Diabetes Type 2 study: Project Dulce Telehealth vs Project Dulce Live
Official title Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
ClinicalTrials.gov ID: NCT05416060
What this study is testing
- What it's testing
- This study is testing whether digital tools can improve diabetes self‑management for people who have low income or low health literacy. It compares in‑person classes, online classes, and text messages.
- Who it's for
- You may be able to join if you have type 2 diabetes, live in a low‑income area, and can use a phone or text messages.
- What's involved
- You will attend a class in person or online, or receive text messages that give tips on healthy habits. You will also fill out simple surveys and share your health data with the study team.
- Time commitment
- The study lasts about 6 months and includes a few visits or calls to check in on your progress.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 people 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
See the full eligibility criteria
- 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
- 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 people 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
The study team makes the final eligibility decision.
Where it is enrolling
- Chula Vista, California, United States
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chula Vista, California, United States; San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.