Status:

UNKNOWN

Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions

Lead Sponsor:

LifeScan

Collaborating Sponsors:

Evidation Health

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

ECLIPSE will evaluate the clinical and economic value of OneTouch Solutions in a real world study design. OneTouch Solutions describes a selection of devices and health and wellness solutions that peo...

Detailed Description

ECLIPSE (Evidence for health improvement in people with diabetes using One Touch \& Partner Solutions) is a large parallel arm digital health study that will allow people with diabetes (PWDs) the free...

Eligibility Criteria

Inclusion

  • Self reports a diagnosis of type 2 diabetes
  • HbA1c ≥7.5% but ≤12% at screening
  • Currently instructed by a health care provider (HCP) to use a blood glucose meter to test blood sugar
  • Has a compatible smartphone and willing to redownload apps if they change phones during the study
  • Has a stable and consistent home and/or office internet connection
  • Currently on at least 1 oral (by mouth) or injected anti-diabetic medication (for lowering your blood glucose) with or without insulin therapy (insulin injections or an insulin pump) at screening

Exclusion

  • Currently pregnant or planning to be pregnant in the next 12 months
  • Body Mass Index \< 27
  • Currently using a CGM (Continuous glucose monitor) or have used a personal CGM in the past 3 months
  • Currently using a OneTouch Verio Reflect meter
  • For FitBit arm only: Currently uses related fitness applications (e.g., MyFitnessPal, JEFIT, Fitness Coach, Yoga-Go, etc.) or wearable device (e.g., Fitbit, Apple Watch, Garmin, Withings, etc.) in the past 6 months

Key Trial Info

Start Date :

July 26 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2023

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT05354297

Start Date

July 26 2022

End Date

September 1 2023

Last Update

July 20 2022

Active Locations (1)

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1

Evidation Health

San Mateo, California, United States, 94402