Diabetes Mellitus, Type 2 Clinical Trial
— Fit-OneOfficial title:
Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Verified date | August 2019 |
Source | Informed Data Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | December 1, 2019 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | One Drop | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Chandra Osborn, PhD, MPH |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health-related Productivity | 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). | 3 months (12 months for Sub-study 3) | |
Other | Health-related Quality of Life | 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). | 3 months (12 months for Sub-study 3) | |
Other | Life Satisfaction | 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). | 3 months (12 months for Sub-study 3) | |
Primary | Hemoglobin A1c | Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months. | 3 months | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 |
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