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Team Clinic Care for Type 1 Diabetes

N/A

Waitlist Available

Led By Jennifer K Raymond, MD, MCR

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 1 diabetes > 6 month duration

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (0), 3 months, 6 months, 9 months, 12 months

Awards & highlights

Study Summary

This trial is to study if the team clinic care model is more effective than standard care for patients with T1D.

Who is the study for?

This trial is for English-speaking middle and high school students with Type 1 Diabetes, who have been diagnosed for over 6 months. They shouldn't be in other group interventions or have serious medical conditions like cystic fibrosis, uncontrolled thyroid disease, or severe behavioral/psychological issues that could affect group participation.Check my eligibility

What is being tested?

The study tests a new 'Team Clinic' care approach against standard care for managing Type 1 Diabetes. It involves virtual appointments and possibly in-person visits with a multidisciplinary team. Participants are randomly placed into one of four groups to compare the effects of these different approaches over 15 months.See study design

What are the potential side effects?

Since this trial focuses on diabetes management through virtual care rather than medication, traditional side effects aren't expected. However, participants may experience varying levels of satisfaction or effectiveness with the virtual healthcare model.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with type 1 diabetes for over 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (0), 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (0), 3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (0), 3 months, 6 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemoglobin A1C Progression

Hemoglobin A1C at Baseline

Number of Standard Care cohort participants completing appointments

+8 more

Secondary outcome measures

Clinical Efficiency

Cost to Instituition

Cost to Institution

+19 more

Other outcome measures

ADA and CCS standards

Clinical Variables

Diabetes Family Responsbility Questionnaire - Parent

+16 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Team Clinic: Virtual Team Clinic GroupExperimental Treatment1 Intervention

Participants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

Group II: Team Clinic Care: No VTC GroupsExperimental Treatment1 Intervention

Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed • Providers will utilize a patient centered care approach to conducting appointments

Group III: Standard Care: Virtual Team ClinicExperimental Treatment1 Intervention

Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

Group IV: Standard Care: No VTC GroupsExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,393 Total Patients Enrolled

University of Southern CaliforniaOTHER

906 Previous Clinical Trials

1,596,209 Total Patients Enrolled

Cedars-Sinai Medical CenterOTHER

500 Previous Clinical Trials

164,820 Total Patients Enrolled

Media Library

Standard Care Clinical Trial Eligibility Overview. Trial Name: NCT04190368 — N/A

Type 1 Diabetes Research Study Groups: Team Clinic: Virtual Team Clinic Group, Team Clinic Care: No VTC Groups, Standard Care: Virtual Team Clinic, Standard Care: No VTC Groups

Type 1 Diabetes Clinical Trial 2023: Standard Care Highlights & Side Effects. Trial Name: NCT04190368 — N/A

Standard Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04190368 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of involvement in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov displays that this examination, which was first published on September 7th 2021, is actively enrolling individuals. Approximately 200 patients need to be recruited from one medical centre."

Answered by AI

What is the expected outcome of this trial?

"The primary objective of this medical trial, which will be evaluated over the course of 12 months, is to examine the number of standard care cohort participants that complete appointments. Additional objectives include evaluating cost to institution for those receiving in-person treatment; a polar yes or no questionnaire inquiring about appointment attendance and duration; self-reported episodes of diabetic ketoacidosis in past three months as well as Electronic Medical Records (EMR); and Problem Areas in Diabetes instrument designed to assess emotional distress related caregivers with teens suffering from diabetes using a 6 point Likert Scale format."

Answered by AI

What criteria must an individual possess to be eligible for participation in this experiment?

"This study aims to recruit 200 minors (aged 10-17) with type 1 diabetes mellitus. The essential eligibility criteria for applicants are the following: Behavioural or developmental disabilities in parent/child, Mental health conditions which make group participation challenging, Grade level from 6th to 12th at time of intervention, No prior involvement in other group interventions and exclusion due to severe comorbid medical issues (like cystic fibrosis)."

Answered by AI

Does the medical trial accept elderly individuals as participants?

"This clinical trial requires that participants range in age from 10 to 17. In addition, there are 218 studies for minors and 925 for adults of senior years."

Answered by AI

Does this medical study currently accept participants?

"Correct. According to the information publicly available on clinicaltrials.gov, this medical research is actively recruiting participants since its initial posting date of September 7th 2021, and has a goal of 200 patients from one location."

Answered by AI

Recent research and studies

Diabetes CareJournal

Current State of Type 1 Diabetes Treatment in the U.S.: Updated Data from the T1D Exchange Clinic Registry

Miller, Kellee M., Nicole C. Foster, Roy W. Beck, Richard M. Bergenstal, Stephanie N. DuBose, Linda A. DiMeglio, David M. Maahs, and William V. Tamborlane. 2015. “Current State of Type 1 Diabetes Treatment in the U.S.: Updated Data from the T1D Exchange Clinic Registry”. Diabetes Care. American Diabetes Association. doi:10.2337/dc15-0078.

Diabetes CareJournal

Updated and Revised Diabetes Family Conflict Scale

Hood, Korey K., Deborah A. Butler, Barbara J. Anderson, and Lori M.B. Laffel. 2007. “Updated and Revised Diabetes Family Conflict Scale”. Diabetes Care. American Diabetes Association. doi:10.2337/dc06-2358.

Diabetes SpectrumJournal

Team Clinic: Group Approach to Care of Early Adolescents with Type 1 Diabetes

McClain, Megan Rose, Georgeanna J. Klingensmith, Barbara Anderson, Cari Berget, Cindy Cain, Jacqueline Shea, Kristen Campbell, Laura Pyle, and Jennifer K. Raymond. 2018. “Team Clinic: Group Approach to Care of Early Adolescents with Type 1 Diabetes”. Diabetes Spectrum. American Diabetes Association. doi:10.2337/ds17-0063.

Diabetes CareJournal