Mindfulness Based Stress Reduction for Diabetes, Autoimmune

Phase-Based Estimates
1
Effectiveness
1
Safety
Penn State College of Medicine, Penn State Milton S Hershey Medical Center, Hershey, PA
Diabetes, Autoimmune+3 More
Mindfulness Based Stress Reduction - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Diabetes, Autoimmune

Study Summary

This study is evaluating whether an online mindfulness program may help improve glucose control in adults with uncontrolled type 1 or type 2 diabetes.

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Eligible Conditions

  • Diabetes, Autoimmune
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Stress (Psychology)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Mindfulness Based Stress Reduction will improve 1 primary outcome and 5 secondary outcomes in patients with Diabetes, Autoimmune. Measurement will happen over the course of baseline and 2 months.

baseline and 2 months
Change in Diabetes Distress Scale from Baseline to 2 months
Change in Hemoglobin A1c from Baseline to 2 months
Change in Perceived Stress Scale-10 from Baseline to 2 months
baseline and 6 months
Change in Diabetes Distress Scale from Baseline to 6 months
Change in Hemoglobin A1c from Baseline to 6 months
Change in Perceived Stress Scale-10 from Baseline to 6 months

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Mindfulness Based Stress Reduction
muscle soreness
2%
sleep disruption
0%
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01033851) in the Mindfulness Based Stress Reduction ARM group. Side effects include: muscle soreness with 2%, sleep disruption with 0%.

Trial Design

2 Treatment Groups

Stress Management Education
Mindfulness Based Stress Reduction

This trial requires 290 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mindfulness Based Stress Reduction is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mindfulness Based Stress Reduction
Behavioral
Stress Management Education
Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Stress Reduction
2012
Completed Phase 4
~3160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and 6 months for reporting.

Who is running the study

Principal Investigator
N. R.
Prof. Nazia Raja-Khan, Associate Professor of Medicine, Obstetrics and Gynecology, and Psychiatry and Behavioral Health
Milton S. Hershey Medical Center

Closest Location

Penn State College of Medicine, Penn State Milton S Hershey Medical Center - Hershey, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Men and Women
Diagnosed with diabetes for at least one year
Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session)
Available for the intervention sessions with reasonable certainty
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
You must have a primary care provider. show original
You must be between the ages of 18 and 65 years. show original
You have a high subjective stress level. show original
You must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can diabetes, autoimmune be cured?

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Diabetes can be cured. The key lies in not forcing the body to make autoimmune responses, but letting the body make these when needed, and in limiting the amount of oxidative damage from the body's immune system as much as possible.

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How many people get diabetes, autoimmune a year in the United States?

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Approximately 9 million Americans are living in the United States with diabetes. Among adults with diabetes, more than 16 million have autoimmune disease. The number of adults living with diabetes and autoimmune disease is expected to rise to 21 million a year by 2022.

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What are common treatments for diabetes, autoimmune?

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This article highlights several ways both inpatient and outpatient care can be provided to patients with chronic disorders such as chronic infection, type 1 diabetes, and type 2 diabetes. A multidisciplinary approach is encouraged to address the complex problems these patients face. Copyright © 2016 John Wiley & Sons, Ltd.

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What causes diabetes, autoimmune?

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In contrast to the common assumption, diabetes, autoimmunity, and aging are not the sole risk factors for development of diabetes. On the contrary, they are part of a complex mixture of genetic, psychological, environmental and metabolic factors of which the individual variability of their severity and speed of development is the ultimate determinant.

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What is diabetes, autoimmune?

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Diabetes is a serious condition that is due to excessive use of glucose in the body. It is a chronic disease that is highly disabling and that affects people aged 20 to 75 years in a way that is similar to arthritis. It should be considered while evaluating the cause of arthritis.

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What are the signs of diabetes, autoimmune?

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Signs of diabetes, such as excessive thirst, frequent urination, foot swelling and other diabetic foot complications are uncommon in women. However, women with diabetes may present with a range of clinical presentations. These women may present with pain in the legs, skin, joints or foot that is unrelated to the diabetes.

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What are the common side effects of mindfulness based stress reduction?

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The majority of adverse side effects reported in MBM studies are not uncommon in any of the domains studied and include symptoms of physical discomfort, pain, fatigue, and insomnia. Results from a recent clinical trial underscore the importance of a critical appraisal of the quality of the study methodology and outcome assessments and should not be used to undermine self-help approaches to health promotion.

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Does mindfulness based stress reduction improve quality of life for those with diabetes, autoimmune?

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MBSR intervention appears to be an acceptable and feasible intervention for improving QoL among persons with diabetes and associated autoimmune conditions. Further research is needed to determine if improvements in QoL persist over 12 months.

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Have there been any new discoveries for treating diabetes, autoimmune?

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There have been many new discoveries in the area of diabetes treatment in the last few years due to the growing number of studies and journals. The most commonly used type of diabetes treatments are oral or injectable medications. However, there is still a great need for new and innovative treatments to treat diabetes. Currently the most researched types of diabetic medications are GLP-1 agonists. This is because the Glucagon-like peptide-1 (GLP-1) is an important molecule in controlling blood glucose levels because it inhibits the hormone insulin. This leads to an increase in glucagon levels. These types of treatments are effective at reducing the level of blood sugar in diabetic patients.

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Does diabetes, autoimmune run in families?

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The association of diabetes with autoimmune disease, either in the presence or absence of diabetes, was very similar to the association of the autoimmune condition with diabetes itself. Identifying family members with diabetes or autoimmune disease will usually lead to the discovery of a new gene or gene locus.

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What is the latest research for diabetes, autoimmune?

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[Researchers are doing good work for understanding and treating diabetes, autoimmune disease in the future: there has been a lot of new research happening on these topics (published in [PLoS ONE]]) and it will be interesting to see what is going to happen next in diabetes and autoimmunity research. For any patient that has had [diabetes or autoimmune disease] go to {withpower.com/bio/health/diabetes-or-autoimmune-disease-clinical-trials-pdq), and ask your practitioner for clinical trials that you might be suitable for. (http://www.powerbio.

Unverified Answer

What is the average age someone gets diabetes, autoimmune?

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The mean [age of diagnosis] for diabetes is 57.3 years (SD = 9.8; range = 28.1-84.1), and for autoimmune diabetes is 48.2 years (SD = 11.5; range: 22.6-70.6). In this sample, approximately 70% are diagnosed before age 55 years, and 18% before age 60 years. Findings from a recent study are comparable with existing data that show the mean [age of diagnosis] for diabetes is 44.9 years (SD = 16.6; range: 21.4-79.3), and for autoimmune diabetes is 39.2 years (SD = 13.0; range: 11.8-70.

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