Type 1 Diabetes Clinical Trial
Official title:
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
Verified date | April 2024 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 79 |
Est. completion date | September 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | Cedars-Sinai Medical Center, University of Southern California |
United States,
American Diabetes Association. Erratum. Glycemic Targets. Sec. 6. In Standards of Medical Care in Diabetes-2017. Diabetes Care 2017;40(Suppl. 1);S48-S56. Diabetes Care. 2017 Jul;40(7):985. doi: 10.2337/dc17-er07a. Epub 2017 May 18. No abstract available. — View Citation
Berget C, Lindwall J, Shea JJ, Klingensmith GJ, Anderson BJ, Cain C, Raymond JK. Team Clinic: An Innovative Group Care Model for Youth with Type 1 Diabetes-Engaging Patients and Meeting Educational Needs. J Nurse Pract. 2017 Jun;13(6):e269-e272. doi: 10.1016/j.nurpra.2017.03.016. Epub 2017 Apr 26. — View Citation
Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052. — View Citation
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. — View Citation
Continous Glucose Monitoring (CGM) as a CCS/GHPP Program Benefit [press release]. 3/6/2017.
Evans M, Davis, L, & Weissberg-Benchell, J. Psychometric properties of the child and parent problem areas in diabetes measures. Paper presented at: Poster presented at the 76th Annual Scientific Sessions of the American Diabetes AssociationJune, 2016; New Orleans, Louisiana.
Floyd BD, Block JM, Buckingham BB, Ly T, Foster N, Wright R, Mueller CL, Hood KK, Shah AC. Stabilization of glycemic control and improved quality of life using a shared medical appointment model in adolescents with type 1 diabetes in suboptimal control. Pediatr Diabetes. 2017 May;18(3):204-212. doi: 10.1111/pedi.12373. Epub 2016 Feb 26. — View Citation
Hays RD, Shaul JA, Williams VS, Lubalin JS, Harris-Kojetin LD, Sweeny SF, Cleary PD. Psychometric properties of the CAHPS 1.0 survey measures. Consumer Assessment of Health Plans Study. Med Care. 1999 Mar;37(3 Suppl):MS22-31. doi: 10.1097/00005650-199903001-00003. — View Citation
Hilliard ME, Harris MA, Weissberg-Benchell J. Diabetes resilience: a model of risk and protection in type 1 diabetes. Curr Diab Rep. 2012 Dec;12(6):739-48. doi: 10.1007/s11892-012-0314-3. — View Citation
Hood KK, Butler DA, Anderson BJ, Laffel LM. Updated and revised Diabetes Family Conflict Scale. Diabetes Care. 2007 Jul;30(7):1764-9. doi: 10.2337/dc06-2358. Epub 2007 Mar 19. — View Citation
Kahana S, Drotar D, Frazier T. Meta-analysis of psychological interventions to promote adherence to treatment in pediatric chronic health conditions. J Pediatr Psychol. 2008 Jul;33(6):590-611. doi: 10.1093/jpepsy/jsm128. Epub 2008 Jan 11. — View Citation
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. — View Citation
Mejino A, Noordman J, van Dulmen S. Shared medical appointments for children and adolescents with type 1 diabetes: perspectives and experiences of patients, parents, and health care providers. Adolesc Health Med Ther. 2012 Jun 15;3:75-83. doi: 10.2147/AHMT.S32417. eCollection 2012. — View Citation
Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078. — View Citation
Morris NS, MacLean CD, Chew LD, Littenberg B. The Single Item Literacy Screener: evaluation of a brief instrument to identify limited reading ability. BMC Fam Pract. 2006 Mar 24;7:21. doi: 10.1186/1471-2296-7-21. — View Citation
Noffsinger E. Enhance satisfaction with drop-in group visits. . Hippocrates. 2001;15(2):30-36.
Noffsinger EB. Running Group Visits in Your Practice. New York, NY: Springer Science+Business Media; 2009.
Noordman J, van Dulmen S. Shared Medical Appointments marginally enhance interaction between patients: an observational study on children and adolescents with type 1 diabetes. Patient Educ Couns. 2013 Sep;92(3):418-25. doi: 10.1016/j.pec.2013.06.008. Epub 2013 Jul 3. — View Citation
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. — View Citation
Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available. Erratum In: Diabetes Care. 2012 Jan;35(1):191. — View Citation
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. — View Citation
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. — View Citation
Reiss J, Gibson R. Health care transition: destinations unknown. Pediatrics. 2002 Dec;110(6 Pt 2):1307-14. — View Citation
Rijswijk C, Zantinge E, Seesing F, Raats I, van Dulmen S. Shared and individual medical appointments for children and adolescents with type 1 diabetes; differences in topics discussed? Patient Educ Couns. 2010 Jun;79(3):351-5. doi: 10.1016/j.pec.2010.04.016. Epub 2010 May 2. — View Citation
Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. doi: 10.1016/s0091-2182(97)00117-1. — View Citation
Rosen DS, Blum RW, Britto M, Sawyer SM, Siegel DM; Society for Adolescent Medicine. Transition to adult health care for adolescents and young adults with chronic conditions: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2003 Oct;33(4):309-11. doi: 10.1016/s1054-139x(03)00208-8. No abstract available. — View Citation
Rubin RY-H, D; Peyrot, M. Parent-child responsibility and conflict in diabetes care (Abstract) Diabetes Care. 1989;38:28A.
Sanchez I. Implementation of a diabetes self-management education program in primary care for adults using shared medical appointments. Diabetes Educ. 2011 May-Jun;37(3):381-91. doi: 10.1177/0145721711401667. Epub 2011 Mar 31. — View Citation
Weissberg-Benchell J, Antisdel-Lomaglio J. Diabetes-specific emotional distress among adolescents: feasibility, reliability, and validity of the problem areas in diabetes-teen version. Pediatr Diabetes. 2011 Jun;12(4 Pt 1):341-4. doi: 10.1111/j.1399-5448.2010.00720.x. Epub 2011 Mar 28. — View Citation
Whittemore R, Jaser S, Chao A, Jang M, Grey M. Psychological experience of parents of children with type 1 diabetes: a systematic mixed-studies review. Diabetes Educ. 2012 Jul-Aug;38(4):562-79. doi: 10.1177/0145721712445216. Epub 2012 May 11. — View Citation
Willi SM, Miller KM, DiMeglio LA, Klingensmith GJ, Simmons JH, Tamborlane WV, Nadeau KJ, Kittelsrud JM, Huckfeldt P, Beck RW, Lipman TH; T1D Exchange Clinic Network. Racial-ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics. 2015 Mar;135(3):424-34. doi: 10.1542/peds.2014-1774. — View Citation
Winkley K, Ismail K, Landau S, Eisler I. Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. BMJ. 2006 Jul 8;333(7558):65. doi: 10.1136/bmj.38874.652569.55. Epub 2006 Jun 27. — View Citation
* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Socio-Demographic History | Self-reported demographic history (gender, age, race, household income, etc) will be collected. | At 0 (baseline) | |
Other | Medical History | General health history via self report and EMR | 12 months | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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) | |
Other | 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) | |
Other | 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) | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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) | |
Other | 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) | |
Other | 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) | |
Other | 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 | |
Other | 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) | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Primary | Hemoglobin A1C at Baseline | Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) % | baseline to 12 months | |
Primary | Hemoglobin A1C Progression | HbA1c % At-Home Kit | At baseline (0), 3 months, 6 months, 9 months, 12 months | |
Primary | Number of Team Clinic Care cohort participants attending appointments | Attendance will be recorded for each Team Clinic visit | 12 months | |
Primary | Number of Virtual Team Clinic Care cohort participants completing appointments | Attendance will be recorded for each Virtual Team Clinic Visit | 12 months | |
Primary | Number of Team Clinic Care cohort participants completing appointments | Electronic Medical Record (EMR) Abstraction | 12 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | Number of Standard Clinic cohort participants completing appointments | Attendance will be recorded for each standard care visit | 12 months | |
Primary | Number of Standard Care cohort participants completing appointments | Electronic Medical Record (EMR) Abstraction | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|
||
Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 | |
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |