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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459573
Recruitment Status : Active, not recruiting
First Posted : March 9, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Chandra Osborn, PhD, MPH, 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 PreDiabetes Behavioral: One Drop | Experts On Track Behavioral: One Drop | Experts On Call Behavioral: One Drop | Experts Revive Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Actual Study Start Date : February 23, 2018
Actual Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Active Comparator: T2D: One Drop with Fitbit Ionic Behavioral: One Drop | Experts On Track
Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months

Active Comparator: T2D: One Drop without Fitbit Ionic Behavioral: One Drop | Experts On Track
Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months

No Intervention: T2D: Waitlist Control
Active Comparator: T1D: One Drop with Fitbit Ionic Behavioral: One Drop | Experts On Call
Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months

Active Comparator: T1D: One Drop without Fitbit Ionic Behavioral: One Drop | Experts On Call
Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months

Active Comparator: PD: One Drop with Fitbit Charge 2 Behavioral: One Drop | Experts Revive
Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months

Active Comparator: PD: One Drop without Fitbit Charge 2 Behavioral: One Drop | Experts Revive
Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 3 months ]
    Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.


Secondary Outcome Measures :
  1. Weight [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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.

  2. Healthcare Utilization [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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. Diet [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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.

  4. Physical Activity [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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.

  5. Medication Adherence [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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.

  6. Self-Monitoring of Blood Glucose [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Health-related Productivity [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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).

  2. Health-related Quality of Life [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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. Life Satisfaction [ Time Frame: 3 months (12 months for Sub-study 3) ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459573


Locations
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United States, New York
One Drop
New York, New York, United States, 10002
Sponsors and Collaborators
Chandra Osborn, PhD, MPH
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chandra Osborn, PhD, MPH, VP, Health & Behavioral Informatics, Informed Data Systems, Inc.
ClinicalTrials.gov Identifier: NCT03459573    
Other Study ID Numbers: Fit-One
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases