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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

Must not have

Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)

Severe psychological diagnoses in parent or child that would make group participation difficult

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major health issues like cystic fibrosis or uncontrolled thyroid disease.

Select...

Either my child or I have a severe mental health condition that makes group activities challenging.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1C Progression

Hemoglobin A1C at Baseline

Number of Standard Care cohort participants completing appointments

+8 more

Secondary study objectives

Clinical Efficiency

Cost to Instituition

Cost to Institution

+19 more

Other study objectives

ADA and CCS standards

Clinical Variables

Diabetes Family Responsbility Questionnaire - Parent

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met