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?

Diabetic ketoacidosis (DKA) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (T1DM) \<50 years old. This suggests the need to develop interventions to reduce DKA events. Innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce DKA. Designating a family member, friend, or caregiver as a Follower was associated with reduction in HbA1C, increased time in range, and improvement in quality of life metrics in people with T1DM. However, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with T1DM (prior prospective studies involved either pregnant women with T1DM or adults ≥60 years of age with T1DM). 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 to reduce severe hyperglycemia, a modifiable risk factor for DKA, in adults with T1DM at high risk for DKA. The intervention uses real-time glucose data sharing with a Follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with T1DM and their chosen Follower). The overall hypothesis is that the FAM intervention will improve glycemia with the primary outcome studied in this preliminary pilot study being percentage of time spent with glucose ≥250 mg/dL.

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.

How is the FAM Intervention treatment for Type 1 Diabetes different from other treatments?

The FAM Intervention is unique because it combines family involvement, action planning, and remote monitoring to help manage Type 1 Diabetes, focusing on behavioral and motivational support rather than just medical treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the FAM Intervention treatment for Type 1 Diabetes?

Research shows that behavioral interventions integrated into clinics can help families manage Type 1 Diabetes better, and motivational interventions can improve adherence in adolescents. Additionally, remote monitoring technology has been positively received by parents managing young children's diabetes, suggesting these components of the FAM Intervention may be effective. ^{1 2 6 7 8}

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

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 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]

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 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 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]

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]

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]

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]

Citations

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

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]

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

A multicomponent motivational intervention to improve adherence among adolescents with poorly controlled type 1 diabetes: a pilot study. [2022]

3. England 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. [2022]

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

The Feasibility of a Pilot Intervention for Parents of Young Children Newly Diagnosed with Type 1 Diabetes. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness. [2023]

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

Randomized trial of a diabetes self-management education and family teamwork intervention in adolescents with Type 1 diabetes. [2022]

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

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

8. England 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. [2022]