Integrated Diabetes Care for Type 2 Diabetes

Overseen By Hanaa Sallam, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Pregnancy, Type 1 diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with type 2 diabetes better manage their condition. Participants will be divided into two groups: one will continue with their regular care (Standard of Care), while the other will join a year-long program called iDSMES. This program includes education on diabetes management, nutrition, and exercise, along with counseling on mental, financial, and social needs. Suitable candidates should have type 2 diabetes, a BMI (body mass index) of 25 or higher (23 or higher if Asian), and an A1c (a measure of blood sugar control) of at least 7%. As an unphased trial, this study provides a unique opportunity to explore comprehensive diabetes management strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that certain medications might be considered exclusionary by the study investigators, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this integrated model is safe for diabetes care?

Research has shown that education and support programs for diabetes, such as iDSMES, are generally safe. These programs teach individuals how to manage their diabetes better, offering guidance on diet, exercise, and proper medication use. Studies have found that working with a diabetes educator can improve health outcomes without major safety concerns.

Some sources suggest that these programs can lower the risk of diabetes-related complications and help reduce the cost of diabetes care. No evidence of serious side effects has been found from participating in these educational programs, indicating that iDSMES is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Diabetes Self-Management, Education, and Support (iDSMES) program because it offers a comprehensive, personalized approach to managing Type 2 Diabetes. Unlike the standard treatment, which typically focuses on medication and routine check-ups, iDSMES emphasizes intensive education and lifestyle coaching, delivered either virtually or in-person. This program also addresses social determinants of health, aiming to provide a more holistic and supportive experience for participants. By integrating these elements, iDSMES has the potential to improve not only glycemic control but also overall health outcomes and patient satisfaction.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that Diabetes Self-Management Education and Support (DSMES) programs help people with diabetes better control blood sugar levels, cholesterol, and body weight. These programs can also slightly improve blood pressure. One study found that DSMES programs are more effective than standard care for managing diabetes. Another study showed that these programs can lower A1c levels, an important measure of long-term blood sugar control. The success of DSMES links to the time spent with diabetes educators, who assist patients in managing their condition. In this trial, participants will be randomized to receive either the integrated model (iDSMES) or Standard of Care. These findings suggest that the integrated model (iDSMES) could improve health outcomes for people with type 2 diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 13-84 with type 2 diabetes, who have a Hemoglobin A1c value of at least 7% and a BMI of at least 25 (or 23 for Asians). It's not suitable for those unable to commit to a year-long study, planning to move away from the area, pregnant women, prisoners, or anyone with conditions that could affect their survival.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

My BMI is 25 or higher (23 if I'm Asian).

Your hemoglobin A1c level is 7% or higher.

Exclusion Criteria

I am younger than 13 or older than 84.

Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.

My health conditions or medications do not disqualify me from the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants in the intervention arm are assessed for social and physical needs before enrollment

1-2 weeks

Treatment

Participants receive a year-long education program (iDSMES) including dietary counseling, physical and occupational therapy, and other support services

52 weeks

Regular sessions (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iDSMES
• Standard of Care

Trial Overview The study compares standard diabetes care against an integrated model called iDSMES. Participants in the iDSMES group will receive comprehensive support including dietary counseling and various therapies aimed at improving self-management of diabetes over one year.

How Is the Trial Designed?

Group I: iDSMES Active Control 1 Intervention

Eligible study subjects randomized to the intervention arm will receive: A. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.

Group II: Standard of Care Placebo Group 1 Intervention

Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Citations

1. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1543298/full

Comparative effectiveness of diabetes self-management ... This RCT highlights the universal benefits of self-paced virtual diabetes self-management interventions to reduce A1c among Texans with unmanaged T2DM.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4833481/

Diabetes Self-management Education and Support in Type ... In addition, better outcomes have been shown to be associated with the amount of time spent with a diabetes educator (3,4,7,11). This position statement arms ...

3. diabetesjournals.org diabetesjournals.org/care/article/45/2/484/140905/2022-National-Standards-for-Diabetes-Self

2022 National Standards for Diabetes Self-Management ... By measuring and monitoring both process and outcome data on an ongoing basis, the DSMES team can identify areas for improvement. They can then ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S277306542500104X

Effectiveness of Diabetes Self-Management Education and ... This study evaluates the effectiveness of DSMES interventions compared to standard diabetes care in Africa, with a focus on glycemic control and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6968799/

Effectiveness of Diabetes Self-Management Educational ... DSME programs are highly effective in improving glycemic control, lipid profile and BMI, and modestly effective in improving BP.

6. academic.oup.com academic.oup.com/jcem/article/110/Supplement_2/S91/8042177

Role of Diabetes Self-management Education for Our Health ... Educating people with diabetes improves outcomes and affects the economic burden on the individual and health systems.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858717302395

Diabetes structured self-management education programmes In this review, we examine the effectiveness of diabetes self-management education on biomedical, behavioural, and psychosocial outcomes among adults with type ...

8. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16257

Association between diabetes self‐management education ... DSME workshops for an elderly Argentinian type 2 cohort resulted in an 33% lower 6-year crude mortality rate, but significance was lost in ...