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

NCT05354297 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2022-07-20

No results posted yet for this study

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 people with diabetes (PWDs) can access online via OneTouch Solutions (Cecelia Health, Fitbit, Noom or Welldoc, each in combination with OneTouch Verio Reflect® blood glucose meter and the OneTouch Reveal® mobile app (or Welldoc app for the Welldoc arm)). ECLIPSE is a large parallel arm digital health study combining advanced blood glucose monitoring solutions with a choice of four different health and wellness applications or services. There are four unique study arms that will run in parallel over one year. The primary (A1c) endpoint for each study arm will be after 6 months and subjects will continue to use the interventions for a full year to generate data on sustained engagement with these products and services, and to collect healthcare utilization and health insurance claims information. Each study arm will differ to some degree in terms of patient baseline demographics (since subjects self-select their own app/intervention) and the experience per arm will be unique, and therefore each study arm will be analysed separately in terms of endpoints and outcomes.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app

Expert guidance via coaching

DEVICE

Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app

Fitness and wellness guidance

DEVICE

Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app

Behavioral weight loss program

DEVICE

Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app

Multi condition support

Sponsors & Collaborators

  • Evidation Health

    collaborator INDUSTRY

  • LifeScan

    lead INDUSTRY

Principal Investigators

  • Wei-Nchih Lee, PhD · Evidation Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2023-04-01
Completion
2023-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05354297 on ClinicalTrials.gov