Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes (Fit-One)
Primary Purpose
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, PreDiabetes
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One Drop | Experts On Track
One Drop | Experts On Call
One Drop | Experts Revive
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 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
Sites / Locations
- One Drop
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Active Comparator
Active Comparator
No Intervention
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
T2D: One Drop with Fitbit Ionic
T2D: One Drop without Fitbit Ionic
T2D: Waitlist Control
T1D: One Drop with Fitbit Ionic
T1D: One Drop without Fitbit Ionic
PD: One Drop with Fitbit Charge 2
PD: One Drop without Fitbit Charge 2
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin A1c
Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.
Secondary Outcome Measures
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.
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?
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.
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.
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.
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.
Full Information
NCT ID
NCT03459573
First Posted
February 20, 2018
Last Updated
August 8, 2019
Sponsor
Chandra Osborn, PhD, MPH
1. Study Identification
Unique Protocol Identification Number
NCT03459573
Brief Title
Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Acronym
Fit-One
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chandra Osborn, PhD, MPH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, PreDiabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T2D: One Drop with Fitbit Ionic
Arm Type
Active Comparator
Arm Title
T2D: One Drop without Fitbit Ionic
Arm Type
Active Comparator
Arm Title
T2D: Waitlist Control
Arm Type
No Intervention
Arm Title
T1D: One Drop with Fitbit Ionic
Arm Type
Active Comparator
Arm Title
T1D: One Drop without Fitbit Ionic
Arm Type
Active Comparator
Arm Title
PD: One Drop with Fitbit Charge 2
Arm Type
Active Comparator
Arm Title
PD: One Drop without Fitbit Charge 2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
One Drop | Experts On Track
Intervention 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(s)
One Drop | Experts On Call
Intervention 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(s)
One Drop | Experts Revive
Intervention Description
Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight
Description
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.
Time Frame
3 months (12 months for Sub-study 3)
Title
Healthcare Utilization
Description
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?
Time Frame
3 months (12 months for Sub-study 3)
Title
Diet
Description
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.
Time Frame
3 months (12 months for Sub-study 3)
Title
Physical Activity
Description
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.
Time Frame
3 months (12 months for Sub-study 3)
Title
Medication Adherence
Description
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.
Time Frame
3 months (12 months for Sub-study 3)
Title
Self-Monitoring of Blood Glucose
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Health-related Productivity
Description
Within- and between-group change in health-related productivity. The Work Productivity and Activity Impairment measure will measure self-reported work productivity (absenteeism, presenteeism and daily activities) at baseline and follow-up(s).
Time Frame
3 months (12 months for Sub-study 3)
Title
Health-related Quality of Life
Description
Within- and between-group change in health-related quality. The CDC HRQOL-14 will measure self-reported health-related quality of life at baseline and follow-up(s).
Time Frame
3 months (12 months for Sub-study 3)
Title
Life Satisfaction
Description
Within- and between-group change in life satisfaction. Cantril's Self-Anchoring Ladder of Life Satisfaction will measure self-reported life satisfaction at baseline and follow-up(s).
Time Frame
3 months (12 months for Sub-study 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
One Drop
City
New York
State/Province
New York
ZIP/Postal Code
10002
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
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