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New therapy aims to tackle emotional toll of type 1 diabetes

NCT ID NCT04933851

Symptom relief Sponsor: Scripps Whittier Diabetes Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a psychological therapy program called ACT1VATE to standard diabetes education in 250 adults with type 1 diabetes who have high emotional distress and poor blood sugar control. The therapy is delivered in five group sessions via video call. Researchers will measure changes in blood sugar levels and diabetes-related distress over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acceptance and Commitment Therapy (ACT)-based group telemedicine sessions
What this could lead to
If successful, this could provide an effective way to reduce diabetes-related emotional distress and improve blood sugar control in adults with type 1 diabetes.
What could go wrong
This is a Phase 2 trial with 250 participants, so results are still preliminary. The intervention is behavioral, so benefits may vary widely between individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Spanish or English-speaking * Type 1 diabetes * Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days * Screen positive for diabetes distress Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Scripps Whittier Diabetes Institute

    RECRUITING

    San Diego, California, 92121, United States

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