FAMS-T1D + Digital Resources for Type 1 Diabetes

Recruiting at 1 trial location

Overseen By Erin M Bergner, PhD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Insulin

Disqualifiers: Intellectual disability, Blindness, Severe mental illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

140 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves people with Type 1 Diabetes who are already using insulin and continuous glucose monitors, it seems likely that you will continue your current diabetes management.

What data supports the effectiveness of the treatment Digital resources for diabetes, FAMS-T1D?

Research suggests that digital tools can help people with type 1 diabetes manage their condition better by supporting self-management and making it easier to track blood sugar levels. However, more studies are needed to fully understand their impact on improving diabetes care. ^{1 2 3 4 5}

What makes the FAMS-T1D treatment unique for type 1 diabetes?

FAMS-T1D is unique because it combines traditional diabetes management with digital resources, potentially enhancing self-management and education through technology, which is not a standard approach in existing treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.

Eligibility Criteria

This trial is for young adults aged 18-24 with Type 1 Diabetes who have been on insulin for at least a year and either have high A1c levels or experience diabetes distress. They must use a CGM, be comfortable with texting, and speak English (or Spanish for support persons). Support persons must be over 18. Those with conditions like severe mental illness or plans to live abroad during the study cannot join.

Inclusion Criteria

I have Type 1 Diabetes and have been on insulin for over a year.

I can speak, read, and write in English or Spanish.

Can speak, read, and write in English

Exclusion Criteria

I have diabetes but no severe mental illness, blindness, or hearing problems that would stop me from completing the study.

Support persons planning to live outside of the country during the study period

You have diabetes and plan to live in another country during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FAMS-T1D intervention, including monthly phone coaching and text message support for 6 months

6 months

Monthly phone coaching sessions

Follow-up

Participants are monitored for changes in CGM use and satisfaction with data-sharing relationships

6 months

Treatment Details

Interventions

• Digital resources for diabetes
• FAMS-T1D

Trial Overview The trial is testing an adapted FAMS intervention designed to improve the use of Continuous Glucose Monitors (CGMs) in young adults with Type 1 Diabetes. It's part of a larger study where participants are given digital resources to help manage their condition.

Participant Groups

Group I: FAMS-T1D Experimental Treatment 2 Interventions

Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

Group II: Digital resources for diabetes Placebo Group 1 Intervention

All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of California, Merced

Collaborator

Trials

18

Recruited

6,100+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Findings from Research

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

In a study of 92 youth with type 1 diabetes using the Minimed 670G hybrid closed loop (HCL) system, 30% discontinued use within 6 months, with higher baseline HbA1c levels significantly predicting discontinuation.

The main barriers to continued use of HCL included difficulties with calibrations, frequent alarms, and the overall workload required to manage the system, indicating a need for interventions to support users, especially those with higher HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Messer, LH., Berget, C., Vigers, T., et al.[2021]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

The New-Onset Diabetes Educator (NODE) web application significantly improved diabetes knowledge among child/caregiver dyads, with post-intervention scores showing a medium effect size (Δ=0.56) compared to standard education methods.

NODE was found to be user-friendly and feasible, suggesting it could be an effective tool for enhancing diabetes self-management education at the time of diagnosis, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. Bernier, A., Fedele, D., Guo, Y., et al.[2023]

References

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

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. [2020]

2. Denmark pubmed.ncbi.nlm.nih.gov

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Impact of glycaemic technologies on quality of life and related outcomes in adults with type 1 diabetes: A narrative review. [2023]

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

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Care of children and adolescents with type 1 diabetes: solutions for technical and psychosocial challenges]. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Paediatric diabetes: information-seeking behaviours of families. [2015]

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

Effect of an Automated Advice Algorithm (CloudConnect) on Adolescent-Parent Diabetes-Specific Communication and Glycemic Management: A Randomized Trial. [2023]

10. Denmark pubmed.ncbi.nlm.nih.gov

Glycemic control in adolescents with type 1 diabetes: Are computerized simulations effective learning tools? [2022]