Behavioral Approaches for Type 1 Diabetes
(ChargeUp Trial)
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
56789How 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.
19101112Eligibility 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.
+1 more
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.
+3 more
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
Participant Groups
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
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.
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.
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.
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.
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.
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.
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.
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.
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".
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.
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.
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).