FAM Intervention for Type 1 Diabetes

Overseen By Jacob Kohlenberg, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must not be taking: SGLT2 inhibitors

Disqualifiers: Active malignancy, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help adults with Type 1 Diabetes manage their blood sugar levels more effectively. It tests whether monitoring and support from a family member, friend, or caregiver using real-time glucose data can reduce episodes of very high blood sugar, thereby lowering the risk of diabetic ketoacidosis, a serious diabetes complication. Participants should have had Type 1 Diabetes for at least a year, experience high blood sugar levels, and use a continuous glucose monitor that allows data sharing. The trial compares an intervention group using this support system, known as the FAM Intervention (Follower, Action Plan, and Remote Monitoring Intervention), against a control group. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively being treated with a sodium-glucose cotransporter-2 inhibitor or plan to start one in the next 6 months.

What prior data suggests that the FAM Intervention is safe for adults with Type 1 Diabetes?

In a previous study, continuous glucose monitoring (CGM) with real-time data sharing helped individuals feel more confident in managing their blood sugar levels. This approach reduced the time spent with high blood sugar, which is crucial for people with type 1 diabetes.

The FAM intervention builds on this by involving a family member or friend as a "Follower" to help track and manage blood sugar data. This method has shown promise in improving diabetes control without any serious side effects reported. However, as this is an early trial, safety data remains limited.

Since this trial is just beginning, researchers are still evaluating the treatment's safety. Early trials like this primarily focus on human safety. So far, data-sharing strategies with a follower have been well-tolerated. However, more research is needed to fully confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Type 1 Diabetes, which mainly involve insulin therapy and continuous glucose monitoring (CGM), the FAM Intervention is all about family-centered support and education. Researchers are excited about this approach because it combines technology with personal interaction, aiming to improve diabetes management through shared family experiences and better communication. This intervention recognizes the crucial role family plays in managing a chronic condition, potentially leading to more consistent glucose control and improved quality of life for patients.

What evidence suggests that the FAM Intervention is effective for reducing severe hyperglycemia in adults with Type 1 Diabetes?

This trial will evaluate the FAM Intervention, where a family member or friend helps monitor glucose levels, to determine its impact on managing type 1 diabetes. Research has shown that this method can lower HbA1C levels, indicating better blood sugar control, and increase the time blood sugar remains in a healthy range. These studies also noted improvements in the quality of life for those with type 1 diabetes. Sharing real-time glucose data and receiving personalized advice helps individuals make better decisions about their diabetes care. This approach can reduce the risk of very high blood sugar, a major factor in diabetic ketoacidosis, a serious diabetes complication. ^{1 2 3 4 6}

Who Is on the Research Team?

Jacob Kohlenberg, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults aged 18-65 with Type 1 Diabetes Mellitus (T1DM), having an HbA1C level between 8.0% and 14.0%, who use a continuous glucose monitor (CGM) that can share data in real-time are eligible for this trial. They must also have a Follower willing to participate, and both should be able to communicate in English without cognitive impairments.

Inclusion Criteria

I have a friend or family member over 18, without cognitive issues, willing to join the study with me.

HbA1C ≥8.0% - 14.0%

Both my partner and I can speak and understand English well.

Exclusion Criteria

Prisoner

I am not enrolled in hospice care.

Skin conditions that inhibit wearing a CGM sensor and known severe allergy to adhesives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FAM intervention, which includes a Follower, Action Plan, and Remote Monitoring of glucose data to reduce severe hyperglycemia

12 weeks

Regular remote monitoring and education sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FAM Intervention

Trial Overview The study is testing the 'FAM intervention' which includes sharing glucose data with a designated Follower, creating an Action Plan, and Remote Monitoring of glucose levels to prevent severe hyperglycemia compared to standard diabetes care alone.

How Is the Trial Designed?

Group I: intervention group Experimental Treatment 1 Intervention

anticipate 8 CGM and 2 non-CGM user dyads in the intervention group

Group II: control group Active Control 1 Intervention

anticipate 8 CGM and 2 non-CGM user dyads in the control group

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Educational interventions for children with type 1 diabetes effectively improve diabetes knowledge but do not consistently lead to better metabolic control, based on a review of 41 studies published between 1980 and 1999.

Psychosocial interventions, particularly coping skills training and peer support, are beneficial for adolescents in improving their adjustment to diabetes and can sometimes enhance metabolic control, while family interventions help reduce conflicts between parents and children regarding diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for children with diabetes and their families. Grey, M.[2019]

Parents of young children with type 1 diabetes reported that remote monitoring technology significantly improved their ability to manage their child's glucose levels, allowing them to engage in non-diabetes-related activities while still overseeing their child's care.

The use of a hybrid closed-loop insulin delivery system increased parents' confidence in allowing others to care for their children, enabling kids to enjoy activities like sleepovers and parties without constant parental supervision, although some parents expressed a need for breaks from caregiving responsibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study. Hart, RI., Kimbell, B., Rankin, D., et al.[2022]

A family-centred group education program for adolescents with Type 1 diabetes did not lead to significant improvements in HbA1c levels compared to conventional care, indicating that the intervention may not be effective in this setting.

Attendance at the education sessions was low, with nearly one-third of families not attending any sessions, suggesting that more personalized and engaging educational approaches may be necessary to better support families managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type 1 diabetes. Murphy, HR., Wadham, C., Hassler-Hurst, J., et al.[2022]

A pilot study involving 17 adolescents with poorly controlled type 1 diabetes showed significant improvements in blood glucose monitoring frequency and glycemic control after a 14-week motivational intervention that included family-based contingency management.

The adolescents' HbA1c levels improved significantly, indicating better diabetes management, which suggests that this multicomponent approach could be effective and warrants further testing in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent motivational intervention to improve adherence among adolescents with poorly controlled type 1 diabetes: a pilot study. Stanger, C., Ryan, SR., Delhey, LM., et al.[2022]

A self-management intervention for children and young people with Type 1 diabetes was developed through collaboration with families, focusing on key topics like blood glucose control and self-management techniques, and was well-received by participants.

Despite the positive feedback and enthusiasm from families, the pilot study did not provide sufficient evidence to support a larger randomized control trial aimed at improving HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an acceptable and feasible self-management group for children, young people and families living with Type 1 diabetes. Cai, RA., Holt, RIG., Casdagli, L., et al.[2022]

A pilot study involving 30 mothers of young children with type 1 diabetes showed that a phone-based intervention was feasible and well-accepted, with over 80% of participants completing the program and reporting high satisfaction.

The intervention group experienced significant improvements in social support and quality of life over time, and there was a trend suggesting it may help mitigate the impact of maternal depressive symptoms on the child's glycemic control (HbA1c).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of a Pilot Intervention for Parents of Young Children Newly Diagnosed with Type 1 Diabetes. Mackey, ER., Herbert, L., Monaghan, M., et al.[2020]

A 2-year randomized clinical trial involving 390 families showed that a low-intensity, clinic-integrated behavioral intervention significantly improved glycemic control in youth with type 1 diabetes, particularly in those aged 12 to 14.

The intervention effectively prevented the typical decline in diabetes management during adolescence, suggesting it could be a valuable approach to integrate behavioral support into medical care for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Nansel, TR., Iannotti, RJ., Liu, A.[2022]

A trial involving 308 children with type 1 diabetes found that standardized self-management kits did not improve glycemic control, as evidenced by no significant change in HbA1c levels after 6 months, with only 18% of participants achieving recommended levels.

While the kits initially reduced worry about diabetes management at 3 months, they ultimately led to increased worry and decreased treatment adherence by 6 months, suggesting that the kits may have hindered effective self-management rather than helping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness. Noyes, J., Allen, D., Carter, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06114186

Study Details | NCT06114186 | FAM (Follower, Action Plan, ... This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data ...

2. studyfinder.umn.edu studyfinder.umn.edu/studies/30523

FAM (Follower, Action Plan, and Remote Monitoring) ... Participants will receive a personalized Diabetes Action Plan to help navigate the challenges of living with diabetes. The “Follower” (family member, friend, or ...

3. withpower.com withpower.com/trial/early-phase-1-diabetes-mellitus-10-2023-05709

FAM Intervention for Type 1 Diabetes This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data ...

4. ctv.veeva.com ctv.veeva.com/study/fam-follower-action-plan-and-remote-monitoring-intervention-to-reduce-severe-hyperglycemia-in-ad

FAM (Follower, Action Plan, and Remote Monitoring ... This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4624026/

Family interventions to improve diabetes outcomes for adults We found evidence for improvement in patients' self-efficacy, perceived social support, diabetes knowledge, and diabetes self-care across the studies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8968547/

Continuous Glucose Monitoring Data Sharing in Older ... This study aimed to address the barriers to sharing CGM data. Our objective was to examine the feasibility of using CGM with the Follow app and a data-sharing ...