TunedIn for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Diabetes Mellitus+2 More
TunedIn - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a program can help reduce diabetes distress.

See full description

Eligible Conditions

  • Diabetes Mellitus
  • Diabetes Distress
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether TunedIn will improve 2 primary outcomes and 9 secondary outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of Change from baseline to 12 months.

Month 12
Broad quality of life
Depression
Diabetes Distress
Hemoglobin A1c (HbA1c)
Hypoglycemic episodes
Insulin adherence
Interpersonal emotion regulation
Non-judging of experience
Nonreactivity to inner experience
Personal Control Over Illness
Self-compassion - Diabetes (SCS-D)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

StreamLine
1 of 3
FixIt
1 of 3
TunedIn
1 of 3
Experimental Treatment

This trial requires 426 total participants across 3 different treatment groups

This trial involves 3 different treatments. TunedIn is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

StreamLine
Behavioral
Diabetes education, behavioral management
FixIt
Behavioral
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
TunedIn
Behavioral
Diabetes distress reduction, emotion regulation techniques.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to 12 months for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase] antibody testing) on intensive insulin treatment;
Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40;
Have a recent HbA1c of 7.5% or higher;
Not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous glucose monitor) in the past 6 months;
Ability to speak/read English.
Internet access through a computer or smart phone;

Patient Q&A Section

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

"About 27 million US residents had diabetes in 2002. Results from a recent clinical trial demonstrates that approximately 17.5 million Americans new diagnosed and 14.6 million persons are diagnosed with type 2 diabetes. The high prevalence of diabetes is attributable primarily to an increase in the prevalence of type II diabetes." - Anonymous Online Contributor

Unverified Answer

What causes diabetes mellitus?

"Recent findings does not support a single cause for diabetes mellitus, but suggests that there are multiple factors of which genetics plays a significant role." - Anonymous Online Contributor

Unverified Answer

What is diabetes mellitus?

"Diabetes has been shown to be more common in the general U.K. population. It causes serious complications such as heart disease and strokes, and poses an increased risk of death.\n" - Anonymous Online Contributor

Unverified Answer

Can diabetes mellitus be cured?

"Diabetes mellitus can be cured. A reduction in risk factors, such as healthy eating patterns and exercise, can lead to remission. Once remission has begun, insulin injection is an effective treatment. Further work is needed to verify these results by randomized control trials." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes mellitus?

"More than 90% of people with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) were found to require oral antihyperglycaemic medication to control their blood glucose levels, which suggests that the disease is poorly controlled. For nearly half of type 1 diabetics a dietary therapy (restricted diets) or pharmacological therapy (insulin injections or oral agents) was sufficient to control their blood glucose levels. Only about 11% found a significant improvement with medication while the rest had to change medication. We hypothesise that some patients feel better when using drug treatment due to the improved adherence to diabetes therapy. A systematic review revealed that adherence to medication has a positive effect on health outcomes in patients with diabetes. As a way of improving adherence to medication the medical team needs to be more helpful." - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes mellitus?

"There are many known symptoms of diabetes mellitus, including excessive urination, frequent nighttime urination, frequent dizziness, blurry vision, shortness of breath, and itching. However, only about 25% of patients are bothered by diabetes-related sleep problems. Symptoms are often poorly controlled with drugs. There are many other chronic diseases, but if any of these is present, they are usually of lesser concern and should not be the focus of diagnostic evaluation." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tunedin for therapeutic use?

"The combination of two treatments leads to significant improvements in diabetes control compared with monotherapy. Tuning in is a novel approach to optimizing HbA1c control. In a subgroup of patients in whom improved glycaemic control leads to a reduction in cardiovascular morbidity or mortality, the use of tuned in may represent an additional preventive avenue to be considered." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes mellitus?

"There are significant barriers to the participation of minorities or individuals of low socio-economic status. Patients need to be counselled when considering clinical trials, especially in situations where the benefit of the intervention may not be anticipated by the treatment strategy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for diabetes mellitus?

"From this research a greater involvement of the insulin-mediated glucose disposal mechanisms in the pathogenesis of diabetes mellitus type 2 than of that in the early stages appears probable. The current data seem to suggest that the early-onset diabetes that can be seen in subjects with type 2 diabetes is due to a high-glucose intolerance of the islet cells." - Anonymous Online Contributor

Unverified Answer

How serious can diabetes mellitus be?

"Diabetes mellitus has a mortality rate that is threefold as high as the general population, and it has a strong association with heart disease, stroke, and peripheral nervous disease. Even when diagnosed early, most patients have severe complications by 2030. Diabetes has an enormous impact on medical care and is one of the most costly chronic diseases in the industrialized world. It is a disease that must receive attention from the health care system and the public health advocates." - Anonymous Online Contributor

Unverified Answer

How does tunedin work?

"Tunedin is a novel, novel therapeutic avenue for diabetes and insulin resistance that is being investigated in collaboration with the NIH. As of May 2014, we are planning an initial clinical trial of Tunedin in individuals who have insulin resistance and type II diabetes." - Anonymous Online Contributor

Unverified Answer

Has tunedin proven to be more effective than a placebo?

"Recent findings confirm that TCBT is an acceptable treatment with very few adverse events for treatment of diabetic ketoacidosis. We feel further evaluation of TCBT as an additional tool for the treatment of diabetic ketoacidosis and diabetic acidosis is warranted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus by sharing your contact details with the study coordinator.