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Behavioural Intervention

Behavioral Approaches for Type 1 Diabetes (ChargeUp Trial)

N/A
Recruiting
Led By Anna Kahkoska, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 30 years and older
Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
Must not have
Cannot commit to the pre-scheduled weekly, virtual sessions
Diagnosis of any major medical or psychiatric condition that would preclude participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 36 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two different methods for reducing diabetes distress in adults with type 1 diabetes. Participants will be randomly assigned to one of two virtual group interventions that focus on emotions or problem-solving. If

Who is the study for?
This trial is for adults with type 1 diabetes who are experiencing emotional distress due to the challenges of managing their condition. Participants must be comfortable engaging in virtual group sessions and completing surveys. Specific eligibility criteria details were not provided.
What is being tested?
The study compares two virtual, group-based behavioral interventions aimed at reducing diabetes-related emotional distress: ReCharge focuses on emotions, while TakeCharge uses a problem-solving approach. Non-responders get additional individualized sessions.
What are the potential side effects?
Since this trial involves behavioral approaches rather than medication, traditional physical side effects are not expected. However, participants may experience increased emotional sensitivity or stress during the intervention process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 30 years old or older.
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I have type 1 diabetes or LADA treated as type 1 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot attend weekly virtual sessions as scheduled.
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I do not have any major health or mental conditions that would stop me from joining.
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I have been diagnosed with dementia or a condition affecting my memory.
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I do not have severe vision or hearing problems that would stop me from joining group activities.
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I have not been in psychiatric hospitalization or attempted suicide in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Total Diabetes Distress (T1-DDS Total Score)
Secondary study objectives
Change in Core Diabetes Distress (T1-DDAS Core Score)
Change in Diabetes Quality of Life
Change in Diabetes Specific Self-Compassion
+9 more
Other study objectives
Intervention Satisfaction
Long-term Change in Core Diabetes Distress (T1-DDAS Core Score)
Long-term Change in Hemoglobin A1c (HbA1c)
+7 more

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
Group I: TakeChargeExperimental Treatment1 Intervention
Participants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional.
Group II: ReChargeExperimental Treatment1 Intervention
Participants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,369 Total Patients Enrolled
American Diabetes AssociationOTHER
143 Previous Clinical Trials
100,878 Total Patients Enrolled
Anna Kahkoska, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
12 Total Patients Enrolled
~133 spots leftby Sep 2027
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