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

Informed Data Systems

Status: Unknown

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; PreDiabetes

Treatments: Behavioral: One Drop | Experts On Track; Behavioral: One Drop | Experts Revive; Behavioral: One Drop | Experts On Call

Study type: Interventional

Funder types: Industry

Identifiers

NCT03459573

Fit-One

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 7 patient groups

T2D: One Drop with Fitbit Ionic

Active Comparator group

Treatment:

Behavioral: One Drop | Experts On Track

T2D: One Drop without Fitbit Ionic

Active Comparator group

Treatment:

Behavioral: One Drop | Experts On Track

T2D: Waitlist Control

No Intervention group

T1D: One Drop with Fitbit Ionic

Active Comparator group

Treatment:

Behavioral: One Drop | Experts On Call

T1D: One Drop without Fitbit Ionic

Active Comparator group

Treatment:

Behavioral: One Drop | Experts On Call

PD: One Drop with Fitbit Charge 2

Active Comparator group

Treatment:

Behavioral: One Drop | Experts Revive

PD: One Drop without Fitbit Charge 2

Active Comparator group

Treatment:

Behavioral: One Drop | Experts Revive