Type1diabetesNCT06314048
4T Sustainability Program
An observational study of Type1diabetes, run by Stanford University at 1 site in United States.
Trial summary
The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial 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?
- CGM and RPM
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients seen at Stanford Children's Diabetes Clinic diagnosed with Type 1 Diabetes.
Who may be able to join
- 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. The program will also be offered to pediatric patients with existing T1D who wear a CGM or want to start a CGM and receive RPM. 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 with a 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 wear a CGM that will connect to the RPM-care model
- Age: six months to < 21 years of age
- Patient or guardian must own and operate a compatible smart device/phone to send data from the CGM into the HIPAA-compliant RPM-care model for data analysis and review by a care team member.
- Dr. Maahs and Pediatric Endocrinology have philanthropic funds available to purchase compatible smart devices for participants who do not have a compatible smart device/phone.
Who cannot join
- Diabetes diagnosis other than T1D
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D: 4T Sustainability Program.
The goal of the 4T program is to implement proven methods and emerging diabetes technology into 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 expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities.
Read the detailed description
The investigators propose a multi-disciplinary diabetes team approach to utilize existing and emerging diabetes technologies and education strategies to implement scalable diabetes care with the goal of maintaining tight control for newly diagnosed Pediatric T1D patients. Successful T1D care is more than glucose control; the 4T program will closely monitor psychosocial and patient-reported outcomes (PROs) through the established psychosocial screening and treatment program. The 4T program will utilize automated approaches to analyze glucose profiles developed in conjunction with the Stanford SURF (Systems Utilization Research For Stanford Medicine) team. The 4T program will tailor intervention to those patients most in need of team support employing a broad range of behavioral and technology supports, strengths of the Stanford Pediatric Diabetes program. The 4T program approach more precisely adapts care to patient needs and optimizes glucose and psychosocial outcomes.
Therefore, the investigators propose to expand the diabetes team approach (Teamwork, Targets, and Technology for Tight Control: 4T), which utilizes existing diabetes technologies and education strategies to implement and standardize goal-oriented diabetes care for newly diagnosed pediatric T1D patients, to a standard of care program at Stanford pediatric diabetes clinics. The Stanford diabetes team has revised the diabetes education approach to set clear and tighter targets at new-onset through the early phase of T1D and to be aggressive with the intensification of control as insulin needs and care demands increase. The 4T Sustainability program will further standardize T1D team care while allowing for personalization based on patient/family needs with the goal of optimizing glucose and psychosocial outcomes. (NOTE: the current protocol [IRB #52812] focuses on early initiation of CGM as the key technology for glucose monitoring. The 4T program is designed to be flexible to incorporate emerging technologies as they become available for patient care. For example, automated insulin delivery systems will be supported as part of the program). To make the 4T Sustainability Program a true standard of care program, remote patient monitoring (RPM) of the CGM data and CDCES-tailored patient contacts will be billed using RPM billing codes. These RPM billing codes have received hospital compliance approval, and billing workflows will be available in LPCH EPIC.
Personalized Goals and Automated Identification for Need for Insulin Changes in New Onsets: Data collected by continuous glucose monitoring (CGM) can improve the quality of patient care; facilitate the use of telemedicine to reduce costs and improve convenience; and improve the understanding of how daily behaviors shape long-term outcomes.
Modern Electronic Health Records (EHRs) can potentially be used to reduce the workload necessary to care for patients; reduce error rates by automating alerts; and facilitate continuous evaluation and improvement of provider adherence to best-practices. To be practical and scalable, these systems must provide actionable information and require relatively few inputs. The investigators have developed stand-alone tools that analyze CGM time series data to set personalized care goals and to determine when glucose values increase, or insulin dose adjustments and other care adaptations are required. To allow Stanford and the broader community to realize the full potential of such tools, the investigators will implement and refine their use in our clinics:
- Implement and refine analytical methods and software tools to interpret and improve the quality of time-series CGM data, set personalized goals, and generate automated notifications for care providers.
- A data-driven intervention to improve long-term outcomes for early onset patients including a hospital- server-based monitoring system to evaluate the intervention. [Note: identification is the goal of the system and medical advice will be solely given by trained healthcare professionals.]
- Conditions
- Type1diabetes
- Being tested
- CGM and RPM
- Keywords
- Pediatric, Type 1 Diabetes, Continuous Glucose Monitor, Remote Patient Monitoring, Patient Reported Outcomes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM and RPMOther
- Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care - CGM and RPM | 1. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis. Receives: Other: CGM and RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c trajectory observed 4-12 months post-diagnosis
Implement 4T program as standard of care, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.To address Aim 1, the investigators will use generalized linear mixed effects regression techniques that allows for two piecewise linear slopes of HbA1c levels to be estimated from diagnosis to 4 months and from 4 to 12 months post-diagnosis to determine the effect of the 4T diabetes intervention on changes in HbA1c between 4- and 12-months post-diagnosis and compare observed increases to those in our internal and external contemporaneous controls via separate models. Each mixed effects model will include a subject-specific random effect to account for the correlation of HbA1c within a person over time, and these models will be adjusted for sex, age, ethnicity, and insurance type at diagnosis.
Measured: 4-12 months post TID diagnosis
Diabetes distress measured at baseline and 12 months post-diagnosis.
The investigators will utilize generalized linear mixed effects models to address Aim 2. More specifically, the investigators will regress diabetes distress index on use of CGM. Such a model will include a subject-specific random effect and an indicator of whether the patient utilized CGM technologies.
Assuming the ratio of using CGM technology is 0.6 and SD of diabetes distress score is 3, we have 90% power to detect a two-unit reduction on mean diabetes distress score.
Measured: baseline and 12 months post Type 1 Diabetes diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start30 May 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Maahs, Stanford University
- Investigators
- David M Maahs, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314048
- Sponsor's protocol ID
- 74212
- Status last verified
- May 2025
- First submitted
- 15 Feb 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D: 4T Sustainability Program.
- ClinicalTrials.gov ID
- NCT06314048
- Acronym / sponsor ID
- 74212
- Conditions
- Type1diabetes
- Keywords
- Pediatric, Type 1 Diabetes, Continuous Glucose Monitor, Remote Patient Monitoring, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the 4T program is to implement proven methods and emerging diabetes technology into 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 expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities.
Detailed description
The investigators propose a multi-disciplinary diabetes team approach to utilize existing and emerging diabetes technologies and education strategies to implement scalable diabetes care with the goal of maintaining tight control for newly diagnosed Pediatric T1D patients. Successful T1D care is more than glucose control; the 4T program will closely monitor psychosocial and patient-reported outcomes (PROs) through the established psychosocial screening and treatment program. The 4T program will utilize automated approaches to analyze glucose profiles developed in conjunction with the Stanford SURF (Systems Utilization Research For Stanford Medicine) team. The 4T program will tailor intervention to those patients most in need of team support employing a broad range of behavioral and technology supports, strengths of the Stanford Pediatric Diabetes program. The 4T program approach more precisely adapts care to patient needs and optimizes glucose and psychosocial outcomes.
Therefore, the investigators propose to expand the diabetes team approach (Teamwork, Targets, and Technology for Tight Control: 4T), which utilizes existing diabetes technologies and education strategies to implement and standardize goal-oriented diabetes care for newly diagnosed pediatric T1D patients, to a standard of care program at Stanford pediatric diabetes clinics. The Stanford diabetes team has revised the diabetes education approach to set clear and tighter targets at new-onset through the early phase of T1D and to be aggressive with the intensification of control as insulin needs and care demands increase. The 4T Sustainability program will further standardize T1D team care while allowing for personalization based on patient/family needs with the goal of optimizing glucose and psychosocial outcomes. (NOTE: the current protocol [IRB #52812] focuses on early initiation of CGM as the key technology for glucose monitoring. The 4T program is designed to be flexible to incorporate emerging technologies as they become available for patient care. For example, automated insulin delivery systems will be supported as part of the program). To make the 4T Sustainability Program a true standard of care program, remote patient monitoring (RPM) of the CGM data and CDCES-tailored patient contacts will be billed using RPM billing codes. These RPM billing codes have received hospital compliance approval, and billing workflows will be available in LPCH EPIC.
Personalized Goals and Automated Identification for Need for Insulin Changes in New Onsets: Data collected by continuous glucose monitoring (CGM) can improve the quality of patient care; facilitate the use of telemedicine to reduce costs and improve convenience; and improve the understanding of how daily behaviors shape long-term outcomes.
Modern Electronic Health Records (EHRs) can potentially be used to reduce the workload necessary to care for patients; reduce error rates by automating alerts; and facilitate continuous evaluation and improvement of provider adherence to best-practices. To be practical and scalable, these systems must provide actionable information and require relatively few inputs. The investigators have developed stand-alone tools that analyze CGM time series data to set personalized care goals and to determine when glucose values increase, or insulin dose adjustments and other care adaptations are required. To allow Stanford and the broader community to realize the full potential of such tools, the investigators will implement and refine their use in our clinics:
- Implement and refine analytical methods and software tools to interpret and improve the quality of time-series CGM data, set personalized goals, and generate automated notifications for care providers.
- A data-driven intervention to improve long-term outcomes for early onset patients including a hospital- server-based monitoring system to evaluate the intervention. [Note: identification is the goal of the system and medical advice will be solely given by trained healthcare professionals.]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care - CGM and RPM | – | Other: CGM and RPM1. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients seen at Stanford Children's Diabetes Clinic diagnosed with Type 1 Diabetes.
Key inclusion criteria (7 listed)
- 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. The program will also be offered to pediatric patients with existing T1D who wear a CGM or want to start a CGM and receive RPM. 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 with a 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 wear a CGM that will connect to the RPM-care model
- Age: six months to < 21 years of age
Key exclusion criteria (4 listed)
- Diabetes diagnosis other than T1D
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM and RPM1. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis. | Other | Standard of Care - CGM and RPM |
Primary outcome
HbA1c trajectory observed 4-12 months post-diagnosis
Time frame: 4-12 months post TID diagnosis
Implement 4T program as standard of care, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.To address Aim 1, the investigators will use generalized linear mixed effects regression techniques that allows for two piecewise linear slopes of HbA1c levels to be estimated from diagnosis to 4 months and from 4 to 12 months post-diagnosis to determine the effect of the 4T diabetes intervention on changes in HbA1c between 4- and 12-months post-diagnosis and compare observed increases to those in our internal and external contemporaneous controls via separate models. Each mixed effects model will include a subject-specific random effect to account for the correlation of HbA1c within a person over time, and these models will be adjusted for sex, age, ethnicity, and insurance type at diagnosis.
Diabetes distress measured at baseline and 12 months post-diagnosis.
Time frame: baseline and 12 months post Type 1 Diabetes diagnosis
The investigators will utilize generalized linear mixed effects models to address Aim 2. More specifically, the investigators will regress diabetes distress index on use of CGM. Such a model will include a subject-specific random effect and an indicator of whether the patient utilized CGM technologies. Assuming the ratio of using CGM technology is 0.6 and SD of diabetes distress score is 3, we have 90% power to detect a two-unit reduction on mean diabetes distress score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David M Maahs, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c trajectory observed 4-12 months post-diagnosis (time frame: 4-12 months post TID diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.