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Behavioral Intervention
FAMS-T1D + Digital Resources for Type 1 Diabetes
N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with T1D and has been taking insulin for at least one year
Persons with diabetes aged 18-24
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-baseline
Awards & highlights
Study Summary
This trial will look at how Family/friend Activation helps people with type 1 diabetes better use their CGM and lower their A1c. 280 people with elevated hemoglobin A1c & diabetes distress will be involved. 50% will be CGM users.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves behavioral interventions and digital resources rather than medications, traditional side effects are not expected. However, participants may experience increased stress or anxiety from regular monitoring and communication requirements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Type 1 Diabetes and have been on insulin for over a year.
Select...
I am between 18 and 24 years old and have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CGM frequency of use during the intervention period
Gaps in CGM use
Secondary outcome measures
Barriers to CGM use during the intervention period
CGM behavioral responses during the intervention period
CGM satisfaction during the intervention period
Other outcome measures
Data sharing during the intervention period
Satisfaction with data-sharing relationships
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FAMS-T1DExperimental Treatment2 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 diabetesPlacebo Group1 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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,052 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,778 Total Patients Enrolled
University of UtahOTHER
1,095 Previous Clinical Trials
1,775,445 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes but no severe mental illness, blindness, or hearing problems that would stop me from completing the study.I have Type 1 Diabetes and have been on insulin for over a year.My support person is 18 years old or older.I can speak, read, and write in English or Spanish.You have diabetes and plan to live in another country during the study.I am between 18 and 24 years old and have diabetes.People who live with someone who has diabetes and share the same phone.Your recent A1c test shows a value of 7.5% or higher, or is missing, or you have shown signs of diabetes distress on a screening test.You are currently wearing a continuous glucose monitor (CGM).
Research Study Groups:
This trial has the following groups:- Group 1: FAMS-T1D
- Group 2: Digital resources for diabetes
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial cater to elderly individuals?
"Based on the qualifications for this research, only candidates between 18 and 24 years old can be included in the trial."
Answered by AI
To whom is participation in this research open?
"In order to gain entry into this trial, applicants must be between 18 and 24 years old with a diagnosis of type 1 diabetes. A total of 140 individuals are invited to take part in the study."
Answered by AI
Are there currently any openings for volunteers in this experiment?
"According to clinicaltrials.gov, this research endeavour is actively seeking volunteers for participation; the trial was initially announced on April 4th 2023 and was most recently updated May 9th of the same year."
Answered by AI
How many participants have enrolled in this research endeavor?
"Affirmative. The trial's details, which were first disseminated on April 4th 2023 and subsequently edited May 9th of the same year, are visible on clinicaltrials.gov and confirm that this medical research is actively recruiting 140 participants from a single site."
Answered by AI
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