Diabetes Education for Type 1 Diabetes

(T1DES Trial)

Not currently recruiting at 1 trial location

Overseen By Teaniese L Davis, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Cognitive impairment, Visual impairment, Diabetes complications

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

Compensation: Varies

Number of Visits: 7

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a customized diabetes education program, called T1DES (Type 1 Diabetes Education and Support), can help Black young adults manage type 1 diabetes by addressing emotional challenges linked to the condition. Participants will either receive traditional diabetes education or try the new T1DES program. The trial is open to Black or African American individuals aged 18-30 who are members of Kaiser Permanente Georgia, have type 1 diabetes with recent hemoglobin A1c levels above 7.5, and can use a cell phone for communication.

As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes education tailored to the community.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the T1DES intervention is safe?

Research shows that the T1DES program for diabetes education is specifically designed for young Black adults with type 1 diabetes. This program aims to reduce diabetes-related stress and improve participants' condition management. The study is in the "Not Applicable" phase, focusing on the program's practicality rather than testing a new drug or medical procedure.

Since T1DES emphasizes education and emotional support, it is expected to be safe. Similar programs have not raised safety concerns, as they do not involve medication or medical procedures. Instead, they focus on teaching and providing emotional support, which typically do not cause negative effects.

Although specific data on T1DES is not yet available, the educational nature of the program suggests it is unlikely to pose safety risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for type 1 diabetes because they focus on improving patient outcomes through education and emotional regulation, rather than just medication. The Diabetes Education arm provides traditional education, which is crucial for understanding and managing diabetes effectively. Meanwhile, the T1DES intervention is unique because it incorporates emotion regulation techniques, aiming to help patients manage the psychological challenges associated with type 1 diabetes. This focus on emotional well-being is a fresh approach, potentially improving both mental and physical health outcomes for individuals with type 1 diabetes.

What evidence suggests that this trial's treatments could be effective for diabetes distress in Black young adults with type 1 diabetes?

Research has shown that diabetes education programs can boost confidence in managing type 1 diabetes. In this trial, participants will join different groups to assess the effectiveness of these programs. One group will receive traditional diabetes education, while another will receive the T1DES intervention, tailored to cultural needs and potentially reducing diabetes-related stress, particularly in Black young adults. Addressing stress is crucial, as it can complicate blood sugar control. By focusing on emotional and cultural needs, T1DES aims to enhance diabetes management and overall health. Although more research is needed, early results suggest this approach could effectively manage type 1 diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Teaniese L Davis, PhD, MPH

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This study is for Black young adults aged 18-30 with Type 1 diabetes, who have a Hemoglobin A1c level over 7.5, can read English, and are members of Kaiser Permanente Georgia or Grady Health Systems. They must be able to text and give informed consent. Those with severe diabetes complications or cognitive impairments that prevent informed consent cannot join.

Inclusion Criteria

A cell phone able to send/receive text messages

You are a member of Kaiser Permanente Georgia or a patient at Grady Health Systems when you join.

Your blood sugar level (Hemoglobin A1c) is higher than 7.5 when you join the study.

Exclusion Criteria

Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent

My diabetes complications won't stop me from joining the study.

I have a visual, hearing, or physical disability that makes it hard for me to join group or web sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditional diabetes education or the T1DES intervention, attending 5 sessions over 3 months

3 months

5 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in HbA1c and diabetes distress at 3-months and 6-months post-baseline

6 months

2 follow-up assessments (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Education
• T1DES

Trial Overview The trial is testing T1DES, a culturally tailored educational support program designed to address diabetes distress among Black patients with Type 1 diabetes. It aims to see if this intervention improves their management of the condition compared to usual care.

How Is the Trial Designed?

Group I: T1DES Experimental Treatment 1 Intervention

Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.

Group II: Diabetes Education Active Control 1 Intervention

Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

A structured program led by certified diabetes educators significantly reduced hemoglobin A1c (HbA1c) levels in children with type 1 diabetes (T1D) during the first 18 months after diagnosis, indicating improved short-term management of the disease.

However, the benefits of this program were not observed in families with lower socioeconomic status, suggesting that additional support may be needed for these families to achieve similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured 1-year education program for children with newly diagnosed type 1 diabetes improves early glycemic control. Hawkes, CP., Willi, SM., Murphy, KM.[2022]

A compact, cost-effective education program (CEPT1) for children and adolescents with type 1 diabetes was found to be as effective as a long-term education program in improving metabolic control, as measured by glycated hemoglobin A1c (HbA1c) levels.

In a per-protocol analysis, CEPT1 showed a greater reduction in HbA1c levels (-2.3%) compared to the long-term program (-1.8%), suggesting that CEPT1 could be a more effective and resource-friendly option for diabetes education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of a compact vs a conventional, long-term education program on metabolic control in children and adolescents with type 1 diabetes: A pilot, randomized clinical trial. Geremia, C., Fornari, A., Tschiedel, B.[2022]

Dietitians in Sweden recognize the benefits of group-based education for individuals with Type 1 diabetes (T1DM), noting that it fosters a supportive environment for learning and sharing experiences.

However, they face challenges in tailoring the complexity of information to diverse group needs and lack a structured framework for assessing the effectiveness of these educational sessions, highlighting the need for improved training and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietitians' perspectives on challenges and prospects for group-based education to adults with type 1 diabetes - a qualitative study. Cairns, SR., Sjöström, ES.[2022]

A study involving 54 adolescents and young adults with type 1 diabetes in Cameroon showed that patient education via WhatsApp significantly improved diabetes knowledge in the intervention group, increasing their scores from 13/20 to 16/20 after 2 months.

The intervention group also experienced a reduction in acute complications from 28% to 16%, while the control group saw an increase in complications, highlighting the potential of digital education tools in managing diabetes, despite no change in overall glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of patient education through a social network in young patients with type 1 diabetes in a Sub-Saharan context. Sap, S., Kondo, E., Sobngwi, E., et al.[2019]

A 5-day structured education program for Type 1 diabetes significantly improved diabetes control, with a notable reduction in glycated hemoglobin (HbA1c) by 0.42% in 63 patients after one year, especially among those with initially high HbA1c levels.

The program also led to a significant decrease in severe hypoglycemia incidents, dropping from 10 episodes in the year prior to just 1 episode after the course, alongside improvements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. Rogers, H., Turner, E., Thompson, G., et al.[2022]

In 2013, only 32.31% of the 21,871 pediatric patients with type 1 diabetes in Germany and Austria received diabetes education, with younger patients receiving more frequent training, especially during their first year of diagnosis.

Acute complications like severe hypoglycemia or ketoacidosis led to an increase in diabetes training sessions, suggesting that education is often reactive rather than proactive in managing diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current practice of diabetes education in children and adolescents with type 1 diabetes in Germany and Austria: analysis based on the German/Austrian DPV database. Konrad, K., Vogel, C., Bollow, E., et al.[2018]

A study involving 14 patients with type 1 diabetes and 11 healthcare providers highlighted that effective education and support for exercise are influenced by both patient engagement and the consistency of information from care providers.

To improve exercise support for patients with type 1 diabetes, any educational program should be tailored to individual patient needs, delivered early after diagnosis, and include peer stories to enhance relatability, while also ensuring healthcare staff receive proper training to provide consistent advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. Litchfield, I., Andrews, RC., Narendran, P., et al.[2021]

In a study of 105 caregivers of children and adolescents with type 1 diabetes, higher caregiver knowledge was linked to better metabolic control, as indicated by HbA1c levels.

Interestingly, caregivers with lower educational levels had poorer knowledge scores but their children had lower HbA1c levels, suggesting that greater involvement in care may compensate for knowledge deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of diabetes education on type 1 diabetes mellitus control in children. Alonso Martín, DE., Roldán Martín, MB., Álvarez Gómez, MÁ., et al.[2022]

The DAFNE structured education program led to a significant initial reduction in HbA(1c) levels from 71 mmol/mol (8.6%) at baseline to 65 mmol/mol (8.1%) after one year, with a sustained reduction of 3 mmol/mol (0.3%) after seven years, indicating long-term benefits in glycaemic control.

Participants in the DAFNE program did not experience significant weight gain compared to a matched control group, suggesting that the program can improve diabetes management without negatively impacting weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycaemic control and weight 7 years after Dose Adjustment For Normal Eating (DAFNE) structured education in Type 1 diabetes. Gunn, D., Mansell, P.[2022]

Effective diabetes education is crucial for type-I diabetic patients, as it empowers them to self-manage their condition and achieve better metabolic control.

Studies have shown that well-structured diabetes education programs can significantly enhance long-term metabolic control and reduce acute complications, highlighting the importance of patient involvement in their own care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of education of the diabetic. Quality control in diabetes therapy]. Berger, M., Mühlhauser, I., Jörgens, V.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05735340

Type 1 Diabetes Education and Support Study (T1DES) Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years ...

2. reporter.nih.gov reporter.nih.gov/project-details/10827441

davis, teaniese latham - NIH RePORTER Evaluating the feasibility of Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress among Black young adults. Project ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06494722

Expansion of the T1DES Pilot to a Public Hospital Evaluating the Feasibility of Type 1 Diabetes Education and Support (T1DES) Intervention to Improve Diabetes Distress Among Black Young Adults. Conditions.

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596323000660

Effects of an educational program on self-efficacy towards ... To assess the effectiveness of a diabetes education program on self-efficacy towards type 1 diabetes mellitus among parents of young children and adolescents.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9346983/

Safety and Glycemic Outcomes With a Tubeless Automated ... Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase.

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

Safety of a co-designed cognitive behavioural therapy ... STEADY is a complex intervention for people with type 1 diabetes and mild-to-moderate disordered eating (T1DE) integrating cognitive behavioural therapy (CBT) ...

8. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/305-OR/158741/305-OR-Tirzepatide-in-Type-1-Diabetes-Safety

305-OR: Tirzepatide in Type 1 Diabetes—Safety, Tolerability ... Conclusion: Tirzepatide showed promising results in terms of safety, tolerability, and clinical benefits in people with T1D. Definitive data ...

9. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/type-1-diabetes

Type 1 Diabetes Clinical Trials A Study Comparing the Effectiveness and Safety of the Morning Injection of Toujeo versus Lantus in Patients with Type 1 Diabetes Mellitus Rochester, MN.