Integrated Diabetes Care for Type 2 Diabetes
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Assessment
Participants in the intervention arm are assessed for social and physical needs before enrollment
Treatment
Participants receive a year-long education program (iDSMES) including dietary counseling, physical and occupational therapy, and other support services
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Active Control
Placebo Group
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.
Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Citations
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.
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-Self2022 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 ...
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 ...
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.
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.
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 ...
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 ...
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