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Behavioral Intervention

T1D: One Drop without Fitbit Ionic for Type 2 Diabetes (Fit-One Trial)

N/A
Waitlist Available
Research Sponsored by Chandra Osborn, PhD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months (12 months for sub-study 3)
Awards & highlights

Fit-One 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).

Eligible Conditions
  • Type 2 Diabetes
  • Type 1 Diabetes
  • Prediabetes

Fit-One Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (12 months for sub-study 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (12 months for sub-study 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin A1c
Secondary outcome measures
Diet
Healthcare Utilization
Medication Adherence
+3 more
Other outcome measures
Health-related Productivity
Health-related Quality of Life
Life Satisfaction

Fit-One Trial Design

7Treatment groups
Active Control
Group I: T1D: One Drop without Fitbit IonicActive Control1 Intervention
Group II: PD: One Drop with Fitbit Charge 2Active Control1 Intervention
Group III: T2D: One Drop with Fitbit IonicActive Control1 Intervention
Group IV: PD: One Drop without Fitbit Charge 2Active Control1 Intervention
Group V: T2D: One Drop without Fitbit IonicActive Control1 Intervention
Group VI: T2D: Waitlist ControlActive Control1 Intervention
Group VII: T1D: One Drop with Fitbit IonicActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Chandra Osborn, PhD, MPHLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
New England Journal of MedicineJournal
Prevention of Type 2 Diabetes Mellitus by Changes in Lifestyle Among Subjects with Impaired Glucose Tolerance
Tuomilehto, Jaakko, Jaana Lindström, Johan G. Eriksson, Timo T. Valle, Helena Hämäläinen, Pirjo Ilanne-Parikka, Sirkka Keinänen-Kiukaanniemi, et al.. 2001. “Prevention of Type 2 Diabetes Mellitus by Changes in Lifestyle Among Subjects with Impaired Glucose Tolerance”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm200105033441801.
clinicaltrials.govStudy
Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
Chandra Osborn, PhD, MPH 2018. "Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03459573.
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~70 spots leftby May 2025
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