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Completed

NCT Number: NCT04336969

Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study

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.

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Key information

Conditions

Type1diabetes

Age range

6 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franziska Katherine Bishop

Steamboat Springs, Colorado, 80487, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4T Education and Care

Behavioral

CGM data will be used to create customized weekly or monthly feedback to the participant/family by secure MyChart message.

Primary outcomes

  1. Change in rise of HbA1c

    Time frame: 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.

Secondary outcomes

  1. Change in CGM Benefits and Burden Scale

    Time frame: Baseline, 3, 6, 9 and 12 months

    This tool measures the benefits and burden of Continuous Glucose Monitor (CGM) device use, and is reported by participants.

    PERCEIVED BENEFITS OF CGM SCALE (BenCGM):

    Below is a list of things people might think are good about wearing a CGM.

    5 - Strongly agree 4 -Agree 3 - Neutral 2 - Disagree

    1 - Strongly disagree

  2. Change Diabetes Distress Scale

    Time frame: Baseline, 3, 6, 9 and 12 months

    This measure is widely used to capture the psychological distress experienced in relation to diabetes, and is reported by participants.

    Score Range: 0-4 Interpretation: Higher scores indicates higher distress, a worse outcome

    • Not a Problem
    • A Slight Problem
    • A Moderate Problem
    • Somewhat Serious Problem
    • A Serious Problem
    • A Very Serious Problem

  3. Change in Diabetes Technology Attitude Scale

    Time frame: Baseline, 3, 6, 9 and 12 months

    This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices, and is reported by participants.

    Tool lists statement and participants reports how much they agree with the statement.

    1 2 3 4 5 Strongly disagree Disagree Neutral Agree Strongly agree

  4. Change in Parental Diabetes Distress Scale

    Time frame: Baseline, 3, 6, 9 and 12 months

    The Parental Diabetes Distress Scale (PARENT-DDS) measure is widely used to capture the psychological distress experienced by parents in relation to diabetes, and is reported by participants.

    Score Range: 0-4 Interpretation: Higher scores indicates higher distress, a worse outcome

    • Not a Problem
    • A Slight Problem
    • A Moderate Problem
    • Somewhat Serious Problem
    • A Serious Problem
    • A Very Serious Problem

  5. Change in Promise Global Health Scale

    Time frame: Baseline, 3, 6, 9 and 12 months

    This measure is widely used to capture general and overall health, and is reported by participants.

    PROMISE GLOBAL HEALTH SCALES

    5, Excellent | 4, Very Good | 3, Good | 2, Fair | 1, Poor

  6. Change in Physical Activity, Youth Physical Activity Questionnaire (Y-PAQ)

    Time frame: Baseline, 3, 6 and 9 months

    Youth Physical Activity Questionnaire (Y-PAQ) is a measure used to determine overall physical activity in the last 7 days, and is reported by participants.

    Score Range: 1 to 3. Interpretation: Higher scores indicate higher levels of physical activity, a better outcome.

  7. Change in Physical Activity, International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline, 3, 6 and 9 months

    International Physical Activity Questionnaire (IPAQ) asks about physical activity and sedentary behavior in the last 7 days, and is reported by participants.

    Score Range: 1 to 3. Interpretation: Higher scores indicate higher levels of physical activity, a better outcome.

  8. Change in participant Hypoglycemic Fear Scale

    Time frame: Baseline, 3, 6 and 9 months

    People with diabetes worry about hypoglycemia. Hypoglycemic Fear Survey (HFS-II) measure captures those worries and is reported by participants.

    Score Range: 0-4 Interpretation: Higher scores indicates higher levels of stress, a worse outcome

  9. Change in parent Hypoglycemic Fear Scale

    Time frame: Baseline, 3, 6 and 9 months

    Parents of children with diabetes worry about hypoglycemia. Hypoglycemic Fear Survey (HFS-P) measure captures those worries and is reported by parents of participants.

    Score Range: 0-4 Interpretation: Higher scores indicates higher levels of stress, a worse outcome

  10. Change in Self-Efficacy for Exercise Scale

    Time frame: Baseline, 3, 6, and 9 months

    Self-Efficacy for Exercise (SEE) Scale measures how confident people are in their ability to overcome barriers to exercise.

    Total scale is calculated by summing the responses to each question. The scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

  11. Change in education exposure to safe exercise strategies

    Time frame: Baseline, 3, 6, and 9 months

    Percentage of participants attending at least one telehealth session and a measure of education exposure to safe exercise strategies

Other outcomes

  1. 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

    Time frame: 4-12 month trajectory in study 2

    Newly diagnosed T1D patients receiving 4T education and care monitored on a step-down cadence will H1a) achieve a 4-12 month change in HbA1c noninferior to that achieved under weekly review by a margin of 0.1 among 4T Pilot and 4T Study 1 patients and H1b) achieve a lower 4-12 month trajectory relative to external contemporary controls.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2020
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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