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NCT05416060 · ClinicalTrials.gov registry record · NA

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

A NA study of Diabetes Type 2, sponsored by Scripps Whittier Diabetes Institute.

Recruiting
Registry status
NA
Development phase
150
Enrollment target
2
Study locations

NCT05416060: Recruiting NA study of Diabetes Type 2, sponsored by Scripps Whittier Diabetes Institute.

NCT05416060 is a NA study of Diabetes Type 2 that is actively recruiting participants, run by Scripps Whittier Diabetes Institute. The registered enrollment target is 150 participants, below the 661-participant average among 24 other Diabetes Type 2 trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05416060, a NA study of Diabetes Type 2, is actively recruiting participants, sponsored by Scripps Whittier Diabetes Institute.

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
2
Study locations

Study Summary

The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.

Primary Outcome

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.

Conditions Studied

Interventions

  • BEHAVIORAL Dulce Digital Text-Based Education
  • BEHAVIORAL Project Dulce Telehealth
  • BEHAVIORAL Project Dulce Live

Study Locations (2)

California

  • Scripps Chula Vista Diabetes Center - Chula Vista
  • Scripps Whittier Diabetes Institute - San Diego

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2023-03-23
Est. Completion 2026-01-31
Phase NA

What NCT05416060 shows while recruiting

NCT05416060 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 661-participant average among 24 other Diabetes Type 2 trials with a reported enrollment target (77% lower).

The record links to 1 condition, with Diabetes Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Dulce Digital Text-Based Education is the first listed.

NCT05416060 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05416060 about?

NCT05416060 is a clinical study titled "Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age". The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral o...

What is the current status of trial NCT05416060?

This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2023-03-23. Estimated completion is 2026-01-31.

What conditions does trial NCT05416060 study?

This clinical trial studies the following conditions: Diabetes Type 2.

What interventions are being tested in trial NCT05416060?

The interventions under investigation include: Dulce Digital Text-Based Education (BEHAVIORAL), Project Dulce Telehealth (BEHAVIORAL), Project Dulce Live (BEHAVIORAL).

Who is sponsoring clinical trial NCT05416060?

This trial is sponsored by Scripps Whittier Diabetes Institute, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05416060 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05416060's enrollment target sits among peer trials

150 13th of 24 higher than 12 of 24 other Diabetes Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05416060, the US trial registry maintained by the National Library of Medicine. NCT05416060 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.