Clinical trial NCT04336969: Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
Official title: Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-07
Enrollment: 316
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The 4T program encompasses: Teamwork, Targets, Technology, and Tight Range. These methods will help patients better manage their condition of Type 1 Diabetes with improved patient-reported outcomes.

Detailed description: The goal of the 4T study is to implement proven methods and emerging diabetes technology into the investigator's clinical practice to sustain a tight glucose range from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will define a program (4T - Teamwork, Targets, Technology, and Tight Range) translatable to Pediatric Diabetes clinics in the United States that reduces HbA1c and T1D burden and improves patient well-being.

Study Design: This is a prospective, open-label, pragmatic research study. Two related studies will be performed. In Study 2, a cohort of new onsets (183) receiving the 4T new onset intervention designed to decrease the rise in HbA1c seen from 4 to 12 months but following a tapered (from weekly to monthly) remote monitoring schedule will be compared to internal (4T Pilot and 4T Study 1) and external contemporaneous controls (CMH and DPV).

Eligibility criteria: Inclusion Criteria: (Inclusion criteria includes all youth with new onset T1D seen in the Stanford/Lucile Packard Children's Hospital ages 6 months-21 years of age. We intend to include all possible patients with the goal of maximizing generalizability of the results and 4T program. (NOTE: We will include children and families who speak all languages using the Stanford interpreter services so as to have the greatest generalizability of the research. Questionnaires will only be given to English and Spanish speakers.)

* All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic
* Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic
* Individuals who agree to CGM data integration into the EMR for remote monitoring
* Age: six months to \< 21 years of age
* Patient or guardian must own and operate an Apple compatible device (e.g., iPhone or iPod Touch) to allow for the Dexcom app and CGM data transmission to the hospital server-based remote monitoring system.

Dr Prahalad's LPCH Auxiliary Fund grant (in addition to the R18) has resources to support iPod Touch/iPhone purchases for participants who do not have these.

o For the Exercise Ancillary study: 11 to \< 21 years of age (the activity tracker is not validated for younger children) English and Spanish-Speaking (Study 2)

Exclusion Criteria:

* Diabetes diagnosis other than T1D
* Diagnosis of diabetes \> one month prior to initial visit
* Individuals with the intention of obtaining diabetes care at another clinic
* Individuals who do not consent to CGM use, CGM data integration, remote monitoring
* Individuals \> 21 years of age

Primary outcomes:
measure: Change in rise of HbA1c
timeFrame: Baseline, 6 months and 12 months post-diagnosis
Secondary outcomes:
measure: Change in CGM Benefits and Burden Scale
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change Diabetes Distress Scale
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in Diabetes Technology Attitude Scale
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in Parental Diabetes Distress Scale
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in Promise Global Health Scale
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in Physical Activity, Youth Physical Activity Questionnaire (Y-PAQ)
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Physical Activity, International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in participant Hypoglycemic Fear Scale
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in parent Hypoglycemic Fear Scale
timeFrame: Baseline, 3, 6 and 9 months
measure: Change in Self-Efficacy for Exercise Scale
timeFrame: Baseline, 3, 6, and 9 months
measure: Change in education exposure to safe exercise strategies
timeFrame: Baseline, 3, 6, and 9 months
Other outcomes:
measure: T1D Patients receiving 4T education and care monitored on a step-down cadence in study 2, will achieve an HBA1c non-inferior to weekly review
timeFrame: 4-12 month trajectory in study 2
Locations:
city: Steamboat Springs
country: United States
facility: Franziska Katherine Bishop
state: Colorado
Study officials:
affiliation: Lucile Packard Children's Hospital; Stanford University, School of Medicine
name: David M Maahs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prahalad P, Scheinker D, Desai M, Ding VY, Bishop FK, Lee MY, Ferstad J, Zaharieva DP, Addala A, Johari R, Hood K, Maahs DM. Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes. Nat Med. 2024 Jul;30(7):2067-2075. doi: 10.1038/s41591-024-02975-y. Epub 2024 May 3.