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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type1diabetes
• Intervention / Treatment: Behavioral: 4T Education and Care

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.

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 (160+) receiving the 4T new onset intervention designed to decrease the rise in HbA1c seen from 4 to 12 months but following a tapered remote monitoring schedule will be compared to internal (4T Pilot and 4T Study 1) and external contemporaneous controls (CMH and DPV).

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Steamboat Springs, Colorado, United States, 80487
      • Franziska Katherine Bishop

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Dexcom app and Apple HealthKit integration and transmission to the hospital server-based remote monitoring system and EHR.

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in rise of HbA1c	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.	Baseline, 6 months and 12 months post-diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CGM Benefits and Burden Scale	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	Baseline, 3, 6, 9 and 12 months
Change Diabetes Distress Scale	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	Baseline, 3, 6, 9 and 12 months
Change in Diabetes Technology Attitude Scale	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	Baseline, 3, 6, 9 and 12 months
Change in Parental Diabetes Distress Scale	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	Baseline, 3, 6, 9 and 12 months
Change in Promise Global Health Scale	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	Baseline, 3, 6, 9 and 12 months
Change in Physical Activity, Youth Physical Activity Questionnaire (Y-PAQ)	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.	Baseline, 3, 6 and 9 months
Change in Physical Activity, International Physical Activity Questionnaire (IPAQ)	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.	Baseline, 3, 6 and 9 months
Change in participant Hypoglycemic Fear Scale	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	Baseline, 3, 6 and 9 months
Change in parent Hypoglycemic Fear Scale	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	Baseline, 3, 6 and 9 months
Change in Self-Efficacy for Exercise Scale	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.	Baseline, 3, 6, and 9 months
Change in education exposure to safe exercise strategies	Percentage of participants attending at least one telehealth session and a measure of education exposure to safe exercise strategies	Baseline, 3, 6, and 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	4-12 month trajectory in study 2

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: David M Maahs, MD, PhD, Lucile Packard Children's Hospital; Stanford University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 52812; 1R18DK122422-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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