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

NCT04336969 | Completed

• 2 other identifiers: 528121R18DK122422-01A1
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in CGM Benefits and Burden Scale

  Baseline, 3, 6, 9 and 12 months

• Change Diabetes Distress Scale

  Baseline, 3, 6, 9 and 12 months

• Change in Diabetes Technology Attitude Scale

  Baseline, 3, 6, 9 and 12 months

• Change in Parental Diabetes Distress Scale

  Baseline, 3, 6, 9 and 12 months

• Change in Promise Global Health Scale

  Baseline, 3, 6, 9 and 12 months

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

  4-12 month trajectory in study 2

Study Arms (1)

T1D Patients

OTHER

Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring

Behavioral: 4T Education and Care

Interventions

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.

T1D Patients

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Stanford University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Franziska Katherine Bishop

Steamboat Springs, Colorado, 80487, United States

Location

Related Publications (6)

• 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.

  PMID: 38702523 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.

  PMID: 40590663 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.

  PMID: 39604317 RESULT

• 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.

  PMID: 38320487 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.

  PMID: 37955644 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.

  PMID: 37074715 DERIVED

Study Officials

• David M Maahs, MD, PhD

  Lucile Packard Children's Hospital; Stanford University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Endocrinology

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: June 18, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 3, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)