See if you are eligible to participate in this study looking at whether the One Touch Solutions platform and its associated partner programs can help people better manage their diabetes and save money.
Clinical Trials Identifier: NCT05354297
Trial name: Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions (ECLIPSE)
Principal Investigator: Dr. Jennifer Lee, lead research scientist at Evidation Health.
Diabetes type: Type 2 diabetes
Trial Sponsor: LifeScan
Why does this trial matter?
The majority of people with type 2 diabetes rely on a blood glucose meter (BGM) to help them track their glucose levels and manage their diabetes on a daily basis. New tools such as coaching apps and wellness programs can work alongside a person’s BGM to help them better understand how certain behaviors affect their glucose levels.
Lifescan, the maker of popular BGM devices such as the OneTouch Verio Reflect and One Touch Verio Flex meters, as well as the OneTouch Reveal mobile app, recently launched a new platform called One Touch Solutions. This platform allows you to connect your OneTouch BGM with a variety of top-rated health services (such as Noom, Cecilia Health, Fitbit, and Welldoc) including integrating and sharing your health data.
Researchers hope to collect real-world data on how each of these health and wellness solutions (Noom, Cecilia Health, Fitbit, and Welldoc), when combined with the OneTouch BGM and app, may be able to help you lower your glucose levels and even save you money. Real world data is helpful because it can show that a device or technology is effective even in a real-world setting (and not just in a tightly controlled and monitored clinical trial).
What is this trial measuring?
The study will enroll approximately 800 people with type 2 diabetes and will run for one year. Participants will be able to self-select which intervention group they wish to be a part of, with a goal of having roughly 200 participants in each of the following groups:
Cecelia Health plus OneTouch Verio Reflect BGM and OneTouch Reveal mobile app – Cecelia Health provides a one-on-one virtual support program for diabetes management delivered by a certified diabetes care and education specialist (CDCES).
Fitbit plus OneTouch Verio Reflect BGM and OneTouch Reveal mobile app – Participants will receive the wearable Fitbit Inspire 2 tracker and Fitbit Premium service which allows you to track daily activity, nutrition, and sleep to see how these factors influence your glucose levels.
Noom plus OneTouch Verio Reflect BGM and OneTouch Reveal mobile app – Noom is a weight management program focused on behavior change. It uses psychology-based education, tools, and coaching to help you build healthier habits, lose weight, and track your glucose management.
Welldoc plus OneTouch Verio Reflect BGM and Welldoc app – Welldoc is a personalized, artificial intelligence-driven digital health coaching app for people with diabetes, hypertension, heart failure, and/or prediabetes. It provides real-time automated coaching messages based on your glucose readings.
Participants will use the BGM with their chosen health and wellness solution for one year to help them manage their diabetes, just as they would if they had purchased One Touch Solutions outside of this trial. During this time, researchers will be collecting health data, patient-reported outcomes, and economic data. Researchers are primarily measuring participants’ change in A1C, taken at baseline and three and six months into the trial. In addition they will be measuring changes in mean blood glucose, diabetes distress, well-being, medication use, app use, and medical insurance claims.
Researchers hope to see, in a real-world context where people are allowed to self-select which platforms they want to use, whether or not these solutions can help people lower their glucose levels, improve wellbeing, and save money.
Trial length: One year.
Trial location: The trial is coordinated by Evidation Studies, who will be recruiting for the study remotely.
Are you interested?
You may be eligible to join the study if you:
Have type 2 diabetes.
Have an A1C between 7.5% and 12%.
Have a BMI greater than 27.
Have a compatible smartphone.
Are currently on at least one oral or injected diabetes medication with or without insulin therapy.
Are not pregnant.
Are not currently using a continuous glucose monitor (CGM), nor have you used a personal CGM in the past three months.
You can see a full list of eligibility and exclusion criteria here.
For more information: Contact Dr. Mike Grady at email@example.com or learn more about Evidation Health here.