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Digital Diabetes Management Program for Diabetes

N/A
Waitlist Available
Led By David Kerr, MBChB, DM, FRCPE
Research Sponsored by Omada Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Study Summary

This trial will test if a continuous glucose monitor, when combined with real-time data and guidance from a care team, can help improve diabetes management outcomes.

Who is the study for?
Adults in the U.S. with Type 2 Diabetes, HbA1c ≥8.0%, on a stable glucose-lowering medication regimen for at least 3 months, and willing to adhere to their treatment plan throughout the study. Participants must have a compatible smartphone and be willing to use digital diabetes management apps but cannot be pregnant or planning pregnancy, using certain insulin treatments, or have specific health conditions like severe renal impairment.Check my eligibility
What is being tested?
The trial is testing an integrated solution combining the Abbott FreeStyle Libre CGM sensor with Omada's care team support against standard diabetes care. The impact on blood sugar control (HbA1c) and other diabetes management outcomes will be measured over six months.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the CGM sensor adhesive or discomfort from wearing the device. There could also be privacy concerns related to sharing personal health data through apps.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c
Secondary outcome measures
Change in body weight
Change in daily Time in Range [70-180] mg/dL
Change in diabetes distress
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated SolutionExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Omada Health, Inc.Lead Sponsor
4 Previous Clinical Trials
1,402 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
63 Previous Clinical Trials
24,569 Total Patients Enrolled
Evidation HealthIndustry Sponsor
19 Previous Clinical Trials
267,082 Total Patients Enrolled

Media Library

Online Diabetes Self-Management Education and Support (DSMES) Program Clinical Trial Eligibility Overview. Trial Name: NCT05368454 — N/A
Online Diabetes Self-Management Education and Support (DSMES) Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368454 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05368454 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored in this research endeavor?

"Affirmative, the information on clinicaltrials.gov demonstrates that this experiment is actively recruiting individuals. It was initially announced on May 31st 2022 and updated most recently in the same month. This trial demands 200 participants to be enrolled from a single site."

Answered by AI

Are there any openings currently available for enrollment in this experiment?

"According to clinicaltrials.gov, this medicinal experiment is currently seeking volunteers and has been since it was initially published on May 31st 2022 - the last time any edits were made."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
New York
Virginia
Other
How old are they?
65+
18 - 65
What site did they apply to?
Evidation Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have tried multiple drugs, and this is the trial I am most interested in.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Evaluation of a Digital Diabetes Self-Management Education and Support Program
2022. "Evaluation of a Digital Diabetes Self-Management Education and Support Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368454.
~71 spots leftby Apr 2025
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