Diabetes Education for Type 1 Diabetes

(T1DES Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Teaniese L Davis, PhD, MPH

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaiser Permanente

Disqualifiers: Cognitive impairment, Visual impairment, Diabetes complications

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.

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.

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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.

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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.

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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.

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.

Trial 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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Grady Health Systems Atlanta, GA

Kaiser Permanente Georgia Atlanta, GA

Who Is Running the Clinical Trial?

Kaiser Permanente Lead Sponsor

The Leona M. and Harry B. Helmsley Charitable Trust Collaborator

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

Emory University Collaborator

References

1. Denmark 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. [2019] Patient education is essential in management of type 1 diabetes (T1D).

2. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of education of the diabetic. Quality control in diabetes therapy]. [2007] Any successful treatment of type-I diabetic patients has to be based upon a detailed education of the diabetic patient in order to enable him to selfmanage his disease as much as possible. The goals of diabetes-therapy (i.e. near-normalization of glycaemia in order to prevent diabetic microangiopathy at as high a quality of life as possible) can only be achieved by actively involving the patient in his/her therapy. Thus patient education becomes the cornerstone of modern diabetes-care. The evaluation of diabetes-education has--eventually--be based upon an assessment of the quality of metabolic control. A number of studies have proven that effective diabetes-education programmes can substantially improve long-term metabolic control and the incidence of acute complications in type I diabetic patients. At present, it appears that the most efficient way to improve the overall quality of diabetes-care is to improve diabetes-education delivered to the patients.

3. 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] Structured education programmes for people with Type 1 diabetes can deliver improved diabetes control (including reduced severe hypoglycaemia) and quality of life. They can be cost-effective but are resource intensive. We tested the ability to deliver an evidence-based 5-day programme in diabetes centres too small to deliver the courses.

4. Denmark 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. [2018] Diabetes education of patients and/or parents is an essential part of diabetes care with effects on diabetes outcome. The objective of our study was to describe the current practice of diabetes education in Germany and Austria with regard to training frequency, patient age, migration background and diabetes therapy in a large cohort of pediatric patients with diabetes mellitus type 1 (T1DM).

5. Spain pubmed.ncbi.nlm.nih.gov

Impact of diabetes education on type 1 diabetes mellitus control in children. [2022] Diabetes education is an essential tool to achieve treatment objectives in type1 diabetes mellitus (T1DM). The aim of this study was to determine if understanding of diabetes by caregivers/patients or sociodemographic factors affect blood glucose control in children and adolescents with T1DM.

6. Denmark pubmed.ncbi.nlm.nih.gov

A structured 1-year education program for children with newly diagnosed type 1 diabetes improves early glycemic control. [2022] The diagnosis of type 1 diabetes (T1D) brings significant medical, psychosocial, and educational challenges for the child, family, and medical team. We developed a structured certified diabetes educator (CDE) led program spanning the year after diagnosis with the goal of supporting families as their understanding of this chronic disease and its management evolves.

7. England pubmed.ncbi.nlm.nih.gov

Glycaemic control and weight 7 years after Dose Adjustment For Normal Eating (DAFNE) structured education in Type 1 diabetes. [2022] The provision of structured education is increasingly prevalent in the management of Type 1 diabetes. There are little long-term follow-up data from such programmes. We have assessed HbA(1c) and weight over a 7-year period following the Dose Adjustment For Normal Eating (DAFNE) structured education course.

8. England pubmed.ncbi.nlm.nih.gov

Dietitians' perspectives on challenges and prospects for group-based education to adults with type 1 diabetes - a qualitative study. [2022] Type 1 diabetes (T1DM) is an autoimmune disorder which can have short- and long-term adverse effects on health. Dietitians in diabetes offer specialist evidence-based advice to people with T1DM and provide education in either individual or group settings. The purpose of this study was to explore dietitians' perception of, and role in, group-based education as well as prospects for development.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. [2021] Objective: One way of improving the prognosis for the growing numbers of people with type 1 diabetes (T1D) is to increase their frequency of exercise. One known barrier to this is the lack of cohesive support and information from care providers. To better understand the issues around existing support for patients wishing to exercise and inform the design of an education package specifically to facilitate safe exercise we interviewed care providers and patients about the existing provision of support. Research Design and Methods: The study was based within two large UK teaching hospitals where four focus groups were undertaken two consisting of patients diagnosed with T1D who undertook regular exercise, and two with health care providers (HCPs) that were part of the diabetes care team. In all 14 patients and 11 staff were involved. These were complemented by two 1:1 interviews with staff unable to attend group discussions. Results: We found the successful provision of education and advice was influenced by factors relating to the individual patient and their service provider. Patient factors included the type of activity and complexity of the exercise regime, the level of engagement with their condition and care and health literacy. Service-related factors included inconsistent training, a lack of capacity and continuity, and limited coherence of information from across their care team. Conclusions: Any education package developed to support exercise in patients with type 1 diabetes should be offered at a time following diagnosis in accordance with patients' preferences and priorities, contain information on how to manage regular and irregular bouts of exercise. Patients described how they related more closely to the stories of their peers than famous sports stars and one way this can be facilitated is by group delivery. The content and relevance of any supporting materials should be closely considered. Training in the delivery of a novel education package should be made available to staff across the care team to enable them to either deliver the course or increase their confidence in offering salient advice as part of routine care.

10. Denmark 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. [2022] Effective education is considered essential for people with type 1 diabetes mellitus (T1DM) to adhere to a complex and long-term medical regimen and to delay or prevent the onset of diabetes-related complications.