Type1diabetesNCT04336969
Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
A study testing 4T Education and Care in people with Type1diabetes, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- 4T Education and Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2020to 1 Jul 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Medicine Children's Health
Palo Alto, California, 94304
About this study
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.
Read the detailed description
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).
- Conditions
- Type1diabetes
- Being tested
- 4T Education and Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4T Education and CareBehavioural
CGM data will be used to create customized weekly or monthly feedback to the participant/family by secure MyChart message.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: T1D Patients | Other | Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring, and 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. Receives: Behavioral: 4T Education and Care |
| Cohort 2: T1D Patients | Other | Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring, and receive the 4T new onset intervention, designed to decrease the rise in HbA1c seen from 4 to 12 months, following a tapered (from weekly to monthly) remote monitoring schedule. Receives: Behavioral: 4T Education and Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rise of HbA1c
HbA1c (a measure of blood sugar levels over the previous 3 months) change from 4 to 12 months after diagnosis as a measurement of the effect of the 4T program. Collected through a blood sample.
Cohort 1: Primary outcome was HbA1c change from 4 to 12 months after diagnosis
Cohort 2 (stepped down cadence - weekly to monthly RPM): Primary outcome was HbA1c change from 4 to 12 months after diagnosis compared to weekly RPM
Historical Cohort: Outcomes were compared with a retrospective historical cohort derived from medical records collected prior to study initiation. The historical cohort was not enrolled in this study.
Measured: 4 to 12 months post-diagnosis
Secondary outcomes (12)
Change in Diabetes Distress Scale Parent
Parent Diabetes Distress Scale (Parent-DDS):
The Parent-DDS is a 20-item questionnaire assessing diabetes-related distress experienced by parents of adolescents with type 1 diabetes. It includes four subscales: Personal Distress, Teen Management Distress, Parent/Teen Relationship Distress, and Healthcare Team Distress.
Each item is rated on a 6-point Likert scale ranging from 1 (Not a problem) to 6 (A very serious problem). Total and subscale scores are calculated as the mean of the completed item responses (sum of the item responses divided by the number of completed items), yielding possible scores ranging from 1.0 to 6.0 for both the total score and each subscale. Higher scores indicate greater diabetes-related parental distress (worse outcome). Mean item scores of 1.0-1.9 indicate "little or no distress", 2.0-2.9 indicate "moderate distress", and ≥3.0 indicate "high distress". Moderate or high distress may warrant clinical attention depending on the clinical context.
Measured: Baseline, 3, 6, 9 and 12 months
Change Diabetes Distress Scale Youth
Diabetes Distress Scale-Youth (DDS-2) Youth completed the DDS-225 survey that evaluates if youth have been "feeling overwhelmed by demands of living with diabetes" or "failing with my diabetes routine" on a six-point Likert scale ("1: Not a problem" to "A very serious problem") in the last month. The response from each question was summed to create a score from 2 to 12, where higher scores are indicative of more symptoms of diabetes distress. The DDS-2 was selected for youth as it is an established screening measure for additional evaluation and to minimize survey burden.
Measured: Baseline, 3, 6, 9 and 12 months
Change in CGM Benefits Scale
This tool measures the benefits and burden of Continuous Glucose Monitor (CGM) device use, and is reported by youth participants who were 11 and older.
Continuous Glucose Monitoring Benefits Scale (BenCGM):
The BenCGM is an 8-item questionnaire assessing perceived benefits of continuous glucose monitoring (CGM).
Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Item responses are summed to calculate a total score ranging from 8 to 40. Higher scores indicate greater perceived benefits of CGM (better outcome).
Measured: Baseline, 3, 6, 9 and 12 months
Change in CGM Barriers
This tool measures the burden of Continuous Glucose Monitor (CGM) device use, and is reported by youth participants who were 11 and older.
Continuous Glucose Monitoring Burden Scale (BurCGM):
The BurCGM is an 8-item questionnaire assessing perceived burdens of continuous glucose monitoring (CGM).
Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Item responses are summed to calculate a total score ranging from 8 to 40. Higher scores indicate greater perceived burdens of CGM (worse outcome).
Measured: 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.
Diabetes Technology Attitude Scale:
The Diabetes Technology Attitude Scale is a 5-item participant-reported questionnaire assessing attitudes toward diabetes-specific technology.
Each item is rated on a 5-point Likert scale to indicate agreement with the statement, ranging from 1 (Strongly disagree) to 5 (Strongly agree). Item responses are summed to calculate a total score ranging from 5 to 25. Higher scores indicate more positive attitudes toward diabetes technology (better outcome).
Measured: Baseline, 3, 6, 9 and 12 months
Change in PROMIS Global Health Scale
This measure is widely used to capture general and overall health and is reported by participants (youth).
PROMIS Pediatric Global Health (PGH-7):
The PROMIS Pediatric Global Health (PGH-7) is a 7-item participant-reported questionnaire that assesses youths' perceptions of their overall health, quality of life, physical health, and mental health.
Each item is rated on a 5-point Likert scale ranging from 1 (Poor) to 5 (Excellent). Item responses are summed to calculate a total score ranging from 7 to 35. Higher scores indicate better overall pediatric global health (better outcome).
Measured: 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.
Measured: 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 (youth).
International Physical Activity Questionnaire (IPAQ): The IPAQ assesses self-reported physical activity during the previous 7 days, including vigorous-intensity activity, moderate-intensity activity, walking, and sitting. Total physical activity is reported as metabolic equivalent of task minutes per week (MET-minutes/week) and is calculated by weighting the reported duration and frequency of walking, moderate-intensity activity, and vigorous-intensity activity by their corresponding MET values (3.3, 4.0, and 8.0 METs, respectively) and summing these values. Sitting time is assessed separately and is not included in the total MET-minutes/week calculation. Higher MET-minutes/week indicate greater physical activity.
Measured: Baseline, 6 and 12 months
Change in Participant Hypoglycemic Fear Scale Youth
The Hypoglycemic Fear Survey in Youth (HFS-II) is a 25-item participant-reported questionnaire assessing fear of hypoglycemia in youth with type 1 diabetes. It includes a 10-item Behavior subscale and a 15-item Worry subscale. Each question was scored on a 5-point Likert scale ranging from 0 to 4:
0 = Never
- = Rarely
- = Sometimes
- = Often
- = Almost Always
For each participant, item ratings are summed to calculate the Behavior score (range: 0-40) and Worry score (range: 0-60). The Total score is calculated by summing the Behavior and Worry scores (range: 0-100). Higher scores on the Youth Behavior subscale indicate greater avoidance behaviors (worse outcome). Higher scores on the Youth Worry subscale indicate greater worry regarding hypoglycemia (worse outcome). Higher total scores indicate greater overall fear of hypoglycemia (worse outcome). The table reports the mean and standard deviation of participants' summed scores at baseline, 6 months, and 12 months.
Measured: Baseline, 6 and 12 months
Change in Hypoglycemic Fear Scale Parent
The Hypoglycemic Fear Survey-Parent (HFS-P) is a 26-item parent-reported questionnaire assessing fear of hypoglycemia for their child with type 1 diabetes. It includes a 11-item Behavior subscale and a 15-item Worry subscale. Each question was scored on a 5-point Likert scale ranging from 0 to 4:
0 = Never
- = Rarely
- = Sometimes
- = Often
- = Almost Always
For each participant, item ratings are summed to calculate the Behavior score (range: 0-44) and Worry score (range: 0-60). The Total score is calculated by summing the Behavior and Worry scores (range: 0-104). Higher scores on the Parent Behavior subscale indicate greater avoidance/preventative behaviors (worse outcome). Higher scores on the Parent Worry subscale indicate greater worry regarding hypoglycemia (worse outcome). Higher total scores indicate greater overall fear of hypoglycemia (worse outcome). Table reports the mean and standard deviation of participants' summed scores at baseline, 6 months, and 12 months.
Measured: Baseline, 6 and 12 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.
Measured: Baseline, 3, 6, and 9 months
Education Exposure to Safe Exercise Strategies
The number of participants attending at least one telehealth exercise education session.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start18 Jun 2020
- Primary completion1 Jul 2025
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, David Maahs, Stanford University
- Investigators
- David M Maahs, MD, PhD, Principal investigator, Lucile Packard Children's Hospital; Stanford University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336969
- Sponsor's protocol ID
- 52812
- Other IDs
- 1R18DK122422-01A1
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2020
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38702523Zaharieva 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.
PubMed 40590663Addala 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.
PubMed 39604317Ferstad 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.
PubMed 38320487Zaharieva 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.
PubMed 37955644Addala 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.
PubMed 37074715