Putting One Drop and Fitbit to the Test – Can They Lower A1C and Improve Productivity?

By Amelia Dmowska

A study testing whether One Drop’s coaching app, along with Fitbit activity trackers, can help people with diabetes and prediabetes meet their goals

Clinical Trials Identifier: NCT03459573

Trial Name: Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes (Fit-One)

Diabetes type: Type 1 diabetes, type 2 diabetes, and prediabetes

What the trial is testing: This trial will test the impact of combining One Drop, a mobile diabetes app and coaching service, with wearable Fitbit devices for activity tracking. Participants will have access to a Fitbit activity tracker and the One Drop coaching app for free. The study includes people with diabetes (type 1 and type 2) and prediabetes, with the primary aim of reducing A1C over three months. The One Drop app allows users to log food, exercise, and medication; track blood sugar levels through a connected glucose meter; and receive personal coaching and education. Study participants will also wear a Fitbit activity tracker (Ionic smartwatch or Charge 2), which are now integrated with the One Drop app, to track their activity, sleep patterns, and heart rate.

What the trial is measuring: The study will track the following: change in weight, the number of emergency room visits and hospitalizations, changes in diet, exercise behavior, medication adherence, and blood sugar monitoring frequency. Participants will also be asked about any changes in their productivity at work and in daily activities, health-related quality of life, and general life satisfaction. People who enroll in the study will be divided into “sub-studies” depending on diabetes type – type 2 diabetes, type 1 diabetes, and prediabetes – to analyze One Drop’s diabetes-specific in-app coaching programs.

Why is this important?

Studies testing the impact of digital diabetes tools, data, and coaching are rare – especially in a broad population of people with type 1, type 2, and prediabetes. If this study can show positive outcomes, it will help validate that these tools actually work. Moreover, if One Drop and Fitbit tools can actually reduce healthcare costs and even dangerous hospitalizations, these study results could help in discussions with insurance companies, employers, and even governments.

Trial length: The trial will last 3 months for participants with type 1 diabetes and type 2 diabetes. Participants with prediabetes will also have follow-ups at 4, 8, and 12 months following a three month-enrollment in the study.  

Trial locations: This study will enroll about 500 participants in New York, NY.   

Do you qualify? Select criteria include:

• Between 18-75 years old

• United States residency

• Self-reported diagnosis of T1D or T2D (over a year ago), or pre-diabetes

• For people with a diabetes diagnosis, self-reported A1C ≥ 7.0% (later confirmed with a mail-in A1C laboratory test)

• For people with a prediabetes diagnosis, self-reported A1C 5.7-6.4% (later confirmed with a mail-in A1C laboratory test)

• For people with type 2 diabetes or prediabetes, a body mass index (BMI) of at least 25 (click here for a BMI calculator)

• Owns and uses an iPhone or Android phone

• No cardiovascular, neuromuscular, or orthopedic problems

• Speaks English

• Has not used One Drop or Fitbit before

• Not currently pregnant or planning to become pregnant during the trial period

• Not currently in a diabetes education or coaching program

Click here for the full list of inclusion and exclusion criteria.

Where to get more information: For more information about this trial, see this clinical trial page or contact Dr. Chandra Osborn, by calling 860-424-2858 or emailing  chandra@onedrop.today.