Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
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).
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 Drop's digital therapeutics solution (app, meter, and 'On Track' in-app
coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants
assigned to group 2 (n=100) get One Drop's digital therapeutics solution and are asked to use
it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Finally,
participants assigned to group 3 (n=100) are asked to manage their diabetes without an app,
coach, or activity tracker for 3 months. After 3 months, group 3 gets One Drop's digital
therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic
smartwatch (n=100).
Sub-study 2 (T1D). Eligible participants (N=100) with T1D and an A1c above 7.0% will be
randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's
digital therapeutics solution (app, meter, and 'On Call' in-app coaching) and a Fitbit Ionic
smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=50)
get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3
months, group 2 gets a Fitbit Ionic smartwatch.
Sub-study 3 (Pre-diabetes). Eligible participants (N=100) with pre-diabetes, an A1c between
5.7-6.4% and a BMI ≥ 25 will be randomized to one of two groups. Participants assigned to
group 1 (n=50) get One Drop's digital therapeutics solution ('Revive' in-app coaching) and a
Fitbit Charge 2 and are asked to use both for 3 months. Participants assigned to group 2
(n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months.
After 3 months, group 2 gets a Fitbit Charge 2.
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