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Mindfulness may lower blood sugar in stressed diabetes patients

NCT ID NCT04016415

Symptom relief Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether an online mindfulness program could help adults with type 1 or type 2 diabetes lower their blood sugar. Over 300 participants with high stress and poor glucose control were randomly assigned to either an 8-week Mindfulness-Based Stress Reduction course or a stress management education class. Researchers measured changes in hemoglobin A1c at 2 and 6 months to see if reducing stress improved diabetes control.

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 Stress Reduction (MBSR) program
What this could lead to
If it works, this could offer a practical, non-drug way to help people with diabetes manage stress and potentially improve blood sugar levels.
What could go wrong
This is a completed trial, but the intervention is behavioral and effects may be modest. Results depend on participants' engagement and may not apply to everyone with diabetes.

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

309 people

The number who actually took part.

Started

Jul 2020

Finished

Aug 2024

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: 1. Men and Women 2. Age 18 years or older 3. Diagnosed with diabetes for at least one year 4. Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session) 5. High Subjective stress defined as Perceived Stress Scale-10 score ≥ 12 6. Available for the intervention sessions with reasonable certainty 7. Have a device equipped with internet connection, camera and microphone and willingness to interact with study staff and class instructors virtually/remotely via this platform 8. Must have a Primary Care Provider (PCP) 9. Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence Exclusion Criteria: 1. Current suicidality 2. History of, or meets Mini International Neuropsychiatric Interview (MINI) structured interview criteria for, bipolar disorder, psychosis, or other significant psychopathology; Those with depression or anxiety will be allowed to participate since they are under the care of a PCP. 3. Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 weeks 4. Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months) 5. Inability to read, write or speak English 6. Current enrollment in a stress reduction program, or in any other investigative study 7. Previous participation in a mindfulness-based stress reduction (MBSR) course 8. Pregnant women 9. Have a household member who is currently, or was previously, assigned to study treatment

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Conditions

The condition(s) this trial relates to.

Stress, Psychological type 1 diabetes mellitus type 1 diabetes mellitus 1 type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2 Diabetes mellitus, type 1 Stress

Contacts and locations

Locations

  • Penn State College of Medicine, Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

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