Behavioral Approaches for Type 1 Diabetes

(ChargeUp Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Anna Kahkoska, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Major medical, Psychiatric, Dementia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.

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.

What data supports the effectiveness of the treatment ReCharge, TakeCharge for type 1 diabetes?

Research shows that behavioral programs can help people with type 1 diabetes manage their condition better, although maintaining these improvements over time can be challenging. Programs like DAFNE have shown short-term benefits in managing blood sugar levels, suggesting that similar behavioral approaches might be effective. ^{1 2 3 4 5}

Is the behavioral approach for type 1 diabetes safe for humans?

The studies reviewed focus on self-management and behavioral interventions for type 1 diabetes, emphasizing the need for safe and feasible approaches. While specific safety data for ReCharge or TakeCharge is not mentioned, the interventions are designed to be safe and accepted by participants. ^{5 6 7 8 9}

How does the ReCharge, TakeCharge treatment for Type 1 Diabetes differ from other treatments?

ReCharge, TakeCharge is unique because it focuses on behavioral approaches to manage Type 1 Diabetes, integrating psychosocial and behavioral interventions to improve self-management, unlike traditional treatments that primarily focus on medication and insulin therapy. ^{1 9 10 11 12}

Research Team

Anna Kahkoska, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• ReCharge (Behavioural Intervention)
• TakeCharge (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Charles D. Henderson

American Diabetes Association

Chief Executive Officer since 2020

Bachelor's degree from Texas A&M University

Osagie Ebekozien

American Diabetes Association

Chief Medical Officer since 2024

MD, MPH, CPHQ

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 1 Diabetes Mellitus: A Systematic Review and Meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Sustained type 1 diabetes self-management: Specifying the behaviours involved and their influences. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Experience from a behavioural medicine intervention among poorly controlled adult type 1 diabetes patients. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. [2022]

6. England 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. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

A systematic review on incentive-driven mobile health technology: As used in diabetes management. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Integrating psychosocial and behavioral interventions into type 1 diabetes care. [2023]