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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK122422-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1D Patients | Other | Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
| 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 |
| 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. |
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.)
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:
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| Name | Affiliation | Role |
|---|---|---|
| David M Maahs, MD, PhD | Lucile Packard Children's Hospital; Stanford University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franziska Katherine Bishop | Steamboat Springs | Colorado | 80487 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38702523 | Result | Prahalad P, Scheinker D, Desai M, Ding VY, Bishop FK, Lee MY, Ferstad J, Zaharieva DP, Addala A, Johari R, Hood K, Maahs DM. Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes. Nat Med. 2024 Jul;30(7):2067-2075. doi: 10.1038/s41591-024-02975-y. Epub 2024 May 3. | |
| 40590663 | Result | Zaharieva DP, Ritter V, Bishop FK, Desai M, Addala A, Prahalad P, Riddell MC, Maahs DM; 4T Study Group. Physical Activity Is Associated With Improved Glycemic Outcomes in Newly Diagnosed Youth With Type 1 Diabetes: 4T Exercise Program. Diabetes Care. 2025 Oct 1;48(10):1752-1760. doi: 10.2337/dc25-0765. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2026 |
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| 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
| 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
| 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 |
| 4-12 month trajectory in study 2 |
| 39604317 | Result | Addala A, Ritter V, Schneider-Utaka AK, Alamarie SA, Pang E, Balistreri I, Shaw B, Bishop FK, Zaharieva DP, Prahalad P, Desai M, Maahs DM, Hood KK; 4T Team. Psychosocial outcomes in a diverse sample of youth and their families who initiated continuous glucose monitoring within the first year of type 1 diabetes diagnosis. Diabetes Obes Metab. 2025 Feb;27(2):933-943. doi: 10.1111/dom.16093. Epub 2024 Nov 27. |
| 38320487 | Derived | Ferstad JO, Prahalad P, Maahs DM, Zaharieva DP, Fox E, Desai M, Johari R, Scheinker D. Smart Start - Designing Powerful Clinical Trials Using Pilot Study Data. NEJM Evid. 2024 Feb;3(2):EVIDoa2300164. doi: 10.1056/EVIDoa2300164. Epub 2024 Jan 22. |
| 37955644 | Derived | Zaharieva DP, Ding VY, Addala A, Prahalad P, Bishop F, Hood KK, Desai M, Wilson DM, Buckingham BA, Maahs DM. Diabetic Ketoacidosis at Diagnosis in Youth with Type 1 Diabetes Is Associated with a Higher Hemoglobin A1c Even with Intensive Insulin Management. Diabetes Technol Ther. 2024 Mar;26(3):176-183. doi: 10.1089/dia.2023.0405. |
| 37074715 | Derived | Addala A, Ding V, Zaharieva DP, Bishop FK, Adams AS, King AC, Johari R, Scheinker D, Hood KK, Desai M, Maahs DM, Prahalad P; Teamwork, Targets, Technology, and Tight Control (4T) Study Group. Disparities in Hemoglobin A1c Levels in the First Year After Diagnosis Among Youths With Type 1 Diabetes Offered Continuous Glucose Monitoring. JAMA Netw Open. 2023 Apr 3;6(4):e238881. doi: 10.1001/jamanetworkopen.2023.8881. |