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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03459573
• Other study ID #: Fit-One
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2019
• Source: Informed Data Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	One Drop	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Chandra Osborn, PhD, MPH

Country where clinical trial is conducted

United States, 

References & Publications (13)

Baye E, Menon K, de Courten MP, Earnest A, Cameron J, de Courten B. Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2017 Sep 1;7(9):e017691. doi: 10.1136/bmjopen-2017-017691. — View Citation

Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10. — View Citation

Coughlin SS, Hatzigeorgiou C, Anglin J, Xie D, Besenyi GM, De Leo G, Stewart J, Wilkins T. Healthy lifestyle intervention for adult clinic patients with type 2 diabetes mellitus. Diabetes Manag (Lond). 2017;7(2):197-204. — View Citation

Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. — View Citation

Diaz KM, Krupka DJ, Chang MJ, Peacock J, Ma Y, Goldsmith J, Schwartz JE, Davidson KW. Fitbit®: An accurate and reliable device for wireless physical activity tracking. Int J Cardiol. 2015 Apr 15;185:138-40. doi: 10.1016/j.ijcard.2015.03.038. Epub 2015 Mar 4. — View Citation

Gow ML, Baur LA, Johnson NA, Cowell CT, Garnett SP. Reversal of type 2 diabetes in youth who adhere to a very-low-energy diet: a pilot study. Diabetologia. 2017 Mar;60(3):406-415. doi: 10.1007/s00125-016-4163-5. Epub 2016 Nov 26. — View Citation

Green AJ, Bazata DD, Fox KM, Grandy S; SHIELD Study Group. Health-related behaviours of people with diabetes and those with cardiometabolic risk factors: results from SHIELD. Int J Clin Pract. 2007 Nov;61(11):1791-7. Epub 2007 Sep 20. — View Citation

Herman WH, Rothberg AE. Prevalence of Diabetes in the United States: A Glimmer of Hope? JAMA. 2015 Sep 8;314(10):1005-7. doi: 10.1001/jama.2015.10030. — View Citation

Krass I, Schieback P, Dhippayom T. Adherence to diabetes medication: a systematic review. Diabet Med. 2015 Jun;32(6):725-37. doi: 10.1111/dme.12651. Epub 2015 Jan 9. Review. — View Citation

Marathe PH, Gao HX, Close KL. American Diabetes Association Standards of Medical Care in Diabetes 2017. J Diabetes. 2017 Apr;9(4):320-324. doi: 10.1111/1753-0407.12524. — View Citation

Peyrot M, Rubin RR, Lauritzen T, Snoek FJ, Matthews DR, Skovlund SE. Psychosocial problems and barriers to improved diabetes management: results of the Cross-National Diabetes Attitudes, Wishes and Needs (DAWN) Study. Diabet Med. 2005 Oct;22(10):1379-85. — View Citation

Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. — View Citation

Vangeepuram N, Williams N, Constable J, Waldman L, Lopez-Belin P, Phelps-Waldropt L, Horowitz CR. TEEN HEED: Design of a clinical-community youth diabetes prevention intervention. Contemp Clin Trials. 2017 Jun;57:23-28. doi: 10.1016/j.cct.2017.03.010. Epub 2017 Mar 23. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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