E3 Diabetes Program for Type 2 Diabetes
(E3Diabetes Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve diabetes management among African American and Latinx communities by testing two different approaches. One group will receive support from a team of health professionals, including a pharmacist and dietitian, through remote check-ins to manage diabetes (E3 Multidisciplinary Team). The other group will receive educational materials and reminders about diabetes care (E3 Self-Guided Type 2 Diabetes Education). Individuals with uncontrolled Type 2 diabetes (high blood sugar levels) for three months who see a doctor at Rush University Medical Center might be a good fit. Participants must have a cellphone for remote communication.
As an unphased trial, this study offers a unique opportunity to contribute to diabetes care improvements in 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.
What prior data suggests that this program is safe for type 2 diabetes patients?
Research has shown that using a team of diverse healthcare professionals to manage type 2 diabetes is well-received by patients. These teams, often including pharmacists, social workers, and dietitians, have successfully helped patients better control their diabetes. For instance, one study found that 28% of patients with poorly controlled diabetes improved after joining such a program. No major negative effects were reported from this team-based care, indicating its safety for people with type 2 diabetes.
The self-guided education component of the trial includes educational materials and regular check-ups, which are standard in diabetes care. This approach is generally safe, as it equips patients with the knowledge and tools to manage their condition without introducing new medications or treatments.
Overall, both methods in this trial aim to improve diabetes care through education and support, rather than introducing new medical treatments, typically resulting in a safe experience for participants.12345Why are researchers excited about this trial?
Researchers are excited about the E3 Diabetes Program for Type 2 Diabetes because it introduces a new approach to managing the condition through a multidisciplinary team and self-guided education. Unlike standard care, which typically involves regular physician visits and medication adjustments, the Diabetes Team-Based Group leverages a team of health professionals, including a pharmacist, social worker, community health worker, and dietitian, to provide comprehensive support via tele-health. This team approach focuses not only on glucose monitoring and medication management but also on addressing social needs and dietary education, which could lead to more personalized and holistic care. Meanwhile, the Diabetes Self-Guided Group empowers patients by combining standard care with educational materials and regular reminders, potentially enhancing patient engagement and self-management skills. These innovative methods aim to improve outcomes by making diabetes management more accessible and tailored to individual needs.
What evidence suggests that this trial's treatments could be effective for type 2 diabetes?
This trial will compare two approaches for managing type 2 diabetes. Participants in the "Diabetes Team-Based Group" will receive care from a multidisciplinary team, including a pharmacist, social worker, community health worker, and dietician. Research has shown that teams of diverse healthcare specialists can effectively manage type 2 diabetes. One study found that 28% of patients with poorly controlled diabetes improved after joining such a program. Another study demonstrated that having specialists in care teams led to better blood sugar control. This method involves working closely with patients to monitor blood sugar levels, adjust medications, and provide dietary advice, which has been shown to lower HbA1c levels, indicating better long-term diabetes control.
Meanwhile, participants in the "Diabetes Self-Guided Group" will receive tools and information to manage their diabetes independently. Although there is less direct evidence about this specific method, self-management education is generally known to help control diabetes by equipping patients with the necessary knowledge and skills.13678Are You a Good Fit for This Trial?
This trial is for African American and Latinx adults with uncontrolled Type 2 Diabetes (A1C level of 8.0 or higher in the past 3 months), who are patients at eligible Rush primary care clinics, have access to a cellphone, and are not enrolled in other remote diabetes programs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive remote glucose monitoring, medication titration, and dietary education for 6 months
Follow-up
Participants are monitored for changes in glycemic control and other health outcomes
Long-term Follow-up
A1C levels are measured to check for persistence in improvement
What Are the Treatments Tested in This Trial?
Interventions
- E3 Multidisciplinary Team
- E3 Self-Guided Type 2 Diabetes Education
Trial Overview
The study tests two approaches: one where patients work with an E3 Multidisciplinary Team, and another where they use E3 Self-Guided Education to manage their Type 2 Diabetes. The goal is to improve diabetes control among these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
A multidisciplinary team composed of a pharmacist, social worker, community health worker, and dietician will provide glucose monitoring, medication titration, diet education and reinforcement, and referrals for social needs. The pharmacist will remind patients to get A1C readings at 3 months and 6 months. The team will interact with the patients predominantly via tele-health remotely for 6 months.
A registered nurse will ensure patients have glucose monitors and supplies on enrollment and will call to remind patients to obtain A1C readings at 3 months and 6 months. Patients will continue with standard clinical care for type 2 diabetes in addition to receiving timed, mailed educational materials on type 2 diabetes monitoring and diabetes diet and lifestyle recommendations for 6 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Published Research Related to This Trial
Citations
The multidisciplinary team in diagnosing and treatment of ...
Multidisciplinary Teams (MDTs) has been suggested as an intervention to overcome some of the complexities experienced by people with diabetes and comorbidities.
The involvement of specialists in primary healthcare teams for ...
This systematic review and meta-analysis aimed to assess the effectiveness of specialist involvement in primary healthcare teams on glycemic control of ...
Implementation and Outcomes of Multidisciplinary ...
In our study, 28% of poorly controlled patients responded positively to the program, leading to a decrease in the percentage of poorly ...
A randomized clinical trial of a collaborative home-based ...
The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review.
Efficiency of a multidisciplinary team care approach ...
Our results showed a successful achievement of the main endpoint which was a decrease of the HbA1c through a regular follow-up since the short hospitalization.
Multidisciplinary lifestyle treatment for type 2 diabetes in 12 ...
The aim of this study is to evaluate the applicability and cost-effectiveness of a multicomponent, multidisciplinary lifestyle program in 22 European regions.
7.
bmchealthservres.biomedcentral.com
bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11062-4Impact of a multi-disciplinary team-based care model for ...
The purpose of this paper is to describe the implementation of a TBC model for patients living with diabetes who receive care at a safety-net ...
8.
diabetesjournals.org
diabetesjournals.org/care/article/48/Supplement_1/S86/157563/5-Facilitating-Positive-Health-Behaviors-and-Well5. Facilitating Positive Health Behaviors and Well-being to ...
DSMES is associated with improved diabetes knowledge and self-care behaviors (16,17), lower A1C (16–21), lower self-reported weight (22), ...
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