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Evaluation of a Digital Diabetes Self-Management Education and Support Program

NCT05368454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-10

No results posted yet for this study

Summary

The goal of this study is to examine the efficacy of an integrated solution, defined as a combination of the Abbott FreeStyle Libre 14-day CGM sensor and the Omada care team's receipt of real-time, continuous glucose data from the sensor and incorporation of this data into their care delivery within the context of the Omada for Diabetes program for adults with Type 2 Diabetes (T2D). This randomized control trial will test the impact of the integrated solution on HbA1c, CGM-derived metrics and other relevant diabetes management outcomes over six months compared to the current standard of care.

Conditions

Interventions

BEHAVIORAL

Online Diabetes Self-Management Education and Support (DSMES) Program

An online program for Diabetes Self-Management, Education and Support (DSMES) that includes personal coaching by a certified Diabetes Care and Education Specialist (CDCES), tracking tools, and FreeStyle Libre CGMs, a wearable sensor with data scanning ability accessed through the smartphone app.

BEHAVIORAL

Standard of Care

All participants randomized to the standard of care/control arm will be asked to continue with their current care plan and care team for management of their diabetes.

Sponsors & Collaborators

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • Evidation Health

    collaborator INDUSTRY

  • Omada Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Linke, PhD · Omada Health, Inc.

  • David Kerr, MBChB, DM, FRCPE · Evidation Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2024-01-24
Completion
2024-01-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05368454 on ClinicalTrials.gov