Online Diabetes Self-Management Education and Support (DSMES) Program for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Evidation Health, San Mateo, CA
Type 2 Diabetes Mellitus+2 More
Online Diabetes Self-Management Education and Support (DSMES) Program - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Type 2 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Type 2 Diabetes Mellitus

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 3 months, 6 months

Month 6
Change in HbA1c
Change in body weight
Change in daily Time in Range [70-180] mg/dL
Change in diabetes distress
Change in resting blood pressure

Trial Safety

Safety Progress

1 of 3

Other trials for Type 2 Diabetes Mellitus

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Integrated Solution
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Online Diabetes Self-Management Education and Support (DSMES) Program · No Placebo Group · N/A

Integrated Solution
Behavioral
Experimental Group · 1 Intervention: Online Diabetes Self-Management Education and Support (DSMES) Program · Intervention Types: Behavioral
Standard of Care
Behavioral
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months
Closest Location: Evidation Health · San Mateo, CA
Photo of california 1Photo of california 2Photo of california 3
2017First Recorded Clinical Trial
2 TrialsResearching Type 2 Diabetes Mellitus
12 CompletedClinical Trials

Who is running the clinical trial?

Abbott Diabetes CareIndustry Sponsor
56 Previous Clinical Trials
23,719 Total Patients Enrolled
9 Trials studying Type 2 Diabetes Mellitus
1,220 Patients Enrolled for Type 2 Diabetes Mellitus
Omada Health, Inc.Lead Sponsor
4 Previous Clinical Trials
1,402 Total Patients Enrolled
1 Trials studying Type 2 Diabetes Mellitus
27 Patients Enrolled for Type 2 Diabetes Mellitus
Evidation HealthIndustry Sponsor
17 Previous Clinical Trials
242,375 Total Patients Enrolled
1 Trials studying Type 2 Diabetes Mellitus
297 Patients Enrolled for Type 2 Diabetes Mellitus
Sarah Linke, PhDStudy DirectorOmada Health, Inc.
David Kerr, MDPrincipal InvestigatorEvidation Health
6 Previous Clinical Trials
1,384 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years old.
You have a diagnosis of type 2 diabetes.
You must be able to speak, read, and understand English as the primary language.
You are willing and able to provide written, signed, and dated informed consent.
You have a self-reported HbA1c value ≥8.
You have a HbA1c level greater than or equal to 8.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.