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

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

Sponsors

Lead sponsor: Chandra Osborn, PhD, MPH

Source Informed Data Systems, Inc.
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.

Overall Status Active, not recruiting
Start Date February 23, 2018
Completion Date December 1, 2019
Primary Completion Date August 31, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin A1c 3 months
Secondary Outcome
Measure Time Frame
Weight 3 months (12 months for Sub-study 3)
Healthcare Utilization 3 months (12 months for Sub-study 3)
Diet 3 months (12 months for Sub-study 3)
Physical Activity 3 months (12 months for Sub-study 3)
Medication Adherence 3 months (12 months for Sub-study 3)
Self-Monitoring of Blood Glucose 3 months
Enrollment 500
Condition
Intervention

Intervention type: Behavioral

Intervention name: One Drop | Experts On Track

Description: Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months

Intervention type: Behavioral

Intervention name: One Drop | Experts On Call

Description: Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months

Intervention type: Behavioral

Intervention name: One Drop | Experts Revive

Description: Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Location
facility One Drop
Location Countries

United States

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Informed Data Systems, Inc.

Investigator full name: Chandra Osborn, PhD, MPH

Investigator title: VP, Health & Behavioral Informatics

Has Expanded Access No
Condition Browse
Number Of Arms 7
Arm Group

Arm group label: T2D: One Drop with Fitbit Ionic

Arm group type: Active Comparator

Arm group label: T2D: One Drop without Fitbit Ionic

Arm group type: Active Comparator

Arm group label: T2D: Waitlist Control

Arm group type: No Intervention

Arm group label: T1D: One Drop with Fitbit Ionic

Arm group type: Active Comparator

Arm group label: T1D: One Drop without Fitbit Ionic

Arm group type: Active Comparator

Arm group label: PD: One Drop with Fitbit Charge 2

Arm group type: Active Comparator

Arm group label: PD: One Drop without Fitbit Charge 2

Arm group type: Active Comparator

Acronym Fit-One
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov