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Talking therapy aims to ease the emotional burden of type 1 diabetes

NCT ID NCT05000021

Symptom relief Sponsor: Albert Einstein College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether cognitive behavioral therapy (a type of talking therapy) delivered online, along with a continuous glucose monitor, can reduce diabetes-related distress in adults with type 1 diabetes. About 93 adults aged 18-64 will be randomly assigned to receive either the therapy plus a glucose monitor or just the monitor alone. The goal is to see if adding therapy improves emotional well-being and blood sugar control more than using the monitor by itself.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

96 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Jul 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 to 64 years

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: * Type 1 Diabetes (T1D) duration ≥6 months * English or Spanish speaking * At least moderate Diabetes Distress (DD) (score of ≥2 on T1D-Diabetes Distress Scale) * Stable insulin treatment regimen (insulin prescription, use of pump, etc.) for at least 3 months prior to study enrollment Exclusion Criteria: * Comorbid psychiatric condition, including depression, anxiety, or suicidality, which may be independently associated with the main outcomes of DD or glycemic control. Comorbid psychiatric conditions listed above are being excluded because CBT-DD currently centers on mitigating specifically diabetes distress to improve glycemic outcomes * In treatment for a psychological condition within the last 6 months or on a non-stable dose of psychiatric medication over the last 2 months * Developmental or sensory disability interfering with participation * Current pregnancy, as self-management and glycemic goals differ * Participation in another behavioral intervention study * Use of non-insulin medications or recent medical procedures that would impact glycemic control or use of CGM over the study * Minors * Subjects who do have the capacity to consent

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

  • Yeshiva University

    New York, New York, 10033, United States

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