Dulce Digital 2.0: Improving Diabetes Self-Management with Digital Tools

This study, called "Dulce Digital 2.0," is looking at new ways to help people with Type 2 Diabetes manage their health using digital tools. It's testing three different approaches: a text-based education program (Dulce Digital Text-Based Education), a group telehealth program (Project Dulce Telehealth), and a live group education program (Project Dulce Live). These programs offer support, education, and tips for managing diabetes. The study is for Hispanic/Latino adults who are Scripps Health patients, have Type 2 Diabetes, and a recent A1C (a measure of blood sugar over time) of 8% or higher. Researchers will measure changes in A1C at 3 and 6 months to see how well these programs work.

Study design
This interventional study plans to enroll 150 participants to test different behavioral interventions for diabetes self-management.
What's involved
Participants will receive ongoing support via text messages for 6 months, or participate in a 5-week group-based diabetes self-management education program delivered either via telehealth or in person.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in their A1C at 3 months and 6 months.

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NCT05416060

Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age

Recruiting
NAAges 18+InterventionalPrevention
Scripps Whittier Diabetes Institute
~150 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Dulce Digital Text-Based EducationProject Dulce TelehealthProject Dulce Live

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Measured over 3 months
+1 more outcome measured
Diabetes Type 2
2 sites across 1 states
California2
  • Athena Philis-Tsimikas, MD · PRINCIPAL_INVESTIGATOR · Scripps Health

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Eligibility criteria

Inclusion

Hispanic/Latino adults who are registered patients of Scripps Health
Diagnosis of Type 2 Diabetes
HbA1c greater than or equal to 8% within the last 60 days

Exclusion

Severe illness precluding visits to clinic
Liver function tests (ALT and AST) \> 3 times the upper limit of normal
Body mass index ≤ 23 kg/cm
History of malignancy, except subjects who have been disease-free for \>2 years, or whose only malignancy has been basal or squamous cell skin carcinoma
Creatinine \>3.5
History of drug or alcohol abuse within 12 months prior to randomization
Current enrollee in DSME/S
Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
Anemia
Lack of minimal literacy needed to participate in the text intervention
Severe auditory or visual problems
Primary language other than Spanish or English
Not willing to carry a mobile phone
Pregnant
Plans to relocate
  • Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months3 months

    Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.

  • Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months6 months

    Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.