Diabetes Education for Type 1 Diabetes

Overseen By Teaniese L Davis, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Developmental delay, Visual impairment, others

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

Compensation: Varies

Number of Visits: 7

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help Black young adults aged 18-30 manage type 1 diabetes more effectively. It focuses on a treatment called T1DES (Type 1 Diabetes Education and Support), designed to aid emotional regulation and improve diabetes management outcomes. The trial compares T1DES with traditional diabetes education to determine which is more effective. Ideal participants have had type 1 diabetes for some time, have a hemoglobin A1c level over 7.5 (a measure of blood sugar control), and are patients at Grady Health System who identify as Black or African American. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies tailored for the Black community.

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.

What prior data suggests that the T1DES intervention is safe?

Research has shown that the T1DES program is being tested to assess its impact on diabetes outcomes in Black young adults with type 1 diabetes. T1DES provides education and support, not medication, and is generally considered safe. No reports of physical side effects exist. Instead, the program helps participants manage emotions and stress by discussing their feelings. This support is typically well-received and aims to enhance mental well-being. Any safety concerns might involve discomfort during discussions, but trained professionals usually manage these risks effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Education for Type 1 Diabetes trial because it explores the potential of a new emotion regulation intervention, T1DES, which is different from traditional diabetes education. While standard treatments focus primarily on managing blood sugar levels through medication and lifestyle changes, T1DES aims to address the emotional and psychological aspects of living with type 1 diabetes. This approach might help participants manage stress and emotional challenges, potentially leading to better overall diabetes management. By examining both emotional and educational strategies, researchers hope to discover new ways to improve quality of life for those 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 the T1DES program, which participants in one arm of this trial will receive, might help reduce diabetes-related stress in Black young adults with type 1 diabetes. Studies have found that diabetes education programs, which participants in another arm of this trial will receive, can enhance confidence in managing type 1 diabetes, leading to better health outcomes, such as improved blood sugar levels. While specific data on T1DES is still being gathered, the program focuses on culturally tailored support to address the unique challenges faced by this group. Overall, these types of programs show promise for improving both the emotional and physical aspects of diabetes care. ^{1 5 6 7 8}

Who Is on the Research Team?

Teaniese L Davis, PhD

Principal Investigator

Kaiser Permanente Georgia

Are You a Good Fit for This Trial?

This trial is for Black patients aged 18-30 with Type 1 Diabetes, who are Grady Health System patients, have a Hemoglobin A1c > 7.5, and can text on a cell phone. They must be able to read English and consent to the study. It excludes those with cognitive impairments or severe physical disabilities that hinder participation.

Inclusion Criteria

Grady Health System Patient

Hemoglobin A1c > 7.5 at time of enrollment

A cell phone able to send/receive text messages

Exclusion Criteria

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

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

I do not have severe diabetes complications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment before starting the intervention

1 week

Intervention

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

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-intervention

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 study tests T1DES, a culturally tailored intervention designed to reduce diabetes distress among young Black adults with Type 1 Diabetes. The goal is to see if it improves their diabetes management compared to standard diabetes education.

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+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Grady Memorial Hospital

Collaborator

Trials

5

Recruited

8,500+

Published Research Related to This Trial

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 programme significantly improves diabetes management outcomes, such as HbA1c levels and rates of severe hypoglycaemia, for up to 12 months after completion, highlighting its efficacy in educating individuals with Type 1 diabetes.

This study compares group follow-up versus traditional one-to-one visits for DAFNE graduates, aiming to determine the best method to maintain the benefits of the programme, with outcomes measured at 6, 12, and 18 months to ensure comprehensive evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. Dinneen, SF., O' Hara, MC., Byrne, M., et al.[2023]

A study involving 100 type 1 diabetes patients and 93 of their parents identified that the highest educational needs were related to managing complications, understanding disease characteristics, and exercise.

There were notable differences in educational needs between patients and parents, particularly in areas like complication management and psychosocial support, with social life being a key concern for effective disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational needs of people with type 1 diabetes mellitus and their parents: A cross-sectional study. Cho, MK., Kim, MY.[2023]

Family-centred education significantly improved treatment adherence in patients with Type 1 Diabetes Mellitus, as shown by a notable increase in adherence scores after 12 educational sessions (p < 0.001).

The intervention also led to significant reductions in both Fasting Blood Glucose and Glycosylated Hemoglobin A1C levels in the intervention group, indicating better overall diabetes management (p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does family-centred education improve treatment adherence, glycosylated haemoglobin and blood glucose level in patients with type 1 diabetes? A randomized clinical trial. Mansour, M., Parizad, N., Hemmati Maslakpak, M.[2023]

A study involving 101 individuals with type 1 diabetes from 13 countries highlighted the importance of both initial and ongoing diabetes education, emphasizing that the content (what is taught) and the process (how it is taught) are crucial for effective management of the condition.

The research identified tangible elements (specific skills and information) and intangible elements (context-specific factors related to healthcare professionals) as key components of diabetes education, suggesting that while health systems can provide structured education, addressing the intangible aspects is essential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial versus ongoing education: Perspectives of people with type 1 diabetes in 13 countries. Beran, D., Golay, A.[2018]

A study involving 30 type 1 diabetes patients revealed that many struggle with self-management due to significant gaps in their knowledge about the condition, influenced by factors like age at diagnosis and transitions in care.

The research highlights the need for individualized and ongoing education tailored to address the specific reasons behind patients' knowledge deficits, ensuring they receive consistent and comprehensive information throughout their diabetes management journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding information and education gaps among people with type 1 diabetes: a qualitative investigation. Rankin, D., Heller, S., Lawton, J.[2022]

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]

The KICk-OFF education course significantly improved quality of life scores in young people with Type 1 diabetes at 6 and 12 months compared to usual care, indicating its positive impact on psychological outcomes.

However, the course did not lead to significant changes in glycaemic control (HbA1c levels) after 24 months, suggesting that while the program benefits quality of life, it may not directly affect blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Kids in Control of Food (KICk-OFF) structured education course for 11-16 year olds with Type 1 diabetes. Price, KJ., Knowles, JA., Fox, M., et al.[2022]

Participation in the Dose Adjustment for Normal Eating (DAFNE) course led to a significant reduction in glycated hemoglobin (HbA1c) levels from 8.2% to 7.8% over one year, indicating improved glycaemic control in 145 participants with type 1 diabetes.

The DAFNE program also resulted in a decrease in the frequency of severe hypoglycaemia and an improvement in quality of life scores, demonstrating its effectiveness in enhancing overall diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose adjustment for normal eating (DAFNE) - an audit of outcomes in Australia. McIntyre, HD., Knight, BA., Harvey, DM., et al.[2022]

A systematic review of 80 studies on diabetes education for children with type 1 diabetes found that most educational interventions did not significantly improve metabolic control (HbA1c levels) compared to standard care, indicating limited efficacy.

While some interventions showed positive effects on self-management and psychosocial outcomes, the overall evidence was inconsistent, and no specific educational approach was identified as superior for improving diabetes control or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes education for children with type 1 diabetes mellitus and their families. Couch, R., Jetha, M., Dryden, DM., et al.[2022]

A five-day structured education program for type 1 diabetes significantly reduced severe hypoglycaemic events from 24.7% to 12.1% and severe diabetes-related distress from 29.3% to 12.6% among 506 participants, indicating improved safety and quality of life.

Participants with the highest baseline HbA1c levels experienced a clinically significant reduction in HbA1c from 9.7% to 9.0%, demonstrating the efficacy of the education program in managing diabetes for those with the greatest clinical need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured type 1 diabetes education delivered in routine care in Australia reduces diabetes-related emergencies and severe diabetes-related distress: The OzDAFNE program. Speight, J., Holmes-Truscott, E., Harvey, DM., et al.[2022]

The SEREN 'Diabetes at Diagnosis' education module improved parent-reported effectiveness and user-friendliness of educational resources for children with type 1 diabetes, indicating a positive reception from families.

While there was no overall change in glycated hemoglobin (HbA1c) levels, subgroup analysis suggested a potential benefit for younger children (ages 5-7) with a trend towards lower HbA1c, while older children (ages 11-16) showed an increase, highlighting the need for tailored approaches in diabetes education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questionnaire-based service evaluation of the efficacy and usefulness of SEREN: a structured education programme for children and young people diagnosed with type 1 diabetes mellitus. D'Souza, RS., Ryan, M., Hawkes, E., et al.[2021]

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. 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.

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. diabetesjournals.org diabetesjournals.org/care/article/45/2/484/140905/2022-National-Standards-for-Diabetes-Self

2022 National Standards for Diabetes Self-Management ... Outcome data may be clinical, behavioral, patient-reported, and PGHD. Examples for each of these outcome types are provided in Table 1. Process ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05735340/type-1-diabetes-education-and-support-study?q=diabetes

Type 1 Diabetes Education and Support Study ... evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

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. reporter.nih.gov reporter.nih.gov/search/10EECF0E478CC1DE7598B8961CAA4A01A2FFCEB861BF/project-details/10827441

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