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.
Is the treatment ReCharge, TakeCharge a promising treatment for Type 1 Diabetes?ReCharge, TakeCharge seems promising because behavioral approaches, like this treatment, can help people with Type 1 Diabetes manage their condition better. These approaches focus on improving self-management skills, which are important for controlling diabetes.4561112
What safety data exists for the behavioral treatment for Type 1 Diabetes?The provided research does not directly mention safety data for the behavioral treatment known as ReCharge or TakeCharge. However, the ACT1ON consortium study, which involves a behavioral intervention for weight management and glycemia in Type 1 Diabetes, emphasizes the need for the intervention to be safe, feasible, and accepted by young adults with T1D. This suggests that safety considerations are part of the study design, but specific safety data is not detailed in the abstracts provided.2781011
What data supports the idea that Behavioral Approaches for Type 1 Diabetes (also known as: ReCharge, TakeCharge) is an effective treatment?The available research shows that while behavioral approaches for type 1 diabetes self-management programs are designed to help individuals manage their condition, the evidence on their effectiveness is mixed. Some studies suggest that these programs can lead to short-term improvements in managing blood sugar levels, but maintaining these improvements over the long term is challenging. For example, the DAFNE program, which is similar to ReCharge and TakeCharge, shows initial success but struggles with long-term behavior change. Additionally, a study on a behavioral medicine intervention for adults with poorly controlled diabetes found it feasible and associated with improved blood sugar control. However, the overall effectiveness of these programs compared to other treatments remains unclear.135910
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the focus is on behavioral approaches.
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
I am 30 years old or older.
I have type 1 diabetes or LADA treated as type 1 diabetes.
Exclusion Criteria
I cannot attend weekly virtual sessions as scheduled.
I do not have any major health or mental conditions that would stop me from joining.
I have been diagnosed with dementia or a condition affecting my memory.
I do not have severe vision or hearing problems that would stop me from joining group activities.
I have not been in psychiatric hospitalization or attempted suicide in the last year.
Treatment Details
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.
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 clinic near you
Research locations nearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
Loading ...
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
American Diabetes AssociationCollaborator
References
Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial. [2022]Both acute and chronic complications of diabetes account for a disproportionate percentage of US health care expenditures. Despite improvements in diabetes care, the incidence of adverse events in children with type 1 diabetes remains high, particularly for youths with poor glycemic control. Cost-effective intervention programs designed to reduce complications are needed. This study evaluated a low-intensity, nonmedical intervention using a case manager (called a "Care Ambassador"), with and without the supplementation of psychoeducational modules, designed to monitor and encourage routine diabetes care visits to reduce short-term adverse outcomes and improve glycemic control in youths with type 1 diabetes.
Long-term intervention studies using insulin in patients with type 1 diabetes. [2022]To discuss data from long-term intervention studies regarding therapy in type 1 diabetes and review strategies for preventing hypoglycemia and safely achieving glycemic goals in this patient population.
Experience from a behavioural medicine intervention among poorly controlled adult type 1 diabetes patients. [2018]To describe experience from a behavioural medicine intervention among poorly controlled adult type 1 diabetes patients, in terms of feasibility, predictors and associations of improved glycaemic control.
Patient attitudes about financial incentives for diabetes self-management: A survey. [2020]To study the acceptability of incentives for behavior changes in individuals with diabetes, comparing financial incentives to self-rewards and non-financial incentives.
Behavioral Programs for Type 1 Diabetes Mellitus: A Systematic Review and Meta-analysis. [2022]Whether behavioral approaches for self-management programs benefit individuals with type 1 diabetes mellitus is unclear.
A systematic review on incentive-driven mobile health technology: As used in diabetes management. [2022]Introduction Mobile health (mHealth) technologies have been shown to improve self-management of chronic diseases, such as diabetes. However, mHealth tools, e.g. apps, often have low rates of retention, eroding their potential benefits. Using incentives is a common mechanism for engaging, empowering and retaining patients that is applied by mHealth tools. We conducted a systematic review aiming to categorize the different types of incentive mechanisms employed in mHealth tools for diabetes management, which we defined as incentive-driven technologies (IDTs). As an auxiliary aim, we also analyzed barriers to adoption of IDTs. Methods Literature published in English between January 2008-August 2014 was identified through searching leading publishers and indexing databases: IEEE, Springer, Science Direct, NCBI, ACM, Wiley and Google Scholar. Results A total of 42 articles were selected. Of these, 34 presented mHealth tools with IDT mechanisms; Education was the most common mechanism ( n = 21), followed by Reminder ( n = 11), Feedback ( n = 10), Social ( n = 8), Alert ( n = 5), Gamification ( n = 3), and Financial ( n = 2). Many of these contained more than one IDT ( n = 19). The remaining eight articles, from which we defined barriers for adoption, were review papers and a qualitative study of focus groups and interviews. Discussion While mHealth technologies have advanced over the last five years, the core IDT mechanisms have remained consistent. Instead, IDT mechanisms have evolved with the advances in technology, such as moving from manual to automatic content delivery and personalization of content. Conclusion We defined the concept of IDT to be core features designed to act as motivating mechanisms for retaining and empowering users. We then identified seven core IDT mechanisms that are used by mHealth tools for diabetes management and classified 34 articles into these categories.
A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. [2023]While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system.
Rationale and protocol for the After Diabetes Diagnosis REsearch Support System (ADDRESS): an incident and high risk type 1 diabetes UK cohort study. [2022]Type 1 diabetes is heterogeneous in its presentation and progression. Variations in clinical presentation between children and adults, and with ethnic group warrant further study in the UK to improve understanding of this heterogeneity. Early interventions to limit beta cell damage in type 1 diabetes are undergoing evaluation, but recruitment is challenging. The protocol presented describes recruitment of people with clinician-assigned, new-onset type 1 diabetes to understand the variation in their manner of clinical presentation, to facilitate recruitment into intervention studies and to create an open-access resource of data and biological samples for future type 1 diabetes research.
Sustained type 1 diabetes self-management: Specifying the behaviours involved and their influences. [2022]Sustained engagement in type 1 diabetes self-management behaviours is a critical element in achieving improvements in glycated haemoglobin (HbA1c) and minimising risk of complications. Evaluations of self-management programmes, such as Dose Adjustment for Normal Eating (DAFNE), typically find that initial improvements are rarely sustained beyond 12 months. This study identified behaviours involved in sustained type 1 diabetes self-management, their influences and relationships to each other.
The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. [2022]Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change.
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]Young adults with type 1 diabetes (T1D) often have difficulty co-managing weight and glycemia. The prevalence of overweight and obesity among individuals with T1D now parallels that of the general population and contributes to dyslipidemia, insulin resistance, and risk for cardiovascular disease. There is a compelling need to develop a program of research designed to optimize two key outcomes-weight management and glycemia-and to address the underlying metabolic processes and behavioral challenges unique to people with T1D. For an intervention addressing these dual outcomes to be effective, it must be appropriate to the unique metabolic phenotype of T1D, and to biological and behavioral responses to glycemia (including hypoglycemia) that relate to weight management. The intervention must also be safe, feasible, and accepted by young adults with T1D. In 2015, we established a consortium called ACT1ON: Advancing Care for Type 1 Diabetes and Obesity Network, a transdisciplinary team of scientists at multiple institutions. The ACT1ON consortium designed a multi-phase study which, in parallel, evaluated the mechanistic aspects of the unique metabolism and energy requirements of individuals with T1D, alongside a rigorous adaptive behavioral intervention to simultaneously facilitate weight management while optimizing glycemia. This manuscript describes the design of our integrative study-comprised of an inpatient mechanistic phase and an outpatient behavioral phase-to generate metabolic, behavioral, feasibility, and acceptability data to support a future, fully powered sequential, multiple assignment, randomized trial to evaluate the best approaches to prevent and treat obesity while co-managing glycemia in people with T1D. Clinicaltrials.gov identifiers: NCT03651622 and NCT03379792. The present study references can be found here: https://clinicaltrials.gov/ct2/show/NCT03651622 https://clinicaltrials.gov/ct2/show/NCT03379792?term=NCT03379792&draw=2&rank=1 Submission Category: "Study Design, Statistical Design, Study Protocols".
Integrating psychosocial and behavioral interventions into type 1 diabetes care. [2023]To identify recent literature evaluating the efficacy of psychosocial and behavioral interventions for people with type 1 diabetes (T1D).