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

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ClinicalTrials.gov Identifier: NCT04336969
Recruitment Status : Enrolling by invitation
First Posted : April 7, 2020
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Maahs, Stanford University

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

Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: 4T Education and Care Not Applicable

Detailed Description:
The goal of the 4T study is to implement proven methods and emerging diabetes technology into investigator's clinical practice to sustain tight glucose control 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 Control) translatable to Pediatric Diabetes clinics in the United States that reduces HbA1c and T1D burden and improves patient well-being.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
T1D Patients
Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring
Behavioral: 4T Education and Care
CGM data will be used to create customized weekly feedback to the participant/family by secure MyChart message.




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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.


  2. 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


  3. 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


  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

    1. Not a Problem
    2. A Slight Problem
    3. A Moderate Problem
    4. Somewhat Serious Problem
    5. A Serious Problem
    6. A Very Serious Problem

  5. 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

    1. Not a Problem
    2. A Slight Problem
    3. A Moderate Problem
    4. Somewhat Serious Problem
    5. A Serious Problem
    6. A Very Serious Problem

  6. 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


  7. 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


  8. 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


  9. 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.


  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(Inclusion criteria includes all youth with new onset T1D seen in the Stanford/Lucile Packard Children's Hospital ages 1-21 years of age.

(NOTE: Investigators 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 Dexcom app and Apple HealthKit integration and transmission of GluVue remote data monitoring [Dr Prahalad's LPCH Auxiliary Fund grant (in addition to the R18) has resources to support iPod Touch purchase for participants who do not have these.]

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336969


Locations
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United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: David M Maahs, MD, PhD Lucile Packard Children's Hospital; Stanford University, School of Medicine
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Responsible Party: David Maahs, Chief of Pediatric Endocrinology, Stanford University
ClinicalTrials.gov Identifier: NCT04336969    
Other Study ID Numbers: 52812
1R18DK122422-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases