This has got to stop

This has got to stop

Read this very carefully;

“In June 2017, we queried data on people with diabetes using the app who had entered at least 2 HbA1c values in the app >60 and ≤365 days apart. Multiple imputation corrected for missing data. Unadjusted and adjusted mixed effects repeated measures models tested mean HbA1c change by time, diabetes type, and their interaction. Multiple regression models assessed relationships between using the app to track food, activity, blood glucose, and medications and HbA1c change.”

We have bolded the most important sentence.

Now look at this:

“One Drop today announced the results of a retrospective study of people with diabetes (type 1 and type 2) using the One Drop | Mobile diabetes management app, demonstrating a 1.1% to 1.3% absolute reduction in A1C in just 4 months. The results were published yesterday, August 24, 2017, in JMIR Diabetes.”

The first statement comes from the study OneDrop mentions in the press release which is where the second statement comes from. The bolded portion states that patients SELF REPORTED their A1c values, these results were NOT INDEPENDTLY verified. We have no idea whether these patients who SELF REPORTED these values had their A1c measured from an actual blood test or did the calculate their own A1c using readings, and if they did how many readings did they use to calculate this value. Perhaps they bought an at home A1c test and used that. Perhaps they used a mail order test. Honestly, we have no way of knowing because the data is SELF REPORTED.

In a REAL clinical trial, we would not worry about such things because it’s a REAL clinical trial. For OneDrop to claim that their system brought about these “improvements” in A1c is horse manure and smells even worse. Making such a claim without any independent verification of the data is just flat out wrong and should not be condoned.

Yet this is what OneDrop and others in this space have done, they played very fast and very loose with the data and seem to be reluctant to put their systems in a REAL clinical trial. They seem to be very reluctant to have anyone INDEPENDENTLY verify results. We are no way claiming that patients lied about their A1c or miscalculated the value or that the test they used was not up to snuff. What we are saying is we would not have to worry about any of this if the results were INDEPENDENTLY verified.

This is like someone doing a triathlon and using their Apple Watch so they can self-report their time. There is a reason each participant gets a timing chip which they wear during the race which is used to determine their OFFICIAL time. For non-triathletes, this like a golfer giving himself a mulligan because he hit the ball out of bounds and did not think he deserved a penalty. Not a triathlete, golfer or even an athlete for that matter this is like a sales person saying he sold around $500,000 of product but does not say he also gave away $450,000 of FREE samples.

Want it even more simple this is complete bullshit and should not be tolerated. This has got to stop. Listen if these systems are as good as the companies claim they are they will stand up and show this under the rigors of a REAL clinical trial. They will stop with this SELF REPORTED crap and have all these results INDEPENDENTLY verified. Enough is enough.