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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes

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

Intervention / Treatment
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* Behavioral: One Drop | Experts On Track
* Behavioral: One Drop | Experts On Call
* Behavioral: One Drop | Experts Revive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T2D: One Drop with Fitbit Ionic<br> | Behavioral: One Drop | Experts On Track<br>* Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months<br>|
| Active Comparator: T2D: One Drop without Fitbit Ionic<br> | Behavioral: One Drop | Experts On Track<br>* Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months<br>|
| No Intervention: T2D: Waitlist Control<br> | |
| Active Comparator: T1D: One Drop with Fitbit Ionic<br> | Behavioral: One Drop | Experts On Call<br>* Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months<br>|
| Active Comparator: T1D: One Drop without Fitbit Ionic<br> | Behavioral: One Drop | Experts On Call<br>* Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months<br>|
| Active Comparator: PD: One Drop with Fitbit Charge 2<br> | Behavioral: One Drop | Experts Revive<br>* Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months<br>|
| Active Comparator: PD: One Drop without Fitbit Charge 2<br> | Behavioral: One Drop | Experts Revive<br>* Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Within- and between-group changes in self-reported weight measured at baseline and follow-up(s). In sub-study 3, the Fitbit Aria Wi-Fi scale will assess weight at baseline, 4, 8, and 12 months post-baseline. | 3 months (12 months for Sub-study 3) | 
| Healthcare Utilization | Within- and between-group change in the number of emergency room visits and hospitalizations. This will be assessed with two self-reported items that ask: (1) How many times have you gone to the emergency room in the past 3 months? and (2) How many times have you been admitted to the hospital in the past 3 months? | 3 months (12 months for Sub-study 3) | 
| Diet | Within- and between-group diet changes. The Summary of Diabetes Self-Care Activities (SDSCA) general and specific diet subscales will measure self-reported 7-day diet behavior at baseline and follow-up(s). The One Drop app will collect daily and weekly diet behavior that's manually entered during the trial period. | 3 months (12 months for Sub-study 3) | 
| Physical Activity | Within- and between-group activity changes. The SDSCA exercise subscale will measure self-reported 7-day exercise behavior at baseline and follow-up(s). The One Drop app will also collect daily and weekly activity that's manually-entered and/or passively-collected via HealthKit, Google Fit, or a Fitbit tracker or smartwatch during the trial period. | 3 months (12 months for Sub-study 3) | 
| Medication Adherence | Within- and between-group medication adherence changes. The SDSCA medications subscale will measure self-reported 7-day medication adherence at baseline and follow-up(s). The One Drop app will also collect daily and weekly medication taking that's manually-entered into the app during the trial period. | 3 months (12 months for Sub-study 3) | 
| Self-Monitoring of Blood Glucose | Within- and between-group self-monitoring of blood glucose (SMBG) changes. The SDSCA SMBG subscale will measure self-reported 7-day SMBG at baseline and follow-up. During the trial period, the One Drop app will collect daily and weekly SMBG that's manually-entered and/or passively-collected via the One Drop | Chrome Bluetooth-connected glucose meter. | 3 months |