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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app; Device: Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app; Device: Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app; Device: Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mike Grady, PhD; Phone Number: 07775704444; Email: mgrady@lifescan.com

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94402
      • Evidation Health
      • Contact: Wei-Nchih Lee, MD; Email: wlee@evidation.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cecelia Health; Access to live Cecelia health coach on the telephone for 1 year plus access to Cecelia health coach by text messaging (via the OneTouch Reveal mobile diabetes app). Subjects will be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) diabetes app.	Device: Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app; Expert guidance via coaching
Experimental: Fitbit; Fitbit Inspire 2 wearable plus 1 year subscription to premium Fitbit application. Subjects will also be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) mobile diabetes app.	Device: Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app; Fitness and wellness guidance
Experimental: Noom; Noom behavioural weight loss program subscription for 1 year. Subjects will also be provided with the OneTouch Verio Reflect glucose meter and the OneTouch Reveal (OTR) mobile diabetes app.	Device: Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app; Behavioral weight loss program
Experimental: Welldoc; Multi-condition support program from Welldoc subscription for 1 year. Subjects will also be provided with the OneTouch Verio Reflect glucose meter.	Device: Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app; Multi condition support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in A1c from screening to 3 and 6 months in each of the OneTouch Solutions programs	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in mean blood glucose derived from blood glucose testing throughout the study in each of the OneTouch Solutions programs	3 and 6 months
Change from baseline in diabetes distress as assessed by the diabetes distress scale (DDS) after 3 and 6 months	3 and 6 months
Change from baseline in well-being as assessed by the WHO-5 survey after 3 and 6 months	3 and 6 months
Change from baseline in patient activation measures as assessed by PAM-13 survey after 3 and 6 months	3 and 6 months
Change from baseline in medication adherence as assessed by a medication adherence survey after 3 and 6 months	3 and 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Changes over time in the number of app sessions performed within 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	Over 1 year
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	Over 1 year

Collaborators and Investigators

• Sponsor: LifeScan
• Collaborators: Evidation Health
• Investigators: Principal Investigator: Wei-Nchih Lee, PhD, Evidation Health

Study record dates

Study Major Dates

• Study Start (Anticipated): July 26, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pro00062350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No