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

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.

Inclusion Criteria:

- 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 Criteria:

- 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