Mindfulness program tested to tackle diabetes distress
NCT ID NCT05195138
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a mindfulness-based diabetes education program for adults with type 2 diabetes who feel overwhelmed by their condition. Thirty-six participants were randomly assigned to either the mindfulness program or standard diabetes education. The main goal was to see if the program was practical and well-liked, not to prove it works. Researchers collected feedback through focus groups and tracked how many people stayed in the study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mindfulness-Based Diabetes Education
- What this could lead to
- If this approach works, it could offer a way to reduce the emotional burden of managing type 2 diabetes, especially for people with limited resources.
- What could go wrong
- This was a very small pilot study with only 36 participants, so results may not apply to everyone. It looked at feasibility, not whether the program actually improves blood sugar or distress long-term.
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
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36 people
The number who actually took part.
- Started
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May 2023
- Finished
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Dec 2025
- Lead sponsor
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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
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19 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age 19-70 years 2. Diagnosis of type 2 diabetes (based on the presence of two or more outpatient International Classification of Diseases (ICD-10) codes for type 2 diabetes 3. Receipt of care at Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services (one or more visits to primary care or diabetes clinic within the prior year 4. Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale 5. Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%) Exclusion Criteria: 1. Non-English speaking 2. Currently pregnant 3. Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cooper Green Mercy Health Systems
Birmingham, Alabama, 35233, United States
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