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Community Health Worker added to diabetes team for Type 1 Diabetes
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Waitlist Available
Led By Colin P Hawkes, MD PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if adding a Community Health Worker to healthcare teams improves diabetes control in kids with type 1 diabetes.
Who is the study for?
This trial is for children with type 1 diabetes for over a year, who've had multiple hospital visits or missed appointments, or have high Hemoglobin A1c levels. It's not open to children in state custody without a caretaker to manage study procedures.
What is being tested?
The study tests if adding a Community Health Worker to the child's diabetes care team can improve blood sugar control and reduce emergency visits, hospital stays, and missed appointments while also helping with psychosocial challenges.
What are the potential side effects?
There are no direct medical side effects from this intervention as it involves adding a support role to the healthcare team rather than testing new medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemoglobin A1c
Secondary study objectives
Attended outpatient appointments
Emergency Department utilization
Hospital admissions
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard Diabetes Care GroupExperimental Treatment1 Intervention
Patients receive standard diabetes care for one year. They receive a community health worker for the second year (as part of a crossover trial).
Group II: Community Health Worker GroupExperimental Treatment1 Intervention
Patients are assigned a community health worker for one year, in addition to standard diabetes care. They do not receive a community health worker for the second year of the study.
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
729 Previous Clinical Trials
8,469,708 Total Patients Enrolled
Colin P Hawkes, MD PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
28 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child in state custody without a caretaker for study procedures.I have been diagnosed with type 1 diabetes for over a year.In the past year, my diabetes-related hospital visits and missed appointments add up to more than 2, or my Hemoglobin A1c is at least 9.5.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Diabetes Care Group
- Group 2: Community Health Worker Group
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.
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