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Group Visits for Type 1 Diabetes
N/A
Recruiting
Led By Shideh Majidi, MD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Poorly controlled T1D: one A1c value > 8% in the preceding year
Patients clinically diagnosed with T1D managed with insulin injections for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Awards & highlights
Study Summary
This trial will assess if shared medical appointments help underserved youth with poorly controlled type 1 diabetes in terms of glycemic control, self-management skills, and health related quality of life.
Who is the study for?
This trial is for underserved youth aged 8-11 with poorly controlled type 1 diabetes (T1D), who have public healthcare insurance, speak English, and are managed on insulin injections. Participants must be Non-Hispanic Black or Latinx and have had an A1c value over 8% in the past year. Those using insulin pumps, with significant cognitive issues or major psychiatric disorders, taking non-insulin diabetes meds, or involved in other studies can't join.Check my eligibility
What is being tested?
The study tests shared medical appointments (SMA) every three months for one year to see if they help improve blood sugar control, self-care skills, and quality of life in these kids. After the SMA visits end, there's a six-month observation period to evaluate how well SMAs work and if people like this approach.See study design
What are the potential side effects?
Since this trial focuses on group medical visits rather than a new medication or treatment device, traditional side effects aren't expected. However, participants may experience stress or discomfort from discussing their condition in a group setting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diabetes control has been poor, with an A1c over 8% in the last year.
Select...
I have been managing my Type 1 Diabetes with insulin injections for over a year.
Select...
I am between 8 and 11 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of SMA sessions attended, as assessed by tracking study visit attendance.
Perceived benefit of the SMA intervention content, as measured by user satisfaction surveys summary statistics (mean and standard deviation as well as percent answering a specific Likert level)
Perceived satisfaction of SMA intervention as assessed by user satisfaction surveys summary statistics (mean and standard deviation as well as percent answering a specific Likert level), and semi-structured interviews.
+3 moreSecondary outcome measures
CGM Benefits and Burdens scale
Diabetes Self-Management Profile (DSMP) survey
Problem Areas in Diabetes (PAID) scale
+13 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SMA visit intervention armExperimental Treatment1 Intervention
SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver
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Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
211 Previous Clinical Trials
208,137 Total Patients Enrolled
American Diabetes AssociationOTHER
137 Previous Clinical Trials
99,482 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,830 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The child has severe problems with thinking or major mental health issues.My diabetes control has been poor, with an A1c over 8% in the last year.You have significant health conditions other than type 1 diabetes.I have been managing my Type 1 Diabetes with insulin injections for over a year.I am between 8 and 11 years old.I use an insulin pump to manage my diabetes.You are not Black or of Latin American descent.I am using non-insulin medication to manage my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: SMA visit intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any vacancies in this medical experiment for participants?
"The information posted on the clinicaltrials.gov website demonstrates that this study is presently recruiting participants, with its initial posting occurring on February 16th 2022 and last update taking place in late August of the same year."
Answered by AI
What is the participant enrollment cap for this clinical investigation?
"Indeed, the clinicaltrials.gov website confirms that recruitment for this medical trial is still ongoing; commencing on February 16th 2022 and most recently updated on August 26th 2022. 20 individuals are needed from one single site to take part in the study."
Answered by AI
What is the intention of this experiment?
"DexCom, Inc., the trial sponsor, has stated that their primary measured outcome will be Participant satisfaction of SMA intervention as assessed by user surveys and semi-structured interviews over a 12 month period. Secondary outcomes include: Continuous Glucose Monitor Time within 70-180 mg/dL range; Episodes of Diabetic Ketoacidosis since last study visit; and CGMs Coefficient of Variation across the SMA Intervention & Follow Up Periods."
Answered by AI
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