Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions
Status unconfirmed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT05354297
- Run by
- LifeScan
- People needed
- 800
- Starts
- 2022-07-26
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2022-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Evidation Health — San Mateo, California, United States
Full record on ClinicalTrials.gov
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