40 Participants Needed

Diabetes Education for Type 1 Diabetes

(T1DES Trial)

Recruiting at 1 trial location
TL
Overseen ByTeaniese L Davis, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

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 data supports the effectiveness of the treatment Diabetes Education for Type 1 Diabetes?

Research shows that diabetes education helps people with Type 1 diabetes better manage their condition, leading to improved blood sugar control and fewer complications. Studies indicate that structured education programs can enhance quality of life and are essential for effective diabetes care.12345

Is diabetes education safe for people with type 1 diabetes?

The research articles reviewed do not report any safety concerns related to diabetes education for people with type 1 diabetes, suggesting it is generally safe.56789

How is the Diabetes Education treatment for Type 1 Diabetes different from other treatments?

The Diabetes Education treatment for Type 1 Diabetes is unique because it focuses on providing structured education and support to help patients and their families understand and manage the condition effectively, rather than relying solely on medication. This approach emphasizes the importance of knowledge and lifestyle adjustments, such as diet and exercise, to improve blood sugar control and prevent complications.568910

Research Team

TL

Teaniese L Davis, PhD, MPH

Principal Investigator

Principal Investigator

Eligibility Criteria

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.
See 3 more

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: T1DESExperimental Treatment1 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 EducationActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Effect of patient education through a social network in young patients with type 1 diabetes in a Sub-Saharan context. [2019]
[Evaluation of education of the diabetic. Quality control in diabetes therapy]. [2007]
Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. [2022]
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. [2018]
Impact of diabetes education on type 1 diabetes mellitus control in children. [2022]
A structured 1-year education program for children with newly diagnosed type 1 diabetes improves early glycemic control. [2022]
Glycaemic control and weight 7 years after Dose Adjustment For Normal Eating (DAFNE) structured education in Type 1 diabetes. [2022]
Dietitians' perspectives on challenges and prospects for group-based education to adults with type 1 diabetes - a qualitative study. [2022]
Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. [2021]
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. [2022]
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