The research produced impressive results, but the company acknowledged certain limitations.
Fresh off announcing a new digital weight loss program and a collaboration with Fitbit, One Drop is back in the news this week with mobile study results that claim to validate its technology-based approach to diabetes management.
One Drop makes popular blood glucose monitors that integrate with a mobile app, providing feedback beyond A1c levels. The technology suite allows patients to input their lifestyle information to learn how their choices can impact their blood sugar levels. “People who are able to see the relationship between food, medication, exercise, and glucose will manage their diabetes better,” company CEO Jeff Dachis told Healthcare Analytics News™ in a previous interview.
The new study, published yesterday in JMIR mHealth and uHealth, remotely used inputs from 65 people with type 1 diabetes and 191 people with type 2 diabetes. All patients entered at least two A1c values into the One Drop Mobile app at intervals ranging from 2 to 12 months and had a verified diabetes diagnosis based on their medications.
The company called the results “dramatic.” In a median period of 4 months, patient A1c levels fell by 1.36%. To emphasize the impact a drop like that can have, the study’s accompanying statement cites previous research suggesting that, “Each 1% A1c reduction is associated with a 37% decrease in the risk of microvascular complications and a 21% decrease in the risk of any diabetes-related complication or death.”
The researchers checked the work with 3 mixed-effect repeated measure models to test mean A1c differences, and they applied 4 multiple regression models to test the relationship between self-tracking and A1c change. In both adjusted and unadjusted models, the 1.36% decrease was consistent. In addition, they found that using the One Drop Mobile app to track carbohydrate intake was independently associated with better glucose control.
The study also, however, reports limitations that hinder its generalizability: It was an entirely mobile study conducted using self-reported data. “This is not a randomized controlled trial, preventing causal conclusions,” the authors wrote.
In the end-user license agreement (EULA) that patients accept in order to use the One Drop Mobile app, they agree to grant the company a “perpetual, transferrable, sublicensable, worldwide, nonexclusive, royalty-free license to reproduce, distribute, use, modify, remove, publish, transmit, publicly perform, publicly display, or create derivative works of Your User Content for any purpose without compensation to you, including for the purpose of promoting One Drop and the App.”
Similar wording is becoming standard in user agreements as more health technology companies look to leverage the large swaths of data they can aggregate.
Studying only Apple device users may affect study results for a simple reason: There is an economic and racial breakdown of US smartphone ownership, with the wealthy and white more likely to own iPhones. Income and racial demographics are commonly tied to prevalence and outcomes in chronic disease, and the American Diabetes Association states that minorities are at an elevated risk of diabetes.
“Despite these limitations, people of all ages, race/ethnicities, and socioeconomic backgrounds, increasingly want to use smart devices to assist in the management of diabetes,” the authors write, citing 3 independent studies previously published in JMIR publications. “Research needs to critically evaluate diabetes apps, trackers, and smartwatches, especially as new devices enter the marketplace.”
According to One Drop’s CEO, the app currently has more than 600,000 users and is available in nearly 200 countries. Earlier this month, the company received regulatory approval to launch in Canada.