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Behavioural Intervention

Behavioral Approaches for Type 1 Diabetes (ChargeUp Trial)

N/A
Waitlist Available
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
Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test ways to help adults with type 1 diabetes cope better with the challenges of living with the disease. Participants will be split into two groups to receive different types of virtual support,

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 should be willing to engage in virtual group sessions and provide feedback on their experience.
What is being tested?
The study is testing two virtual, group-based behavioral interventions named ReCharge and TakeCharge, aimed at reducing diabetes-related emotional distress. It's a pilot study where participants will be randomly assigned to one of these approaches.
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications, traditional physical side effects are not expected. However, discussing emotional issues could potentially cause temporary discomfort or heightened emotions.

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 have not been in psychiatric care or attempted suicide in the last year.
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I have been diagnosed with dementia or a condition affecting my memory.
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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 do not have severe vision or hearing problems that would stop me from joining group activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 Glycemic Variability
+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.

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,116 Total Patients Enrolled
8 Trials studying Diabetes
2,161 Patients Enrolled for Diabetes
American Diabetes AssociationOTHER
143 Previous Clinical Trials
101,066 Total Patients Enrolled
17 Trials studying Diabetes
1,664 Patients Enrolled for Diabetes
Anna Kahkoska, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
200 Total Patients Enrolled
~8 spots leftby Nov 2025
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