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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
316
CGM data will be used to create customized weekly or monthly feedback to the participant/family by secure MyChart message.
Franziska Katherine Bishop
Steamboat Springs, Colorado, United States
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.
Time frame: Baseline, 6 months and 12 months post-diagnosis
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
Time frame: 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 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
Time frame: 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
Time frame: 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 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
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Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, 3, 6, and 9 months