Diabetes Education for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Teaniese L Davis, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaiser Permanente

Disqualifiers: Developmental delay, Visual impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

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 data supports the idea that Diabetes Education for Type 1 Diabetes is an effective treatment?

The available research shows that Diabetes Education for Type 1 Diabetes is effective in several ways. For example, the OzDAFNE program in Australia has been shown to reduce diabetes-related emergencies and distress. Another study found that family-centered education improved how well patients stick to their treatment plans and manage their blood sugar levels. The SEREN program, designed for children, was also found to be useful and effective. Additionally, structured education programs can improve diabetes control and quality of life, as seen in the hub-and-spoke model study. The DAFNE program has demonstrated improvements in both health and emotional well-being for up to a year after the course. Overall, these studies suggest that structured education is a beneficial treatment for managing Type 1 Diabetes. ^{1 2 3 4 5}

What safety data exists for Diabetes Education for Type 1 Diabetes?

The provided research does not directly address safety data for the specific treatment 'Diabetes Education for Type 1 Diabetes' or its variations. However, it discusses the effectiveness and outcomes of structured education programs like KICk-OFF, SEREN, and DAFNE, which are similar in nature. These studies focus on biomedical and psychosocial outcomes, such as HbA1c levels, hypoglycemia rates, metabolic control, and quality of life, but do not explicitly mention safety data. ^{3 5 6 7 8}

Is the treatment T1DES a promising treatment for Type 1 Diabetes?

Yes, T1DES is a promising treatment for Type 1 Diabetes because education programs like it help people manage their condition better. They improve health outcomes and help people understand how to take care of themselves. ^{5 9 10 11 12}

Research Team

Teaniese L Davis, PhD

Principal Investigator

Kaiser Permanente Georgia

Eligibility Criteria

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

Self-reported race of Black or African American

Grady Health System Patient

Ability to read in English and provide informed consent

Exclusion Criteria

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

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

I do not have severe diabetes complications.

Trial Timeline

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)

Treatment Details

Interventions

• Diabetes Education (Behavioral Intervention)
• T1DES (Behavioral Intervention)

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.

Participant Groups

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+

Greg A. Adams

Kaiser Permanente

Chief Executive Officer since 2019

MBA from University of Southern California

Dr. Edward M. Ellison

Kaiser Permanente

Chief Medical Officer since 2015

MD from Harvard Medical School

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Sarah E. Paul

The Leona M. and Harry B. Helmsley Charitable Trust

Chief Executive Officer since 2021

Harvard summa cum laude, J.D. from Harvard Law School

Walter Panzirer

The Leona M. and Harry B. Helmsley Charitable Trust

Chief Medical Officer since 2021

MD

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

Grady Memorial Hospital

Collaborator

Trials

5

Recruited

8,500+

Findings from Research

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]

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 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 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]

References

1. Ireland 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. [2022]

2. United States 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. [2023]

3. England 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. [2022]

5. England 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. [2023]

6. England 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. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Dose adjustment for normal eating (DAFNE) - an audit of outcomes in Australia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Diabetes education for children with type 1 diabetes mellitus and their families. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Impact of diabetes education on type 1 diabetes mellitus control in children. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Initial versus ongoing education: Perspectives of people with type 1 diabetes in 13 countries. [2018]

11. Ireland pubmed.ncbi.nlm.nih.gov

Understanding information and education gaps among people with type 1 diabetes: a qualitative investigation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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