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

Diabetes Mellitus, Type 2 Clinical Trial

Official title: Evidence for Health Improvement in People With Diabetes Using One Touch & Partner Solutions (ECLIPSE)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 freedom to choose the solution that is right for them, rather than forcibly randomize subjects to a specific study intervention. The intention of this real world study design is to mimic the choice PWDs will have when selecting a diabetes & digital health solution from the OneTouch Solutions website.

A target of 800 people with type 2 diabetes (PwT2Ds) will be recruited and offered one of four interventions with the aim of following 200 PWDs per study arm. Subjects in all four study arms will use a bluetooth connected OneTouch Verio Reflect blood glucose meter (BGM) which features a dynamic color range indicator (DCRI) and blood sugar mentor (BSM) insights. Subjects in three of the four study arms will also sync their Reflect BGM to the OneTouch Reveal (OTR) mobile diabetes app to enable further insights (PWDs in the Welldoc study arm will not use the OTR app).

The 4 unique study arms will also offer PWDs one of the following Partner offerings;

1. Cecelia Health, which offers guidance from certified Diabetes Care and Education Specialists

2. Fitbit, which offers activity and wellbeing insight from use of the Fitbit Inspire 2 tracker, and Fitbit Premium subscription

3. Noom, a psychology-based weight and wellness program

4. Welldoc, which offers personalized health coaching on multiple conditions, namely prediabetes, diabetes, hypertension and heart failure

ECLIPSE will gather glycemic measures, medication adherence, a variety of patient reported outcomes and partner app usage and app engagement analytics over one year. Health economic data (HECON) from PWDs from the year of participation in ECLIPSE will be analysed from a purchased dataset and a comparison will be made to HECON data from the same PWDs for the year prior to taking part in the study. In addition, a matched control group of PwT2D from the same purchased dataset will be compared to the data from all four study arms. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT05354297
• Study type: Interventional
• Source: LifeScan
• Contact: Mike Grady, PhD
• Phone: 07775704444
• Email: mgrady@lifescan.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 26, 2022
• Completion date: September 1, 2023