in pregnancy continues to increase,” Lord Paul Drayson, the CEO of Drayson Health, said in a statement.