Treatment for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Scripps Whittier Diabetes Institute, San Diego, CA
Diabetes Mellitus, Type 2+2 More
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study aims to culturally adapt an existing American Diabetes Association (ADA)-recognized diabetes self-management and support or DSMES (Diabetes Self Management Education Support) program (Project Dulce) and integrate an evidence-based text messaging program (Dulce Digital) for implementation in Filipino Americans (FAs) with type 2 diabetes mellitus (T2DM). Cultural adaptations aims to facilitate and enhance patient centered approaches and increase participant engagement by addressing barriers to DSMES unique to FAs, such as linguistic challenges, health literacy and numeracy, cultural beliefs and values, and technology access and use. In addition, this study aims to examine the effectiveness of the culturally and digitally adapted Project Dulce + Dulce Digital in improving diabetes knowledge, belief, attitudes, hemoglobin A1C (glycosylated hemoglobin), and self-management behaviors at baseline to 3 months and 6 months. The unprecedented increase of T2DM prevalence among racial and ethnic minority populations including FAs in recent decades demands for effective strategies to meet the needs in DSMES in this population. The outcomes of the current study will demonstrate that the culturally adapted Project Dulce and integration of Dulce Digital is effective in addressing the needs FAs, an underserved racial and ethnic minority group in high need of culturally appropriate DSMES.

Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

6 Primary · 8 Secondary · Reporting Duration: 6 months

3 months
Change from Baseline Diabetes Knowledge at 3 months
Change from Baseline Health Belief Model Scale at 3 months
Change in Baseline Block Food Frequency Questionnaire at 3 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units
Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
6 months
Change from Baseline Diabetes Knowledge at 6 months
Change from Baseline Health Belief Model Scale at 6 months
Change in Baseline Block Food Frequency Questionnaire at 6 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units
Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
Change in Baseline Self-Efficacy for Diabetes Scale at 6 months
Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
Participant Satisfaction
Recruitment and Retention

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Trial Design

0 Treatment Group

48 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Scripps Whittier Diabetes Institute · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
2010First Recorded Clinical Trial
15 TrialsResearching Diabetes Mellitus, Type 2
18 CompletedClinical Trials

Who is running the clinical trial?

Scripps Whittier Diabetes InstituteLead Sponsor
15 Previous Clinical Trials
5,679 Total Patients Enrolled
9 Trials studying Diabetes Mellitus, Type 2
3,141 Patients Enrolled for Diabetes Mellitus, Type 2
Emily Rose N. San Diego, PhDPrincipal InvestigatorScripps Whittier Diabetes Institute

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are Filipino.
You are registered in the community clinic.
HbA1c ≥8% within 1 month of screening.

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.