Behavioral Approaches for Type 1 Diabetes

(ChargeUp Trial)

Overseen By Angela Fruik, MPH, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Major medical, Psychiatric, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two group-based methods to help adults with type 1 diabetes manage stress related to the condition. Participants will join either the TakeCharge group, which focuses on problem-solving, or the ReCharge group, which centers on handling emotions. If the initial approach proves ineffective, participants will receive additional, more personalized support. This trial may suit those with type 1 diabetes or latent autoimmune diabetes in adults (LADA) who feel overwhelmed by managing their condition. As an unphased study, this trial offers a unique opportunity to explore innovative stress management techniques tailored to participants' needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral approaches to reduce diabetes distress.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ReCharge program, which focuses on emotions, has been studied before. Results from similar programs demonstrated positive effects, such as better family involvement in managing diabetes and improved blood sugar control. People generally find these programs helpful for managing stress related to diabetes.

For TakeCharge, which uses a problem-solving approach, similar programs have also shown benefits. Studies found that these programs can reduce diabetes-related stress and improve diabetes management. Although the overall impact of these programs is considered small to medium, they remain helpful.

Both ReCharge and TakeCharge are behavioral programs, focusing on changing behaviors and coping strategies instead of using medication. This approach is usually safe and well-tolerated. Participants typically report positive outcomes with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Approaches for Type 1 Diabetes trial because it explores new ways to support people with diabetes through problem-solving and emotional guidance. Unlike conventional treatments that focus on insulin management and monitoring blood sugar levels, the TakeCharge approach offers a problem-solving intervention led by diabetes care professionals to help patients manage their daily challenges. Meanwhile, ReCharge provides an emotions-focused intervention facilitated by mental health professionals, addressing the emotional and psychological aspects of living with diabetes. These innovative approaches aim to enhance overall well-being and empower patients in managing their condition beyond traditional medical treatments.

What evidence suggests that this trial's treatments could be effective for reducing diabetes distress?

This trial will compare two behavioral approaches for managing type 1 diabetes: the ReCharge and TakeCharge programs. Research has shown that non-drug treatments can enhance life for people with type 1 diabetes by reducing anxiety and helping control blood sugar levels (HbA1c). Participants in the ReCharge program, which focuses on emotions, will benefit from studies showing that positive thinking can lower diabetes-related stress. Meanwhile, the TakeCharge program, which emphasizes problem-solving, is supported by findings that online programs can improve health measures like blood sugar, weight, and cholesterol. Both programs aim to help people manage the emotional and practical challenges of living with diabetes, potentially easing the burden by addressing both emotional and practical needs. ^{6 7 8 9 10}

Who Is on the Research Team?

Anna Kahkoska, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English speaking

I am 30 years old or older.

I have type 1 diabetes or LADA treated as type 1 diabetes.

Exclusion Criteria

Does not receive diabetes care at UNC Endocrinology at Eastowne

I cannot attend weekly virtual sessions as scheduled.

I do not have any major health or mental conditions that would stop me from joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Intervention

Participants are randomized to either the ReCharge or TakeCharge intervention for 5 weeks

5 weeks

Virtual group sessions

Supplementary Intervention

Non-responders to the Primary Intervention are re-randomized to a Supplementary Intervention for 5 weeks

5 weeks

3 virtual, individualized sessions

Follow-up

Participants are monitored for changes in diabetes distress and other outcomes

12 weeks

Long-term Follow-up

Long-term monitoring of diabetes distress and glycemic control

24-36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ReCharge
• TakeCharge

Trial Overview 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.

How Is the Trial Designed?

Group I: TakeCharge Experimental Treatment 1 Intervention

Participants randomized to TakeCharge will participate in a problem-solving focused intervention facilitated by a diabetes care professional.

Group II: ReCharge Experimental Treatment 1 Intervention

Participants randomized to ReCharge will participate in an emotions-focused intervention facilitated by a mental health professional.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

A national survey of 153 adults with diabetes revealed that 96% were interested in financial incentives to improve their self-management, indicating a strong willingness to use monetary rewards for behavior change.

The study found that the perceived challenge of diabetes self-management tasks influenced the likelihood of using financial incentives, with participants expecting relatively modest amounts of money to motivate significant weight loss (e.g., $258 for a 5 lb loss).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient attitudes about financial incentives for diabetes self-management: A survey. Blondon, KS.[2020]

A systematic review of 42 articles identified seven core incentive mechanisms used in mobile health (mHealth) tools for diabetes management, with education being the most common, followed by reminders and feedback.

Despite advancements in technology, the fundamental incentive-driven mechanisms have remained consistent, evolving mainly in terms of content delivery and personalization to enhance user engagement and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on incentive-driven mobile health technology: As used in diabetes management. de Ridder, M., Kim, J., Jing, Y., et al.[2022]

Behavioral self-management programs for individuals with type 1 diabetes showed a moderate reduction in glycated hemoglobin (HbA1c) levels at 6 months compared to usual care, indicating short-term benefits for glycemic control.

However, at the end of the intervention and after 12 months, there were no significant differences in HbA1c levels or quality of life compared to usual care, suggesting that the long-term efficacy of these programs may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 1 Diabetes Mellitus: A Systematic Review and Meta-analysis. Pillay, J., Armstrong, MJ., Butalia, S., et al.[2022]

The revised DAFNEplus intervention for type 1 diabetes incorporates 27 new behavior change techniques to better support long-term self-management, addressing 34 identified barriers and 5 enablers to maintaining healthy behaviors.

This systematic approach involved stakeholder consultation and resulted in a comprehensive program that includes group learning, individual follow-ups, and technological support, aiming to enhance the sustainability of behavior changes post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. Stanton-Fay, SH., Hamilton, K., Chadwick, PM., et al.[2022]

Young adults with type 1 diabetes (T1D) face challenges in managing both weight and blood sugar levels, leading to increased risks of obesity-related health issues, necessitating tailored interventions.

The ACT1ON consortium has developed a comprehensive study to explore the unique metabolic needs of individuals with T1D while implementing a behavioral intervention aimed at improving weight management and glycemia, setting the stage for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes. Corbin, KD., Igudesman, D., Addala, A., et al.[2023]

Psychosocial and behavioral interventions for individuals with type 1 diabetes (T1D) generally improve well-being and can positively affect glycemic control, especially when behavioral health providers are integrated into routine care.

Group interventions, whether virtual or in-person, have shown benefits in reducing diabetes distress and depressive symptoms, although they have limited effects on improving positive parenting skills, highlighting the need for more targeted research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating psychosocial and behavioral interventions into type 1 diabetes care. Pyatak, EA., Khurana, AR.[2023]

Long-term studies indicate that intensive insulin therapy, particularly using rapid- and long-acting insulin analogues, can improve glycemic control in type 1 diabetes while also reducing the risk of hypoglycemia.

Continuous subcutaneous insulin infusion with an insulin pump is the most physiologic insulin delivery method, but insulin glargine is a viable alternative that can also help maintain safe glycemic levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term intervention studies using insulin in patients with type 1 diabetes. Bolli, GB.[2022]

The study identified 150 distinct behaviors essential for sustained self-management of type 1 diabetes, categorized into Routine, Reactive, and Reflective cycles, which are crucial for improving long-term health outcomes.

It highlighted 34 barriers and 5 enablers affecting these self-management behaviors, emphasizing the need to address these factors to enhance diabetes management programs and ultimately improve clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained type 1 diabetes self-management: Specifying the behaviours involved and their influences. Hamilton, K., Stanton-Fay, SH., Chadwick, PM., et al.[2022]

This study aims to recruit individuals with new-onset type 1 diabetes, including children and adults, to better understand the variations in clinical presentation and facilitate participation in future intervention studies.

Participants will provide clinical and demographic data, along with optional blood samples for research, creating a valuable resource for ongoing studies on type 1 diabetes and potential immunotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and protocol for the After Diabetes Diagnosis REsearch Support System (ADDRESS): an incident and high risk type 1 diabetes UK cohort study. Walkey, HC., Kaur, A., Bravis, V., et al.[2022]

A 2-year study involving 299 youths with type 1 diabetes showed that a nonmedical intervention using a 'Care Ambassador' significantly increased routine diabetes care visits compared to standard care.

The addition of psychoeducational modules to the Care Ambassador program led to a 25% reduction in total hypoglycemic events and a 60% reduction in severe hypoglycemic events, particularly benefiting high-risk youths by improving their glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial. Svoren, BM., Butler, D., Levine, BS., et al.[2022]

A behavioral medicine intervention for 94 poorly controlled adult type 1 diabetes patients was feasible, with a participation rate of 41% and a 24% attrition rate, indicating that the program could be implemented effectively.

Despite the feasibility of the intervention, the study found no significant predictors or associations that led to improved glycaemic control (HbA1c), suggesting that further research is needed to understand how to enhance metabolic outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience from a behavioural medicine intervention among poorly controlled adult type 1 diabetes patients. Amsberg, S., Anderbro, T., Wredling, R., et al.[2018]

In a 12-month randomized controlled trial involving 92 adolescents with type 1 diabetes, the diabetes self-management app 'bant' did not show significant changes in overall clinical outcomes like HbA1c compared to usual care.

However, for participants using self-monitoring of blood glucose (SMBG) at least 5 times daily, there was a notable improvement in HbA1c by 0.58%, suggesting that increased engagement with the app may enhance glycemic control in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. Goyal, S., Nunn, CA., Rotondi, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5484309/

A systematic review of interventions to improve outcomes ... This review has highlighted a lack of high‐quality, well‐designed interventions, aimed at improving health outcomes for young adults with Type 1 diabetes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12022529/

Effectiveness of Telemedicine-Delivered Carbohydrate ... The findings demonstrated a significant increase in TIR, with a mean improvement of 9.59% (95% CI 6.50% to 12.67%). Moreover, TM-based CC interventions ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420301646

THR1VE! Positive psychology intervention to treat diabetes ... The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes.

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/3/371/157865/ROCKET-T1D-Remote-Patient-Monitoring-Program

ROCKET T1D Remote Patient Monitoring Program The Launch phase of the ROCKET T1D RPM program was effective in improving diabetes self-management habits in patients with new-onset type 1 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1976131724000082

Effectiveness of Non-pharmacological Interventions for ... Non-pharmacological interventions have shown effectiveness in improving the HbA1c, quality of life, and anxiety in adolescents with type 1 diabetes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5724567/

Evidence-Based Behavioral Interventions to Promote ... Key outcomes included decreased family conflict, increased parent involvement in diabetes management, and improved glycemic control up to 2 years ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11531369/

Addressing Emotional Distress to Improve Outcomes in Adults ... Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06912737

Group Emotion-Focused Behavioral Intervention for ... In this project we seek to take our one-to-one intervention, now adapted to a group intervention (G-EFBI) and collect feasibility, acceptability, and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666776224003740

Safety of a co-designed cognitive behavioural therapy ... There is no effective intervention that integrates type 1 diabetes and eating disorders treatment for those with mild to moderate presentations of T1DE in the ...

10. diabetes.org diabetes.org/newsroom/behavioral-health-interventions-positively-impact-adults-youth-experiencing-diabetes-distress

Behavioral Health Interventions Positively Impact Adults ... Results from two studies evaluating the impact of mental health support for diabetes patients found significant benefits in patient outcomes.