Together Overcoming Diabetes for Diabetes

Overseen By Courtney Claussen, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Pregnant, Nursing, Dialysis, Cushing's, others

Compensation: Varies

Number of Visits: 2

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.

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 healthcare provider.

Is the treatment in the TOD Great Plains trial generally safe for humans?

The safety of treatments similar to those in the TOD Great Plains trial, like glucagon-like peptide-1 (GLP-1) agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors, has been studied. These treatments have been associated with some adverse drug reactions (side effects), but understanding and managing these reactions is important for safe use. ^{1 2 3 4 5}

What makes the TOD Great Plains treatment unique for diabetes management?

The TOD Great Plains treatment is unique because it involves a home-visiting program specifically designed for Native youth, focusing on improving diet quality and potentially enhancing blood pressure and glycemic control, which is not a common approach in standard diabetes treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment TOD Great Plains for diabetes?

The effectiveness of the treatment TOD Great Plains for diabetes may be supported by studies showing that structured education programs for diabetes, like the Diabetes Teaching and Treatment Program (DTTP), can improve blood sugar control (HbA1c levels) and patient knowledge, which are important for managing diabetes effectively. ^{11 12 13 14 15}

Who Is on the Research Team?

Donald Warne, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for American Indian/Alaska Native individuals who have diabetes. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be willing to follow the study procedures.

Inclusion Criteria

Adult Index Participants: Self-identifies as American Indian or Alaska Native

Adult Index Participants: Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center

I am between 10 and 25 years old.

Exclusion Criteria

I am able to fully participate without any planned interruptions.

I am willing to be a support person for another adult in the study.

Adult Index Participants: Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Together Overcoming Diabetes (TOD) intervention tailored for Lakota caregivers

6 months

Visits at baseline, 2 months, 4 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TOD Great Plains

Trial Overview The study tests a tailored diabetes intervention called Together Overcoming Diabetes (TOD) against a waitlist standard of care in AI/AN populations. The effectiveness of TOD in managing diabetes will be compared with those receiving usual care.

How Is the Trial Designed?

Group I: Together Overcoming Diabetes Intervention Experimental Treatment 1 Intervention

Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families

Group II: Waitlist Standard of Care Placebo Group 1 Intervention

Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

The NIH Community Engagement Alliance

Collaborator

Trials

1

Recruited

80+

Oyate Health Center

Collaborator

Trials

1

Recruited

80+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study analyzing FDA Adverse Event Reporting System data from January 2013 to March 2022 found that different DPP-4 inhibitors have varying risks for serious side effects, such as acute kidney injury and pemphigoid, which can guide treatment choices for diabetes patients.

Specifically, alogliptin showed a significantly lower risk of acute kidney injury compared to sitagliptin, but a higher risk of pemphigoid, highlighting the importance of selecting the appropriate DPP-4 inhibitor based on a patient's specific health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. Ogura, T., Shiraishi, C.[2023]

A systematic review of 68 observational studies on non-serious adverse drug events (ADEs) in type 2 diabetes revealed that many studies used inadequate methods for detecting ADEs, with only a third exceeding regulatory requirements for sample size and follow-up duration.

The most effective method for identifying a diverse range of ADEs was solicited surveillance by healthcare professionals, while patient surveys primarily focused on specific issues like hypoglycemia, indicating a need for better methodologies and a combination of approaches to fully capture ADEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. Hakobyan, L., Haaijer-Ruskamp, FM., de Zeeuw, D., et al.[2022]

The Gestational Diabetes Group Program (GDGP) effectively improved diabetes self-management education for pregnant women, leading to significant increases in knowledge and empowerment regarding their condition.

Participants in the GDGP reported high satisfaction levels and experienced optimal pregnancy outcomes, demonstrating the program's efficacy in supporting underserved populations through an interdisciplinary care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gestational Diabetes Group Program. Nasso, J., McCloskey, C., Nordquist, S., et al.[2020]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Long-term evaluation of a structured outpatient education programme for intensified insulin therapy in patients with Type 1 diabetes: a 12-year follow-up. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a structured outpatient group education program for intensive insulin therapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improvement of Statin Utilization in Veterans With Diabetes Through Pharmacy Interventions. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Diabetes rehabilitation: development and first results of a Multidisciplinary Intensive Education Program for patients with prolonged self-management difficulties. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Substantial improvement in HbA1c following a treatment and teaching programme for people with type 2 diabetes on conventional insulin therapy in an in- and outpatient setting. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Insight in the safety profile of antidiabetic agents glucagon-like peptide-1 agonists and dipeptidyl peptidase-4 inhibitors in daily practice from the patient perspective. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. [2023]

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

Is a modified Global Trigger Tool method using automatic trigger identification valid when measuring adverse events? [2020]

9. England pubmed.ncbi.nlm.nih.gov

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse drug events in Chinese elder inpatients: a retrospective review for evaluating the efficiency of the Global Trigger Tool. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Native Youth Participating in the Together on Diabetes 12-Month Home-Visiting Program Reported Improvements in Alternative Healthy Eating Index-2010 Diet Quality Domains Likely to Be Associated With Blood Pressure and Glycemic Control. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The Gestational Diabetes Group Program. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Empowerment for diabetes management: integrating true self-management into the medical treatment and management of diabetes mellitus. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Reducing the burden of diabetes. The National Diabetes Education Program. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Engaging faith-based resources to initiate and support diabetes self-management among African Americans: a collaboration of informal and formal systems of care. [2022]