Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes

Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Middle School and High School Adolescents and Young Adults With Type 1 Diabetes

Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.

Groups:

1. Standard Care - No Group
2. Standard Care - Virtual Team Clinic Group
3. Team Clinic Care - No Group

4. Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)

   • Patients and parents will attend their own online session

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Team Clinic Care; Other: Standard Care

Detailed Description

Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience 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. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valerie Ruelas, MSW; Phone Number: 323-361-8416; Email: vruelas@chla.usc.edu
• Study Contact Backup: Name: Jaquelin Flores Garcia, BS, MPH; Phone Number: 14842 323-361-4842; Email: jfloresgarcia@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion

1. Diagnosis of type 1 diabetes > 6 month duration
2. Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
3. Not currently participating in other group interventions
4. English speaking

Exclusions

1. Severe behavioral or developmental disabilities in parent or child
2. Severe psychological diagnoses in parent or child that would make group participation difficult
3. Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
4. Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Team Clinic Care: No VTC Groups; 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	Other: Team Clinic Care; Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient. Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components: (1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment
Other: Team Clinic: Virtual Team Clinic Group; 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	Other: Team Clinic Care; Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient. Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components: (1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment
Other: Standard Care: No VTC Groups; 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).	Other: Standard Care; Participants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods.
Other: Standard Care: Virtual Team Clinic; 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	Other: Standard Care; Participants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C at Baseline	Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %	baseline to 12 months
Hemoglobin A1C Progression	HbA1c % At-Home Kit	At baseline (0), 3 months, 6 months, 9 months, 12 months
Number of Team Clinic Care cohort participants attending appointments	Attendance will be recorded for each Team Clinic visit	12 months
Number of Virtual Team Clinic Care cohort participants completing appointments	Attendance will be recorded for each Virtual Team Clinic Visit	12 months
Number of Team Clinic Care cohort participants completing appointments	Electronic Medical Record (EMR) Abstraction	12 months
Patient and Provider/Clinic Staff Satisfaction as assessed using the Health Care Climate questionnaire	Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction	12 months
Patient and Provider/Staff Satisfaction	Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.	12 months
Patient Experience	Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating	12 months
Social Determinants of Health Tool	Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"	At 0 (baseline)
Number of Standard Clinic cohort participants completing appointments	Attendance will be recorded for each standard care visit	12 months
Number of Standard Care cohort participants completing appointments	Electronic Medical Record (EMR) Abstraction	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Team Clinic Care cohort participants with diabetic ketoacidosis	Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR	12 months
Number of Standard Care cohort participants with diabetic ketoacidosis	Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR	12 months
Number of Team Clinic cohort participants with severe hypoglycemia	Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR	12 months
Number of Standard Care cohort participants with severe hypoglycemia	Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR	12 months
Diabetes Family Conflict Scale	Diabetes Family Conflict as assessed using the Diabetes Family Conflict Scale (DFCS) for parents and the DFCS for children. Each scale is a 20 item questionnaire using a Likert Scale (1 = Almost Never, 2 = Sometimes, 3 = Almost Always). Parent and Child questionnaires are combined with a possible score range from 40 to 120 with higher scores indicating more conflict.	At 0 (baseline) and 12 months (after visit 4)
Problem Areas in Diabetes in Caregivers	Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Caregivers (PAID-T). This instrument was designed to assess emotional distress related to caring for a teen with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.	At 0 (baseline) and 12 months (after visit 4)
Problem Areas in Diabetes in Teens	Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Teens (PAID-T). This instrument was designed to assess emotional distress in teens with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.	At 0 (baseline) and 12 months (after visit 4)
Patient - Practitioner Orientation Scale	Patient - Practitioner Orientation Scale consists of 18 items and 2 subscales. It assesses provider beliefs on patient centeredness. 6-point Likert scale: "Strongly disagree," "Moderately Disagree," "Slightly Disagree," "Slightly Agree," "Moderately Agree," and "Strongly Agree." PPOs score is computed by taking the mean of the 18 items with a minimum score being "1" and maximum being "6." Higher scores present more patient-centered attitudes.	At 0 (baseline) and 12 months (after visit 4)
Cost to Instituition	Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"	12 months
Cost to Institution - Standard care	Cost to Institution as assessed using the In Person questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person, standard care appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"	12 months
Cost to Institution - Team Clinic	Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to in person, Team Clinic care appointment. "Did you attend your in person appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"	12 months
Cost to Institution - Clinic Costs	Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient.	12 months
Cost to Institution - Team Costs	Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained (e.g. role), "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for Team Clinic appointment; training on, "roles of the attendees," in Team Clinic. Issues regarding the study and study toolkit.	12 months
Cost to Institution	Cost to Institution as assessed using the Feasibility and Usability of Toolkit questionnaire. Multiple choice questions used to identify the training session, role, provider, usability of toolkit, and training time. The questionnaire also includes a 6-point Likert scale: "Strongly disagree," "Somewhat Disagree," "Neutral," "Slightly Agree," "Somewhat Agree," and "Strongly Agree."	12 months
Clinical Efficiency	Assessed using the Clinical Efficiency questionnaire which captures the number of patients seen during a given time period), team members seen, and time patients spent with team members.	12 months
Diabetes Strengths and Resilience Measure for Children	DSTAR-Child assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.	At 0 (baseline) and 12 months (after visit 4)
Diabetes Strengths and Resilience Measure for Teens	DSTAR-Teen assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.	At 0 (baseline) and 12 months (after visit 4)
PROMIS - Peds Peer Relationships	Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Peer Relationships. Evaluates and monitors social health. Likert scale used to assess quality of relationships with friends and acquaintances. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)	At 0 (baseline) and 12 months (after visit 4)
PROMIS - Peds Family Relationships	Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Family Relationships. Evaluates and monitors social health. Likert scale used to assess the subjective (affective, emotional, cognitive) experience of being involved with one's family, feeling like an important person in the family, of feeling accepted and cared for, and feeling that family members, especially parents, can be trusted and depended on for help and understanding. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)	At 0 (baseline) and 12 months (after visit 4)
PROMIS - Emotional Support	Patient-Reported Outcomes Measurement Information System (PROMIS )- Emotional Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing perceived feelings of being cared for and valued as a person; having confidant relationships. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)	At 0 (baseline) and 12 months (after visit 4)
PROMIS - Instrumental Support	Patient-Reported Outcomes Measurement Information System (PROMIS )- Instrumental Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of assistance with material, cognitive or task performance. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)	At 0 (baseline) and 12 months (after visit 4)
PROMIS - Informational Support	Patient-Reported Outcomes Measurement Information System (PROMIS )- Informational Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of helpful information or advice.. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)	At 0 (baseline) and 12 months (after visit 4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-Demographic History	Self-reported demographic history (gender, age, race, household income, etc) will be collected.	At 0 (baseline)
Medical History	General health history via self report and EMR	12 months
Diabetes Treatment Regimen - glucometer	Diabetes treatment regimen assessed through blood glucose checks per day from glucometer downloads will be collected from devices and EMR.	12 months
Diabetes Treatment Regimen - insulin pump	Diabetes treatment regimen assessed through insulin boluses per day from insulin pump downloads will be collected from devices and EMR.	12 months
Diabetes Treatment Regimen - continuous glucose monitors	Diabetes treatment regimen assessed through percentage of glucose values low, in target, or high for patients on continuous glucose monitors will be collected from devices and EMR.	12 months
Self-care and mobility as assessed using the EuroQOL five dimensions five levels youth (EQ-5D-Y) questionnaire	Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.	At 0 (baseline) and 12 months (after visit 4)
The Child Health Utility	The Child Health Utility 9 dimensions assesses health-related quality of life (HRQoL). Multiple choice used to capture respondents' endorsement of particular statements about experience. "I don't feel [upset] today," "I feel a little bit [upset] today," "I feel a bit [upset] today," "I feel quite [upset] today," "I feel very [upset] today"	At 0 (baseline) and 12 months (after visit 4)
Patient Health Questionnaire-8 (PHQ-8)	Composed of 8 items to screen, diagnose, and measure the severity of depression.	At 0 (baseline) and 12 months (after visit 4)
Shared Medical Appointments - Patient/AYA	Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments.	baseline to 12 months
Shared Medical Appointments- Parent/caregiver	Likert scale;"Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments.	baseline to 12 months
Self Care - Related to Diabetes as assessed by Self-Care questionnaire	Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"	baseline to 12 months
Diabetes Family Responsbility Questionnaire - Parent	Asseses how adolescents with T1D and their families/caregivers share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management.	At 0 (baseline) and 12 months (after visit 4)
Diabetes Family Responsbility Questionnaire - Teen	Asseses how parents/caregivers of children/teens living with T1D share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management.	At 0 (baseline) and 12 months (after visit 4)
Clinical Variables	Polar; Yes or No questionnaire. Data extracted from EMR : cholesterol, high density lipoprotein, triglycerides, smoking status, nephropathy, microalbuminaria, macroalbuminaria, end-stage renal disease (death from end-stage renal disease), neuropathy, peripheral arterial disease (low extremity amputation), retinopathy (proliferative retinopathy), macular edema, blindness, angina, myocardial infarction, stroke, heart failure, revascularization (Coronary artery bypass grafting, PCA, and stenting). If answered "yes" for the following: ergosterol, HDL,microalbuminaria, and macroalbuminaria, values will be recorded.	At 0 (baseline) and 12 months (after visit 4)
ADA and CCS standards	EMR abstraction: Questions assess compliance with ADA and CCS standards when patients have contact with all team members annually. This will be noted with polar questions "Yes" or No." This will be tracked for all patients in the study (e.g., Team Clinic and Standard Clinic).	12 months
Single Item Literacy Scale	Literacy assessed using the Single Item Literacy Scale. Multiple choice question asking about suppoort needed with reading materials. Options, "never," "rarely," "sometimes," "often," "always"	At 0 (Baseline) and 12 months (after visit 4)
Provider Centered Care Observation Form (PCOF)	Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintain Relationship Throughout the Visit," "Collaborative upfront agenda setting," "Maintain Efficiency using transparent thinking and respectful interruption," "Gathering information," "Assessing patient or family perspective on health," "Electronic Medical Record Use," "Physical Exam"	12 months
Facilitator Centered Care Observation Form (PCOF)	Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintains Relationship Trhoughout the Visit," "Session Introduction and Icebreaker," "Session Preparation," "Gathering Information," "Assessing Patient or Family Persepctive on Health/Understanding Context," "Blood Glucose Charting," "Blood Glucose Discussion," "Activity Kit Review"	12 months
Provider/Facilitator Session Feedback Form:	Assess provider experience during clinic visit and patient-center delivery. Multiple choice, "Establishing Rapport and Maintaining Relationship," "Agenda-setting, Thinking Out-Loud, and Collaboration," "Gathering Information and Understanding Context," "EMR Review and Physical Exam," "Promoting Behavior Change or Self-Management," "Collaborative Planning and Closure," "None of these"	12 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: University of Southern California; Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Jennifer K Raymond, MD, MCR, Children's Hospital Los Angeles

Publications and helpful links

General Publications

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• Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.
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• McClain MR, Klingensmith GJ, Anderson B, Berget C, Cain C, Shea J, Campbell K, Pyle L, Raymond JK. Team Clinic: Group Approach to Care of Early Adolescents With Type 1 Diabetes. Diabetes Spectr. 2018 Aug;31(3):273-278. doi: 10.2337/ds17-0063. No abstract available.
• Raymond JK. Models of Care for Adolescents and Young Adults with Type 1 Diabetes in Transition: Shared Medical Appointments and Telemedicine. Pediatr Ann. 2017 May 1;46(5):e193-e197. doi: 10.3928/19382359-20170425-01.
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• Palladino DK, Helgeson VS. Friends or foes? A review of peer influence on self-care and glycemic control in adolescents with type 1 diabetes. J Pediatr Psychol. 2012 Jun;37(5):591-603. doi: 10.1093/jpepsy/jss009. Epub 2012 Mar 29.
• Chiang JL, Kirkman MS, Laffel LM, Peters AL; Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care. 2014 Jul;37(7):2034-54. doi: 10.2337/dc14-1140. No abstract available.
• Salvy SJ, Ruelas V, Majidi S, Thomas A, Ashwal G, Reid M, Fox DS, McClain S, Raymond JK. Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes. Contemp Clin Trials. 2020 Aug;95:106079. doi: 10.1016/j.cct.2020.106079. Epub 2020 Jul 4.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Young Adults; Group Medical Visits
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CHLA-19-00062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Development, execution, and data collection for this study is completed with a Principle Investigator at Children's Hospital Los Angeles. With documented permission of the IRB, a PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested Investigators will complete a request form stating the aims of their analyses, analytic plan, available resources for completing a project, timeline, and goals (i.e. manuscripts or grant applications). The PIs and their research team will review requests to determine whether the analyses constitute an innovative exploration of the data, whether the team has resources to complete the request, and whether data will be adequately protected and managed. If issues arise, the PIs and research team will negotiate a fair resolution with interested investigators and NIH staff.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed, and requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No