Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
NCT ID: NCT03459573
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2018-02-23
2019-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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T2D: One Drop with Fitbit Ionic
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
T2D: One Drop without Fitbit Ionic
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
T2D: Waitlist Control
No interventions assigned to this group
T1D: One Drop with Fitbit Ionic
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
T1D: One Drop without Fitbit Ionic
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
PD: One Drop with Fitbit Charge 2
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
PD: One Drop without Fitbit Charge 2
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Chandra Osborn, PhD, MPH
INDUSTRY
Responsible Party
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Chandra Osborn, PhD, MPH
VP, Health & Behavioral Informatics
Locations
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One Drop
New York, New York, United States
Countries
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References
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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. No abstract available.
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-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. doi: 10.1056/NEJM200105033441801.
Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
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. No abstract available.
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.
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. doi: 10.1111/j.1742-1241.2007.01588.x. Epub 2007 Sep 20.
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. doi: 10.1111/j.1464-5491.2005.01644.x.
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.
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. No abstract available.
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.
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.
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.
Diaz KM, Krupka DJ, Chang MJ, Peacock J, Ma Y, Goldsmith J, Schwartz JE, Davidson KW. Fitbit(R): 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. No abstract available.
Osborn CY, Hirsch A, Sears LE, Heyman M, Raymond J, Huddleston B, Dachis J. One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Sep 17;8(9):e16745. doi: 10.2196/16745.
Other Identifiers
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Fit-One
Identifier Type: -
Identifier Source: org_study_id
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