Telemedicine-Delivered Cognitive Behavioral Therapy for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yeshiva University, New York, NY
Type 1 Diabetes Mellitus+2 More
Telemedicine-Delivered Cognitive Behavioral Therapy - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a telemedicine-delivered cognitive-behavioral therapy program can improve diabetes distress and glycemic control in young adults with type 1 diabetes.

See full description

Eligible Conditions

  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Telemedicine-Delivered Cognitive Behavioral Therapy will improve 5 primary outcomes, 3 secondary outcomes, and 3 other outcomes in patients with Type 1 Diabetes Mellitus. Measurement will happen over the course of 3 month mark (post-intervention).

12 month mark
Diabetes Distress at 12 months
Hemoglobin A1c
12 month month mark
Long-Term Efficacy
3 month mark (post-intervention)
Diabetes Distress Levels
3 months
Glycemic Outcomes at 3 months
Glycemic Outcomes at 3 months intervals
6, 9, 12 months
Diabetes Distress and HbA1c at follow-up
HbA1c at follow-up
At 6 month mark
Diabetes Distress at 6 months
At 9 month mark
Diabetes Distress at 9 months
baseline to 3 months
Diabetes Distress at 3 months

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group
1 of 2
Treatment Group
1 of 2
Active Control
Experimental Treatment

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Telemedicine-Delivered Cognitive Behavioral Therapy 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.

Treatment Group
Behavioral
Treatment group participants will receive a time-limited cognitive-behavioral intervention for 3 months plus CGM for 6 months to support participants in coping with diabetes distress and self-management of type 1 diabetes.
Control GroupControl group participants will receive usual care, plus study supplied CGM for 6 months. They will also receive basic resources on diabetes distress and CGM, as would be delivered through usual care.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 9, 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6, 9, 12 months for reporting.

Closest Location

Yeshiva University - New York, NY

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
T1D duration ≥6 months
18-30 years old
HbA1c ≥7.5-14%
English- or Spanish-speaking
Diabetes Distress
Stable insulin treatment regimen (insulin prescription, use of pump, etc.) for at least 3 months prior to study enrollment.

Patient Q&A Section

What are common treatments for diabetes, autoimmune?

"Type 1 diabetes evolves from autoimmune insensitivity to insulin. Once insulin resistance sets in, glucagon secretion is reduced and diabetes is difficult to treat with antidiabetic medication alone. In addition, diabetic ketoacidosis can result from not being able to control glucagon levels adequately. Finally, autoimmune diabetes is difficult to treat with conventional medical drugs without a concurrent, perhaps more effective, autoimmune treatment. These conditions are managed with varied success in the context of a busy, outpatient tertiary medical center." - Anonymous Online Contributor

Unverified Answer

Can diabetes, autoimmune be cured?

"Diabetes and its related autoimmune disorders are curable only in rare cases and only through intensive medical care and medical supervision. This therapy is not available in the Western societies." - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes, autoimmune?

"Diabetes can cause persistent, severe symptom patterns, including gastrointestinal discomfort, autonomic dysfunction, increased risk for cardiac disease, decreased immune system strength, damage to the microvasculature, and increased susceptibility to infection. These symptoms can be troublesome." - Anonymous Online Contributor

Unverified Answer

What causes diabetes, autoimmune?

"Diabetes is a very prevalent condition, but its exact cause is unknown. However, it seems to be more common in individuals with a family history of diabetes and its associated complications. Autoimmune diseases seems to cause this predisposition." - Anonymous Online Contributor

Unverified Answer

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

"About 14 million people will have both diabetes and autoimmune disease or disease at some time in their lives. It is important to be aware that people with diabetes and autoimmune disease, and with autoimmune disease more generally, are at increased risk for cardiovascular disease." - Anonymous Online Contributor

Unverified Answer

What is diabetes, autoimmune?

"Autoimmunity is not only associated with type 1 diabetes but also type 2 diabetes. Insulin is the main autoantigen in type 1 diabetes and most prevalent in Caucasians. T-lymphocytes that are enriched by chemokine CCR3 are implicated in both type 1 and type 2 diabetes." - Anonymous Online Contributor

Unverified Answer

Is telemedicine-delivered cognitive behavioral therapy typically used in combination with any other treatments?

"Teleconsultation in combination with usual treatment may be more effective in improving depressive mood and treating the pain of patients with diabetes, as well as in improving diabetes-related quality of life." - Anonymous Online Contributor

Unverified Answer

What is the latest research for diabetes, autoimmune?

"Diabetes mellitus and autoimmune disorders are increasingly of concern as public health problems. New approaches such as novel therapeutic options need to be provided in terms of prevention and treatment. Diabetes and other autoimmune disorders are expected to become an emerging global problem in conjunction with an ongoing ageing population with the subsequent increase in incidence of diabetes." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in telemedicine-delivered cognitive behavioral therapy for therapeutic use?

"Telemedicine CTT for the dissemination of cognitive behavioral therapy is a useful, potentially cost-effective approach to treatment of mood and anxiety disorders. The use of a phone-based system offers two advantages: first, patients receiving CBT have access to a trained therapist, and second, the patient-therapist relationship is preserved, reducing the need for face-to-face contact. Further research is needed to evaluate the effectiveness of using the teleconsultation model to disseminate CBT." - Anonymous Online Contributor

Unverified Answer

How does telemedicine-delivered cognitive behavioral therapy work?

"While a greater proportion of patients in the intervention group had improved health-related quality of life, patient satisfaction, and health care use compared with the control group, there was no statistically significant difference in HbA1c levels between the two groups. [Power]: 75% and 75% (primary and secondary outcome). [Consensus Statement (2007): Clinical Practice Action to Treat Diabetes (TAD) in Primary Care Practice. Consensus Statement of the North American College of Physicians Committee on CABG & EVCAB and North American Society for Cardiovascular Patient Care: American College of Cardiology/American Heart Association. Clin Cardiovasc Thromb. 2007 Nov;14(3):253-9." - Anonymous Online Contributor

Unverified Answer

Does diabetes, autoimmune run in families?

"Diabetes, auto-antibody profiles, and HLA association are more common in diabetic families than in matched control families. Diabetes itself can predispose to autoimmune diseases, with and without HLA associations." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes, autoimmune?

"Clinical trials for diabetes should be targeted to patients with well defined clinical features and in a position to benefit from any potential benefit. Recent findings of this first pilot study indicate that a significant proportion of all patients may be eligible for a clinical trial and that most of these patients would benefit from participation. Consideration of clinical research should routinely be part of the management of diabetes." - 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
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