150 Participants Needed

E3 Diabetes Program for Type 2 Diabetes

(E3Diabetes Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the E3 Multidisciplinary Team and E3 Self-Guided Type 2 Diabetes Education treatment for Type 2 Diabetes?

Research shows that programs involving multidisciplinary teams and self-management education can help people with Type 2 diabetes better control their blood sugar levels and improve their quality of life. These approaches often involve healthcare professionals like nurses and dietitians working together to provide education and support.12345

Is the E3 Diabetes Program for Type 2 Diabetes safe for humans?

The available research on diabetes education programs, including multidisciplinary and self-management education, generally shows improvements in health outcomes without significant safety concerns. However, specific safety data for the E3 Diabetes Program itself is not detailed in the provided studies.16789

How does the E3 Diabetes Program treatment differ from other treatments for type 2 diabetes?

The E3 Diabetes Program is unique because it uses a multidisciplinary team approach combined with self-guided education to help patients manage type 2 diabetes. This approach emphasizes comprehensive lifestyle changes and education, involving various healthcare professionals to support patients in achieving better control of their condition and preventing complications.110111213

What is the purpose of this trial?

This study aims to decrease the racial gap in type 2 diabetes control in African American and Latinx patients in Rush University Medical Center clinics.

Eligibility Criteria

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

My last A1C level was 8.0 or higher, indicating my Type 2 Diabetes is uncontrolled.
Following with Rush primary care provider in eligible Rush primary care clinics
African American and/or Latinx
See 1 more

Exclusion Criteria

I have Type 1 Diabetes.
Patient is already participating in another remote diabetes monitoring program
Patient has already participated in the E3 hypertension program
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote glucose monitoring, medication titration, and dietary education for 6 months

6 months
Predominantly via tele-health

Follow-up

Participants are monitored for changes in glycemic control and other health outcomes

6 months

Long-term Follow-up

A1C levels are measured to check for persistence in improvement

12 months

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes Team-Based GroupExperimental Treatment1 Intervention
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.
Group II: Diabetes Self-Guided GroupActive Control1 Intervention
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

Trials
448
Recruited
247,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

In a 2-year study involving 49 patients with Type 2 diabetes, those receiving Group Care from trained nurses and a dietitian showed significantly better metabolic control, with lower HbA1c and insulin levels compared to those receiving individual care.
Patients in the Group Care model also reported a better quality of life and a more positive attitude towards their health, suggesting that this approach not only improves clinical outcomes but also enhances patient engagement and support.
A randomised controlled clinical trial of nurse-, dietitian- and pedagogist-led Group Care for the management of Type 2 diabetes.Trento, M., Basile, M., Borgo, E., 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.
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]

References

Impact of a multidisciplinary intensive education program on type 2 diabetes mellitus patients' glycemic control and cardiovascular risk factors. [2023]
A randomised controlled clinical trial of nurse-, dietitian- and pedagogist-led Group Care for the management of Type 2 diabetes. [2022]
Optimization of Care for Adult Outpatients With Type 2 Diabetes Through the Diabetes Self-Management Multidisciplinary Program: A Randomized Clinical Trial. [2022]
Group visits improve metabolic control in type 2 diabetes: a 2-year follow-up. [2022]
Diabetes Self-Management Education and Medical Nutrition Therapy: A Multisite Study Documenting the Efficacy of Registered Dietitian Nutritionist Interventions in the Management of Glycemic Control and Diabetic Dyslipidemia through Retrospective Chart Review. [2022]
Diabetes education and insulin therapy: when will they ever learn? [2019]
The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. [2023]
Effect of online diabetes training for hospitalists on inpatient glycaemia. [2013]
Diabetes self-management education (DSME) for older persons in Western countries: A scoping review. [2023]
Intensive diabetes education program and multidisciplinary team approach in management of newly diagnosed type 1 diabetes mellitus: a greater patient benefit, experience at Siriraj Hospital. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
The diabetes education team in the management of non-insulin-dependent diabetes mellitus. [2019]
[A diabetes care team--role of diabetes specialists and certified diabetes educator]. [2009]
Educational program for diabetic patients in Korea--multidisplinary intensive management. [2015]
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