Type 1 Diabetes study: ACT1VATE vs DSME/S
Official title ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04933851
What this study is testing
- What it's testing
- This study is testing whether ACT1VATE helps people with type 1 diabetes lower their blood sugar and feel less emotional distress. It compares the program to usual diabetes education and support.
- Who it's for
- You may be able to join if you are an adult with type 1 diabetes, your blood sugar is not well controlled, and you feel significant emotional distress related to your diabetes.
- What's involved
- You will receive the ACT1VATE program, which includes counseling and support to manage emotions. You will also have regular check‑ins and may do some simple tests to track your blood sugar and mood.
- Time commitment
- The study lasts several months, with multiple visits to the clinic or home for counseling, blood sugar checks, and questionnaires.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
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
- Spanish or English-speaking
- Type 1 diabetes
- Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days
- Screen positive for diabetes distress
You likely can't join if
- Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider
- Plans to move out of the San Diego area in the next 12 months
- Lack of technology capability required to complete online surveys and telemedicine visit
The study team makes the final eligibility decision.
Where it is enrolling
- 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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 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.