Family-Focused Diabetes Management for Type 2 Diabetes

Overseen By Sandra Solove, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Terminal condition, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage type 2 diabetes by emphasizing family support. It aims to determine if involving a family member can enhance blood sugar control and overall quality of life for African American adults with type 2 diabetes. Participants will either continue their usual care or join virtual group sessions with a family member, learning about diabetes management and support through the Family Dyad Diabetes Intervention. This trial suits African American adults who have had type 2 diabetes for at least six months and have a family member willing to participate. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to explore this innovative approach.

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 doctor.

Is there any evidence suggesting that the family dyad diabetes intervention is likely to be safe?

Research has shown that involving family in diabetes self-care education can improve habits like checking blood sugar and visiting the doctor. However, little information exists on the safety of the specific family-focused diabetes program being tested. This trial is in its early stages, so details about possible side effects or participant responses are limited. Early trial phases typically assess the treatment's safety and participant comfort. So far, no specific evidence of harm from this program has emerged, but further research is needed to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the family dyad diabetes intervention for type 2 diabetes because it focuses on something many current treatments overlook: family involvement. While standard treatments often emphasize medication and lifestyle changes like diet and exercise, this approach highlights the role of family support in managing diabetes. By offering virtual group sessions and personalized feedback calls, it provides a unique combination of education and family-focused support, which could improve self-management and overall health outcomes for patients. This method leverages the power of family dynamics, aiming to create a supportive environment that encourages better adherence to diabetes management practices.

What evidence suggests that the family dyad diabetes intervention could be effective for type 2 diabetes?

Research shows that involving family can help manage type 2 diabetes. In this trial, participants in the family dyad intervention arm will receive a program with group sessions focused on diabetes self-management and family support. Previous studies with similar programs have shown that patients and their families manage diabetes better and eat healthier. These programs typically include group sessions that teach diabetes care and encourage family support. Participants often feel more confident in managing their condition and report making healthier lifestyle choices. Early findings suggest that family involvement can help patients maintain better blood sugar control. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

African American adults over 40 with type 2 diabetes and a family member (spouse, adult child, or sibling) who live together can join. Both must speak English and be able to walk. The patient needs an A1c > 7.5% and diagnosed for at least six months. Those with cognitive impairments, advanced conditions, or unclear diabetes diagnosis are excluded.

Inclusion Criteria

You are African American and have type 2 diabetes.

Family members being a spouse, adult child, or sibling

I have type 2 diabetes and can walk.

Exclusion Criteria

I have type 2 diabetes but no definitive proof of it.

You have type 2 diabetes and your family members cannot make decisions for you.

You have type 2 diabetes and a family member who is pregnant or has a serious illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 virtual group sessions on diabetes self-management and family support over 12 weeks

12 weeks

10 virtual sessions

Post-intervention Assessment

Participants are assessed immediately after the intervention for changes in health-related quality of life and diabetes control

1 week

Follow-up

Participants are monitored for changes in diabetes control and blood pressure six months after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Family dyad diabetes intervention

Trial Overview The trial is testing how well a program designed for African American adults with type 2 diabetes and their family members works in improving blood sugar control and quality of life. It's a randomized controlled study comparing the new intervention against usual care.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Patient-family member dyads in the family dyad intervention arm will receive 1) 10 sessions (8 weekly and 2 biweekly) over 12 weeks of family-dyad-focused, virtual group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.

Group II: Control Active Control 1 Intervention

All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Group-based diabetes self-management education (DSME) significantly reduces HbA1c levels in type 2 diabetes patients, with reductions observed at 6 months (0.44%), 12 months (0.46%), and 2 years (0.87%), indicating effective long-term management of blood sugar levels.

Participants in group-based DSME also showed significant improvements in diabetes knowledge and self-management skills, with effect sizes indicating strong benefits at 6 months and beyond, highlighting the educational advantages of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. Steinsbekk, A., Rygg, LØ., Lisulo, M., et al.[2022]

A study involving 211 Marshallese adults with type 2 diabetes found that a Family Diabetes Self-Management Education (DSME) intervention led to greater improvements in glucose monitoring and doctor visits compared to a Standard DSME intervention.

Participants in the Family DSME group showed a more significant increase in glucose monitoring engagement over 12 months, suggesting that family involvement in diabetes education can enhance self-care behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Family Diabetes Self-management Education on Self-care Behaviors of Marshallese Adults with Type 2 Diabetes. Felix, HC., Narcisse, MR., Long, CR., et al.[2020]

Participation in a 6-week Diabetes Self-Management Education (DSME) program led to a significant reduction in hemoglobin A1c (HgbA1c) levels by 1.6% in overweight/obese patients, indicating improved glycemic control.

While BMI did not change significantly, participants showed marked improvements in diabetes knowledge and confidence, suggesting that DSME enhances self-management skills in community health center patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Diabetes Self-Management Education in Community Health. Brown, K., Lee, LT., Selleck, C.[2020]

In a study involving Marshallese adults with Type 2 diabetes, family members who attended diabetes self-management education (DSME) sessions did not show significant improvements in A1c levels, BMI, food consumption, or physical activity compared to those who did not attend, indicating low engagement and effectiveness of the program for families.

The only significant predictor of having a normal A1c level after 12 months was a reduction in BMI, suggesting that while family DSME may not have directly benefited family members, weight management could be crucial for diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a family diabetes self-management education intervention on the patients' supporters. Felix, HC., Narcisse, MR., Long, CR., et al.[2023]

The study aims to compare the effectiveness of Family-DSMES, which involves family members in diabetes self-management education, against Standard-DSMES for individuals with type 2 diabetes, involving participants aged 18 and older with a hemoglobin A1c of 7.0% or higher.

Data will be collected at multiple time points (baseline, post-intervention, and at 6, 12, and 18 months) to assess various outcomes, including the primary outcome of hemoglobin A1c levels, and to evaluate the impact on both the person with diabetes and their family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Mayberry, LS., Felix, HC., Hudson, J., et al.[2023]

The study identified five key attributes of effective diabetes self-management education (DSME) interventions for individuals with type 2 diabetes, categorized into skills-related (decision making, problem solving, taking action) and information-related attributes (patient-provider interaction, resource utilization).

By clarifying these attributes, the research provides a measurable framework for designing and implementing DSME interventions, which can enhance the effectiveness of diabetes management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis. Othman, MM., Khudadad, H., Dughmosh, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40706841/

Family dyad-focused diabetes self-management intervention ... Family dyad-focused diabetes self-management intervention (FDSMI) for African American adults with type 2 diabetes: Study protocol · Authors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512727/

Family dyad-focused diabetes self-management ... We propose a small phase I/II randomized controlled trial (RCT) using virtual group sessions to examine: (1) the feasibility, acceptability and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05905575

NCT05905575 | A Family Dyad-focused Diabetes Self ... A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798389

Health Coaching for Patient-Family Dyads to Improve ... In this randomized clinical trial with 239 patient-supporter dyads, CO-IMPACT improved patient activation, diabetes self-efficacy, and healthy eating.

5. researchgate.net researchgate.net/publication/393907455_Family_dyad-focused_diabetes_self-management_intervention_FDSMI_for_African_American_adults_with_type_2_diabetes_Study_protocol

(PDF) Family dyad-focused diabetes self-management ... Family dyad-focused diabetes self-management intervention (FDSMI) for African American adults with type 2 diabetes: Study protocol. July 2025 ...

6. withpower.com withpower.com/trial/phase-diabetes-mellitus-5-2023-1981b

Family-Focused Diabetes Management for Type 2 Diabetes Research shows that involving family in diabetes self-management education (DSME) can improve self-care behaviors, like glucose monitoring and doctor visits, ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06764-1

Comparing the effectiveness of Family Support for Health ... This parallel arm randomized trial is designed to determine the effectiveness of Family Support for Health Action (FAM-ACT), a novel community ...