Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Evidation Health, San Mateo, CA
Diabetes Mellitus, Type 2+1 More
Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Over 1 year

3 and 6 months
Change from baseline in diabetes distress as assessed by the diabetes distress scale (DDS) after 3 and 6 months
Change from baseline in medication adherence as assessed by a medication adherence survey after 3 and 6 months
Change from baseline in patient activation measures as assessed by PAM-13 survey after 3 and 6 months
Change from baseline in well-being as assessed by the WHO-5 survey after 3 and 6 months
Change in mean blood glucose derived from blood glucose testing throughout the study in each of the OneTouch Solutions programs
Changes in A1c from screening to 3 and 6 months in each of the OneTouch Solutions programs
Over 1 year
Change from baseline in A1c as a function of the number of app sessions performed within each of the OneTouch Solutions programs
Changes over time in the number of app sessions performed within each of the OneTouch Solutions programs
Quantify the number of medical insurance claims made by subjects within each of the OneTouch Solutions programs using data harvested from a large medical insurance dataset

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Trial Design

4 Treatment Groups

Welldoc
1 of 4
Cecelia Health
1 of 4
Fitbit
1 of 4
Noom
1 of 4
Experimental Treatment

800 Total Participants · 4 Treatment Groups

Primary Treatment: Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app · No Placebo Group · N/A

Welldoc
Device
Experimental Group · 1 Intervention: Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app · Intervention Types: Device
Cecelia Health
Device
Experimental Group · 1 Intervention: Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app · Intervention Types: Device
Fitbit
Device
Experimental Group · 1 Intervention: Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app · Intervention Types: Device
Noom
Device
Experimental Group · 1 Intervention: Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 1 year
Closest Location: Evidation Health · San Mateo, CA
2017First Recorded Clinical Trial
5 TrialsResearching Diabetes Mellitus, Type 2
12 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of type 2 diabetes.
You have a blood glucose level of 7.5% or less but greater than 12% at screening.
You have a compatible smartphone and are willing to redownload apps if they change phones during the study.
You are currently taking oral or injected anti-diabetic medication (for lowering your blood glucose) with or without insulin therapy (insulin injections or an insulin pump) at screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.