Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Status unconfirmed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, PreDiabetes
In brief
The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).
Key facts
- Study ID
- NCT03459573
- Run by
- Chandra Osborn, PhD, MPH
- People needed
- 500
- Starts
- 2018-02-23
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2019-08-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-75 years of age
- U.S. residency and mailing address
- Self-reported diagnosis of T1D, T2D, or pre-diabetes
- For people with a diabetes diagnosis, diagnosed for 1+ years
- For people with a diabetes diagnoses, self-reported A1c ≥ 7.0% (later confirmed with a mail-in A1c laboratory test)
- For people with a pre-diabetes diagnoses, self-reported A1c 5.7-6.4% (later confirmed with a mail-in A1c laboratory test)
- For people with T2D or pre-diabetes, BMI ≥ 25
- Owns and uses an iPhone or Android phone
- No cardiovascular problems
- No neuromuscular problems
- No orthopedic problems
- Doctor is ok with increased physical activity
- English-speaking
- Naïve to One Drop's digital therapeutics solution
- Naïve to all Fitbit products
You may not qualify if…
- Currently pregnant or planning to become pregnant during the trial period
- Cannot read or write in English
- Currently in a diabetes education or coaching program
- Previously downloaded the One Drop \| Mobile app
- Owns or previously used Fitbit products
Where it is running
- One Drop — New York, New York, United States
Full record on ClinicalTrials.gov
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