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

NCT05354297 | Unknown FDA Device

• 1 other identifier: Pro00062350
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes in A1c from screening to 3 and 6 months in each of the OneTouch Solutions programs

  3 and 6 months

Secondary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (4)

Cecelia Health

EXPERIMENTAL

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

Fitbit

EXPERIMENTAL

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

Noom

EXPERIMENTAL

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

Welldoc

EXPERIMENTAL

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

Interventions

Cecelia Health plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app DEVICE

Expert guidance via coaching

Cecelia Health

Fitbit plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app DEVICE

Fitness and wellness guidance

Fitbit

Noom plus OneTouch Verio Reflect® BGM and OneTouch Reveal® mobile app DEVICE

Behavioral weight loss program

Noom

Welldoc plus OneTouch Verio Reflect® BGM and Welldoc app DEVICE

Multi condition support

Welldoc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• LifeScan: lead
• Evidation Health: collaborator

Study Sites (1)

Evidation Health

San Mateo, California, 94402, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wei-Nchih Lee, PhD

  Evidation Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Grady, PhD

CONTACT

07775704444; mgrady@lifescan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 29, 2022
• Study Start: July 26, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)