What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy and continuous glucose monitoring (CGM). Insulin therapy can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions. CGM can lead to skin irritation or discomfort at the sensor insertion site. mHealth interventions, like the iACT trial, which focus on improving glycemic control and addressing eating disorder symptoms, may also involve psychological impacts such as increased anxiety or stress related to constant monitoring and data tracking. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes that focus on glycemic control, including insulin therapies and advanced insulin delivery systems like hybrid closed-loop insulin delivery. While specific mHealth interventions for T1D are not detailed, behavioral and psychological support are often integrated into diabetes management programs to address issues such as eating disorders. These comprehensive approaches aim to improve both glycemic control and overall well-being in T1D patients.

What other types of research exist?

Promising novel alternatives to iACT for Type 1 Diabetes patients include: 1) Autologous Hematopoietic Stem Cell Transplantation (AHSCT), which can lead to prolonged remission in up to 50% of patients. 2) Automated Insulin Delivery (AID) systems, such as the Tandem Control IQ, which have shown efficacy in improving glycemic control even in patients missing meal boluses. 3) Telemedicine interventions, which have demonstrated modest reductions in A1C and improved diabetes management through remote monitoring and virtual care.

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Behavioral Intervention

iACT for Type 1 Diabetes with Eating Disorders

N/A

Recruiting

Led By Rhonda Merwin, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Type 1 diabetes

16-50 years of age

Must not have

Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 39 months from start of enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new mobile app called iACT to help people aged 16-45 who have type 1 diabetes and binge-purge eating disorders. The app aims to improve blood sugar control and reduce eating disorder symptoms by offering support and management tools. The iACT app has been previously used to facilitate the application of ACT skills in diabetes management.

Who is the study for?

This trial is for people aged 16-50 with Type 1 Diabetes who also struggle with eating disorders like bulimia or binge eating. They must manage their diabetes independently and not have a history of substance abuse, psychosis, suicidal behavior, certain other eating disorders, or be non-English speakers.

What is being tested?

The study tests iACT, a mobile health intervention against usual care to see which helps better with glycemic control in Type 1 Diabetics with eating disorders. Participants will be randomly assigned to one of the two groups and monitored over nine months.

What are the potential side effects?

Since iACT is a behavioral intervention using mobile technology rather than medication, it may not have typical drug side effects but could include emotional distress or discomfort from confronting disordered eating behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 1 diabetes.

Select...

I am between 16 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 39 months from start of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~39 months from start of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 39 months from start of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability as measured by meeting the recruitment target for the study

Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire

Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey

+4 more

Secondary study objectives

Change in NIH PROMIS Scale - Anxiety

Change in NIH PROMIS Scale - Depression

Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iACT Experimental InterventionExperimental Treatment1 Intervention

Group II: Usual CareActive Control1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1DM) include insulin therapy and behavioral interventions. Insulin therapy replaces the insulin that the body can no longer produce, helping to maintain blood glucose levels within a normal range and preventing complications. Behavioral interventions, such as those studied in the iACT trial, aim to improve glycemic control by addressing psychological factors and promoting better diabetes self-management. These can include structured education, cognitive-behavioral therapy, and mobile health (mHealth) tools that provide real-time feedback and support. Combining these treatments is crucial for T1DM patients as it helps achieve optimal glycemic control and addresses the psychological and behavioral aspects of living with diabetes, thereby improving overall quality of life.

Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group.Recent Updates on Type 1 Diabetes Mellitus Management for Clinicians.Combination therapy for preservation of beta cell function in Type 1 diabetes: new attitudes and strategies are needed!