Self-Management Workbook for Diabetes

Overseen By Catherine Park, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Anemia, Hemoglobinopathy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create and test a workbook filled with word games to help people with diabetes learn to manage their condition, starting with carbohydrate management. Participants will use the diabetes self-management workbook either at the clinic or at home and attend follow-up sessions to track improvements in managing their diabetes. The trial seeks input from patients, caregivers, and healthcare providers to refine the workbook for broader use. Ideal candidates for this trial have type 2 diabetes, manage their condition without insulin, and maintain stable blood sugar levels. Participants should be comfortable reading English and attending follow-up visits.

As an unphased trial, this study offers a unique opportunity to contribute to developing innovative educational tools for diabetes management.

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 seems focused on using a workbook to help manage diabetes, so it's unlikely that medication changes are required.

What prior data suggests that this workbook is safe for diabetes management?

Research has shown that diabetes self-management education (DSME) is safe and effective. Studies have found that DSME helps people with type 2 diabetes understand their condition and better control their blood sugar levels. It also boosts their confidence in managing their health.

No reports of negative effects from this educational approach have emerged. The main goal is to empower people with diabetes to take charge of their health, including learning important skills like managing carbohydrates and checking blood sugar levels.

Overall, DSME is considered a safe way to help people manage diabetes, focusing on education and habit changes rather than medication or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the diabetes self-management workbook because it empowers patients to take control of their health in a simple, structured way. Unlike traditional treatments like medication or insulin therapy, which require frequent medical intervention, this workbook encourages self-guided learning and behavior change. By focusing on education and self-monitoring over a three-month period, it aims to improve long-term health outcomes and reduce reliance on more invasive methods. This approach can enhance patient engagement and potentially lead to better adherence to healthy habits, making it a promising addition to existing diabetes management strategies.

What evidence suggests that this workbook is effective for diabetes management?

Research has shown that learning to manage diabetes can significantly help people with type 2 diabetes control their condition. This trial will evaluate the effectiveness of a diabetes self-management workbook. Studies have found that educational programs like this can lead to a noticeable decrease in A1C levels, an important measure of blood sugar control. On average, participants experience a reduction in A1C of 0.45–0.57% compared to those receiving usual care. Other research has noted improvements in related health measures like weight and Body Mass Index (BMI). These findings suggest that learning effective self-management techniques can lead to better overall health for people with diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Saria Hassan, MD

Principal Investigator

Emory University

Catherine Park, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who are interested in learning how to manage their condition through a workbook. Participants should be willing to complete the workbook either at the clinic or at home and attend follow-up sessions.

Inclusion Criteria

Patients: adult with diabetes and patient at the Midtown Clinic

I don't have anemia, liver, kidney disease, or blood disorders affecting my hemoglobin.

I am a caregiver for someone with diabetes.

Exclusion Criteria

Focus group exclusion:

Pregnancy

I am not willing to participate in group discussions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Workbook Development and Use

Participants co-develop and complete a word game-based workbook to enhance diabetes self-efficacy

3 months

Workbook can be completed during clinic visits or at home

Follow-up

Participants attend follow-up sessions to assess changes in self-efficacy and glycemic control

3 months

Pre test and post test assessments

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes self management workbook

Trial Overview The study is testing a new word game-based workbook designed to help patients understand carbohydrate management as part of their diabetes care. The effectiveness, user-friendliness, and potential challenges of this educational tool will be evaluated.

How Is the Trial Designed?

Group I: Diabetes self management Experimental Treatment 1 Intervention

Eligible participants will utilize the workbook for a span of 3 months

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Center for Diabetes Translation Research

Collaborator

Trials

5

Recruited

200+

Published Research Related to This Trial

A significant increase in unintentional therapeutic errors involving insulin was observed over a 10-year period, with a 495% rise in annual incidence, particularly affecting adults over 40 years old and predominantly women.

Most of these errors occurred in non-healthcare settings, especially during late evening hours, highlighting the need for better management strategies and the importance of poison control centers as a resource for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. Spiller, HA., Borys, DJ., Ryan, ML., et al.[2011]

Diabetes conversation maps (CMs) were found to be an effective method for diabetes self-management education, leading to significant improvements in knowledge and attitudes compared to traditional group education (TE) among 21 participants.

Both education methods resulted in significant decreases in glycated hemoglobin (A1C) levels after 3 months, indicating that both approaches can effectively help manage diabetes, but CMs may enhance the educational experience and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Diabetes Self-Management Education Methods on Knowledge, Attitudes and Behaviours of Adult Patients With Type 2 Diabetes Mellitus. Adam, L., O'Connor, C., Garcia, AC.[2022]

The study developed a Diabetes Self-Management Model (DSMM) based on interviews with 18 adults with Type I diabetes, highlighting that self-management involves sequential phases influenced by personal factors and monitoring activities.

Participants emphasized the importance of individualized regimens tailored to their personal experiences, suggesting that effective diabetes management is not one-size-fits-all but rather requires adaptation to what works best for each individual.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experiential model of learning diabetes self-management. Price, MJ.[2017]

A comprehensive analysis of the National Reporting and Learning System database revealed that patient safety incidents involving insulin are common and lead to significant distress for individuals with diabetes and their families, highlighting a critical area for improvement in diabetes care.

The article discusses ongoing efforts by the National Patient Safety Agency and partner organizations aimed at reducing insulin-related errors, indicating a proactive approach to enhancing patient safety in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. Cousins, D., Rosario, C., Scarpello, J.[2021]

A study of 99 insulin-treated diabetic patients revealed that specific precautions, such as reviewing prescriptions and adhering to diet, significantly reduced treatment errors, highlighting the importance of patient engagement in their own care.

Female patients were found to be more diligent in following blood glucose monitoring instructions and using pillboxes, while male patients were more likely to carry allergy information, indicating gender differences in safety practices among diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What do diabetic patients and what should they do to avoid errors in the course of treatment?]. Mira, JJ., Lorenzo, S., Vitaller, J., et al.[2015]

Both generic and diabetes-specific self-management programs led to significant improvements in self-management knowledge and skills, as well as reductions in depression among 458 participants over a 12-week follow-up period.

Younger participants with higher self-efficacy and better health-related quality of life (HRQOL) showed the most improvement, highlighting the need to encourage participation from individuals with lower socio-economic status to avoid worsening health inequalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management programs conducted within a practice setting: who participates, who benefits and what can be learned? Packer, TL., Boldy, D., Ghahari, S., et al.[2022]

Educational interventions for healthcare professionals, including a 6-hour standardized course, significantly improved their attitudes and motivation towards monitoring diabetes, which is crucial for patient safety.

The study suggests that these interventions can enhance the control of diabetes in patients, as measured by HbA1c levels, although the specific outcomes on patient control were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. Cabré, JJ., Ripoll, M., Hernández, JM., et al.[2021]

In a study involving 5,457 low-income adults with diabetes, patient report cards were well-received but did not lead to improved clinical outcomes in glycemic control, lipid levels, or blood pressure.

However, providing targeted, patient-level performance feedback to healthcare providers resulted in a significant increase in the percentage of patients achieving glycemic control, indicating that personalized feedback can enhance provider performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of tailored diabetes registry report cards on measures of disease control: a nested randomized trial. Fischer, HH., Eisert, SL., Durfee, MJ., et al.[2023]

Patients with diabetes are responsible for 99% of their own care, highlighting the need for effective support systems and education from healthcare providers.

To improve diabetes self-management, healthcare practices must redefine the roles of health professionals and patients, and redesign systems to facilitate long-term support and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing office practice and health care systems to facilitate diabetes self-management. Funnell, MM., Anderson, RM.[2022]

A pilot intervention aimed at helping low-income, Hispanic patients with diabetes connect to community resources showed a high demand for assistance, with all participants requesting at least one referral for services like food and housing support.

Although the intervention did not result in significant changes in diabetes self-care or self-efficacy, a notable 50% of patients followed up on their referrals, indicating that connecting patients to existing resources can be an effective and low-cost strategy for improving their overall support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinic-based pilot intervention to enhance diabetes management for elderly Hispanic patients. Nguyen, AL., Angulo, M., Haghi, LL., et al.[2020]

A significant 86% of the 111 diabetes patients experienced at least one adverse event (AE) or potential adverse event (PotAE) over a 9-month period, highlighting the prevalence of safety issues in chronic disease management.

The majority of AEs (63%) were related to medication management, and 77% of events involved patient actions, indicating that enhancing patient self-management and communication with healthcare providers is crucial for preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. Sarkar, U., Handley, MA., Gupta, R., et al.[2021]

Effective diabetes management heavily relies on patients' ability to self-manage their symptoms, which is crucial for achieving positive health outcomes and improving quality of life.

Utilizing a social ecological model of behavior change can help healthcare providers implement multiple-level interventions that support and sustain self-management behaviors in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining self-management in diabetes mellitus. Mitchell-Brown, F.[2019]

A systematic review of 11 studies involving 1073 participants found that individual empowerment strategies for diabetes management, such as consultations and educational materials, did not lead to significant reductions in HbA1c levels, which is a key measure of blood sugar control.

While these strategies did show some positive effects on psychosocial factors like self-efficacy and quality of life, the lack of impact on HbA1c suggests that these approaches need to be reevaluated to enhance their effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of individual strategies for the empowerment of patients with diabetes mellitus: A systematic review with meta-analysis. Aquino, JA., Baldoni, NR., Flôr, CR., et al.[2022]

Ongoing patient education and feedback are essential for effective self-management in patients with Type 2 Diabetes Mellitus (T2DM), highlighting the importance of continuous support.

An individualized program that includes an interprofessional team of healthcare professionals and utilizes positive feedback and motivational strategies significantly enhances patient engagement and management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education and monitoring recommendations for the use of glucagon-like peptide-1 receptor agonists. Haines, ST.[2015]

A new diagnostic tool was developed for pharmacists to assess diabetes patients' readiness to adhere to diet regimens, utilizing the Transtheoretical Model (TTM) to measure stages of change, decisional balance, and self-efficacy among 193 participants.

The study found that TTM measures effectively identified factors that facilitate or hinder diet adherence, but highlighted the importance of considering social desirability bias in self-reported diet adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision making: strategies for diabetes diet adherence intervention. Kavookjian, J., Berger, BA., Grimley, DM., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... Based on 15 articles, diabetes self-management education intervention provides significant effectiveness to lifestyle changes and the self-care of T2DM patients ...

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1543298/full

Comparative effectiveness of diabetes self-management ... Results: Findings demonstrate the positive effects of all three intervention modalities (i.e., vMMWD, TBES, and combined) to significantly reduce A1c among ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352013225000729

Effectiveness of a theory-based tailored individual and ... This study aimed to determine the effectiveness of an individual and family self-management (IFSM) education program on triglyceride-glucose (TyG) index, self- ...

4. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Based on recent data (13,14,16), DSMES results in an average A1C reduction of 0.45–0.57% when compared with usual care for people with type 2 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11839741/

The Effectiveness of a Primary Care Diabetes Education and ... Our study found that participants who completed the DESMOND diabetes self‐management programme showed significant improvements in HbA1c, weight, and BMI at 6 ...

6. diabetesjournals.org diabetesjournals.org/books/book/51/chapter/5143391/Diabetes-Self-Management-Education-and-Behavior

Diabetes Self-Management Education and Behavior Change The demands of diabetes self-care require current knowledge, personal engagement, and empowerment in order to effectively assume this lifelong responsibility.

7. academic.oup.com academic.oup.com/jcem/article/110/Supplement_2/S91/8042177

Role of Diabetes Self-management Education for Our Health ... Educating people with diabetes improves outcomes and affects the economic burden on the individual and health systems.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11382828/

Effectiveness and safety of self-management interventions for ... The objective of this review was to assess and synthesize evidence on the effectiveness and safety of self-management interventions for improving glycemic ...

9. professional.diabetes.org professional.diabetes.org/sites/default/files/media/tab_9-_dsme_article.pdf

Diabetes Self-management Education and Support in Type ... Based on the patient's medication and monitoring recommendations, themes such as hypoglycemia identification and treatment, interpreting glucose results, risk ...