Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change in rise of HbA1c
研究概览
简要总结
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.
详细描述
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 1, a cohort of new-onset T1D participants (diagnosed 2020-2022) will receive the 4T new onset intervention, designed to decrease the rise in HbA1c seen from 4 to 12 months, with a weekly remote monitoring schedule, and will be compared to internal (4T Pilot - participants diagnosed with T1D between 2018-2020) and historical controls (patients diagnosed with T1D between 2014-2016).
In Study 2, a cohort of new-onsets T1D participants (diagnosed 2022-2024) 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 - participants diagnosed with T1D between 2018-2020 and 4T Study 1 - participants diagnosed with T1D between 2020-2022) and historical controls (patients diagnosed with T1D between 2014-2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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)
排除标准
- •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
研究组 & 干预措施
T1D Patients
Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring
干预措施: 4T Education and Care (Behavioral)
结局指标
主要结局
Change in rise of HbA1c
时间窗: Baseline, 6 months and 12 months post-diagnosis
Rise in HbA1c (a measure of blood sugar levels over the previous 3 months) as a measurement of the effect of 4T education and care. Collected through a blood sample.
次要结局
- Change in education exposure to safe exercise strategies(Baseline, 3, 6, and 9 months)
- Change Diabetes Distress Scale(Baseline, 3, 6, 9 and 12 months)
- Change in Diabetes Technology Attitude Scale(Baseline, 3, 6, 9 and 12 months)
- Change in Promise Global Health Scale(Baseline, 3, 6, 9 and 12 months)
- Change in Physical Activity, Youth Physical Activity Questionnaire (Y-PAQ)(Baseline, 3, 6 and 9 months)
- Change in participant Hypoglycemic Fear Scale(Baseline, 3, 6 and 9 months)
- Change in CGM Benefits and Burden Scale(Baseline, 3, 6, 9 and 12 months)
- Change in Parental Diabetes Distress Scale(Baseline, 3, 6, 9 and 12 months)
- Change in Physical Activity, International Physical Activity Questionnaire (IPAQ)(Baseline, 3, 6 and 9 months)
- Change in parent Hypoglycemic Fear Scale(Baseline, 3, 6 and 9 months)
- Change in Self-Efficacy for Exercise Scale(Baseline, 3, 6, and 9 months)
研究者
David Maahs
Chief of Pediatric Endocrinology
Stanford University