NCT03459573

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

February 20, 2018

Last Update Submit

August 8, 2019

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1PreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.

    3 months

Secondary Outcomes (6)

  • Weight

    3 months (12 months for Sub-study 3)

  • Healthcare Utilization

    3 months (12 months for Sub-study 3)

  • Diet

    3 months (12 months for Sub-study 3)

  • Physical Activity

    3 months (12 months for Sub-study 3)

  • Medication Adherence

    3 months (12 months for Sub-study 3)

  • +1 more secondary outcomes

Other Outcomes (3)

  • Health-related Productivity

    3 months (12 months for Sub-study 3)

  • Health-related Quality of Life

    3 months (12 months for Sub-study 3)

  • Life Satisfaction

    3 months (12 months for Sub-study 3)

Study Arms (7)

T2D: One Drop with Fitbit Ionic

ACTIVE COMPARATOR
Behavioral: One Drop | Experts On Track

T2D: One Drop without Fitbit Ionic

ACTIVE COMPARATOR
Behavioral: One Drop | Experts On Track

T2D: Waitlist Control

NO INTERVENTION

T1D: One Drop with Fitbit Ionic

ACTIVE COMPARATOR
Behavioral: One Drop | Experts On Call

T1D: One Drop without Fitbit Ionic

ACTIVE COMPARATOR
Behavioral: One Drop | Experts On Call

PD: One Drop with Fitbit Charge 2

ACTIVE COMPARATOR
Behavioral: One Drop | Experts Revive

PD: One Drop without Fitbit Charge 2

ACTIVE COMPARATOR
Behavioral: One Drop | Experts Revive

Interventions

One Drop | Experts On TrackBEHAVIORAL

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 with Fitbit IonicT2D: One Drop without Fitbit Ionic
One Drop | Experts On CallBEHAVIORAL

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 with Fitbit IonicT1D: One Drop without Fitbit Ionic
One Drop | Experts ReviveBEHAVIORAL

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 with Fitbit Charge 2PD: One Drop without Fitbit Charge 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

One Drop

New York, New York, 10002, United States

Location

Related Publications (14)

  • 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.

    PMID: 26348749BACKGROUND

  • 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.

    PMID: 11333990BACKGROUND

  • 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.

    PMID: 12453955BACKGROUND

  • 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.

    PMID: 28070960BACKGROUND

  • 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.

    PMID: 25440507BACKGROUND

  • 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.

    PMID: 17887992BACKGROUND

  • 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.

    PMID: 16176200BACKGROUND

  • 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.

    PMID: 26071863BACKGROUND

  • 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.

    PMID: 28344183BACKGROUND

  • 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.

    PMID: 28864708BACKGROUND

  • 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.

    PMID: 28794802BACKGROUND

  • 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.

    PMID: 27889809BACKGROUND

  • 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.

    PMID: 25795203BACKGROUND

  • 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.

    PMID: 32540842DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
VP, Health & Behavioral Informatics

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 9, 2018

Study Start

February 23, 2018

Primary Completion

August 31, 2018

Study Completion

December 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)