Clinical trial NCT03459573: Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Official title: Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
PreDiabetes
Lead sponsor: Informed Data Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 3 months
Secondary outcomes:
measure: Weight
timeFrame: 3 months (12 months for Sub-study 3)
measure: Healthcare Utilization
timeFrame: 3 months (12 months for Sub-study 3)
measure: Diet
timeFrame: 3 months (12 months for Sub-study 3)
measure: Physical Activity
timeFrame: 3 months (12 months for Sub-study 3)
measure: Medication Adherence
timeFrame: 3 months (12 months for Sub-study 3)
measure: Self-Monitoring of Blood Glucose
timeFrame: 3 months
Other outcomes:
measure: Health-related Productivity
timeFrame: 3 months (12 months for Sub-study 3)
measure: Health-related Quality of Life
timeFrame: 3 months (12 months for Sub-study 3)
measure: Life Satisfaction
timeFrame: 3 months (12 months for Sub-study 3)
Locations:
city: New York
country: United States
facility: One Drop
state: New York
Study officials:
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