Status:
UNKNOWN
Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Lead Sponsor:
Chandra Osborn, PhD, MPH
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Sub-study 1 (T2D). Eligible participants (N=300) with T2D, an A1c above 7.0% and Body Mass Index (BMI) ≥ 25 will be randomized to one of three groups. Participants assigned to group 1 (n=100) get One ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03459573
Start Date
February 23 2018
End Date
December 1 2019
Last Update
August 9 2019
Active Locations (1)
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1
One Drop
New York, New York, United States, 10002