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Digital Diabetes Self-Management for Diabetes (Dulce Digital Trial)

N/A
Recruiting
Led By Athena Philis-Tsimikas, MD
Research Sponsored by Scripps Whittier Diabetes Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Type 2 Diabetes
Diagnosis of Type 2 Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Dulce Digital Trial Summary

This trial will compare the effectiveness of two digital approaches to improving self-management and digital health skills of underserved participants with diabetes, compared to traditional in-person self-management education.

Who is the study for?
This trial is for Hispanic/Latino adults with Type 2 Diabetes, registered at Scripps Health, and an HbA1c level ≥8% in the last 60 days. It's not for those with recent substance abuse issues, severe health problems like anemia or liver dysfunction, minimal literacy, or who don't speak Spanish/English.Check my eligibility
What is being tested?
Dulce Digital 2.0 evaluates two digital adaptations of Project Dulce aimed at improving diabetes self-management via text messages and telehealth platforms compared to traditional in-person education.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medications, typical drug side effects are not expected. However, participants may experience discomfort from increased engagement with technology.

Dulce Digital Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Type 2 Diabetes.
Select...
I have been diagnosed with Type 2 Diabetes.

Dulce Digital Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Secondary outcome measures
Change from Baseline Diabetes Distress (DDS-17) at 3 months
Change from Baseline Diabetes Distress (DDS-17) at 6 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months
+1 more

Dulce Digital Trial Design

3Treatment groups
Experimental Treatment
Group I: Project Dulce Telehealth DSME/SExperimental Treatment1 Intervention
Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.
Group II: Project Dulce Live DSME/SExperimental Treatment1 Intervention
Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.
Group III: Dulce DigitalExperimental Treatment1 Intervention
Patients will participate in a text-based diabetes self-management educational and support (DSME/S) program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.

Find a Location

Who is running the clinical trial?

Scripps Whittier Diabetes InstituteLead Sponsor
17 Previous Clinical Trials
5,239 Total Patients Enrolled
3 Trials studying Diabetes
1,422 Patients Enrolled for Diabetes
Athena Philis-Tsimikas, MDPrincipal InvestigatorScripps Health
13 Previous Clinical Trials
4,509 Total Patients Enrolled
3 Trials studying Diabetes
1,422 Patients Enrolled for Diabetes

Media Library

Dulce Digital Text-Based Education Clinical Trial Eligibility Overview. Trial Name: NCT05416060 — N/A
Diabetes Research Study Groups: Dulce Digital, Project Dulce Telehealth DSME/S, Project Dulce Live DSME/S
Diabetes Clinical Trial 2023: Dulce Digital Text-Based Education Highlights & Side Effects. Trial Name: NCT05416060 — N/A
Dulce Digital Text-Based Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416060 — N/A

Frequently Asked Questions

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

Is it currently feasible for individuals to enroll in this experiment?

"The clinicaltrials.gov portal reveals that this trial is no longer enrolling patients, despite the fact it was initially posted on November 1st 2022 and last edited nine days later. But there are 1392 other medical studies actively recruiting at present."

Answered by AI

What is the intended goal of this medical research?

"This trial will be evaluated over a 3-month period, its primary outcome being the Change from Baseline in Glycosylated Hemoglobin A1C (HbA1c) at 6 months. Alongside that, secondary endpoints include the Diabetes Distress Scale (DDS-17), which assesses overall emotional distress related to diabetes on a 1-6 scale; as well as assessing Treatment Satisfaction with 8 questions ranging from 0 ("very dissatisfied", "very inconvenient") to 6 ("very satisfied", "very convenient"). This is further divided into two factors: one gauging satisfaction and willingness to continue treatment (total score"

Answered by AI

Who else is applying?

What state do they live in?
Alabama
California
How old are they?
65+
18 - 65
What site did they apply to?
Scripps Whittier Diabetes Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~44 spots leftby Sep 2024