Diabetes Type 1IITTNCT07856836
Insul-In This Together: Leveraging Family Support and Diabetes Technology for Adolescents Living With Type 1 Diabetes
A study testing Insul-In This Together in people with Diabetes Type 1, run by Stanford University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the "Insul-In This Together" family program works to improve outcomes for adolescents living with type 1 diabetes. It will also learn about how the program influences diabetes-related factors, including parenting. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- Insul-In This Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2028to Jun 2032
- Phase
- Interventional
- 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For adolescent participants: ages 12-17, diagnosed with type 1 diabetes for at least 6 months, US resident, English proficiency, and resides with the participating parent/caregiver.
- For parent participants: residing with eligible and participating adolescent, US resident, and English proficiency.
Who cannot join
- Severe or pervasive physical or mental health condition that would limit participation in data collection or the intervention (e.g., pervasive developmental delays).
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
Stanford University
Palo Alto, California, 94305
Jessie J Wong, PhD, 6507361517, wongjj@stanford.edu
Jessie J Wong, PhD
About this study
The goal of this clinical trial is to learn if the "Insul-In This Together" family program works to improve outcomes for adolescents living with type 1 diabetes. It will also learn about how the program influences diabetes-related factors, including parenting. The main questions it aims to answer are:
Does this program improve glycemic (blood glucose) outcomes? Does this program improve adolescent quality of life related to diabetes? Researchers will offer the program to all participating families, with one group receiving the program right after enrollment and another group receiving the program 6 months later.
Read more
Adolescent and parent participants will:
Attend 8 weekly 30-minute videoconference sessions with an interventionist Complete online surveys, share diabetes device data, and conduct at-home A1c tests 3-5 times over a 12-month period
Read the detailed description
The proposed study is a nationwide randomized controlled trial with 200 adolescents ages 12-17 living with type 1 diabetes for at least six months who are US residents and their parents. Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up). The primary outcome endpoint will be 3-month post-baseline, based on prior findings. This cross-over design will support recruitment and retention and offer all participants the opportunity to receive this empirically supported program, while maintaining an experimental comparison group. The revised intervention includes eight 30-minute weekly sessions to be delivered to each parent-adolescent dyad by a trained interventionist. Didactic and interactive content targets parental monitoring, involvement strategies, collaborative problem-solving, and communication across six sessions with two glycemic sessions that focus on glucose monitoring, data interpretation, and strategies to increase/optimize technology use. Data will be gathered via adolescent and parent report, continuous glucose monitoring (CGM) and other device data, and at-home HbA1c test kits. We will assess intervention outcomes, differential intervention responses, and key drivers of change.
- Conditions
- Diabetes Type 1
- Being tested
- Insul-In This Together
- Keywords
- Type 1 Diabetes, Adolescents, Parents, Diabetes Technology
- 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.
Insul-In This TogetherBehavioural
The "Insul-In This Together" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent/caregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Offered the intervention immediately after Baseline data collection Receives: Behavioral: Insul-In This Together |
| Waitlisted Control | Other | Offered the intervention after 6-Month Post-Baseline data collection Receives: Behavioral: Insul-In This Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent diabetes-related quality of life
The Type 1 Diabetes and Life (T1DAL) survey is a 23-item scale with a teen version (ages 12-17) and a young adult version (ages 18-25) that capture quality of life related to living with diabetes (for those who turn 18 during the study).
Measured: From Baseline (post enrollment) to 12-month post-baseline
Percent time-in-range (TIR)
TIR is strongly linked to risk of health complications and offers valuable insights beyond hemoglobin A1c, particularly.13 Percent time spent in target range (70-180mg/dL) will be calculated based on continuous glucose monitoring (CGM) data captured in a 14-day window. At least 10 days of data will be required within the 14-day window to be included in analyses.
Measured: From baseline (post enrollment) to 12-month post-baseline
Secondary outcomes (3)
Hemoglobin A1c
HbA1c results will be gathered based on at-home test kits provided and analyzed by University of Minnesota.
Measured: From baseline (post enrollment) to 12-month post-baseline
Adolescent diabetes distress
The Problem Areas in Diabetes questionnaire (PAID) is a 20-item scale of emotional responses related to diabetes distress among adolescents.
Measured: From baseline (post enrollment) to 12-month post-baseline
Parent diabetes distress
The Parent Diabetes Distress Scale (P-DDS) is a 20-item measure of diabetes related distress among parents of teens with diabetes.
Measured: From Baseline (post enrollment) to 12-month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startJan 2028 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Wong, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856836
- Sponsor's protocol ID
- 88772
- Acronym
- IITT
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary results. Requests will be reviewed by the study team and will require a scientifically sound proposal, institutional approvals as applicable, and a data use agreement that prohibits re-identification or onward sharing. Data sharing will be limited to information that can be provided without compromising participant privacy or confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insul-In This Together: Leveraging Family Support and Diabetes Technology for Adolescents Living With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07856836
- Acronym / sponsor ID
- IITT / 88772
- Conditions
- Diabetes Type 1
- Keywords
- Type 1 Diabetes, Adolescents, Parents, Diabetes Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2028 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 5 Oct 2026 (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 this clinical trial is to learn if the "Insul-In This Together" family program works to improve outcomes for adolescents living with type 1 diabetes. It will also learn about how the program influences diabetes-related factors, including parenting. The main questions it aims to answer are:
Does this program improve glycemic (blood glucose) outcomes? Does this program improve adolescent quality of life related to diabetes? Researchers will offer the program to all participating families, with one group receiving the program right after enrollment and another group receiving the program 6 months later.
Adolescent and parent participants will:
Attend 8 weekly 30-minute videoconference sessions with an interventionist Complete online surveys, share diabetes device data, and conduct at-home A1c tests 3-5 times over a 12-month period
Detailed description
The proposed study is a nationwide randomized controlled trial with 200 adolescents ages 12-17 living with type 1 diabetes for at least six months who are US residents and their parents. Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up). The primary outcome endpoint will be 3-month post-baseline, based on prior findings. This cross-over design will support recruitment and retention and offer all participants the opportunity to receive this empirically supported program, while maintaining an experimental comparison group. The revised intervention includes eight 30-minute weekly sessions to be delivered to each parent-adolescent dyad by a trained interventionist. Didactic and interactive content targets parental monitoring, involvement strategies, collaborative problem-solving, and communication across six sessions with two glycemic sessions that focus on glucose monitoring, data interpretation, and strategies to increase/optimize technology use. Data will be gathered via adolescent and parent report, continuous glucose monitoring (CGM) and other device data, and at-home HbA1c test kits. We will assess intervention outcomes, differential intervention responses, and key drivers of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Insul-In This TogetherOffered the intervention immediately after Baseline data collection |
| Waitlisted Control | Other | Behavioral: Insul-In This TogetherOffered the intervention after 6-Month Post-Baseline data collection |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- For adolescent participants: ages 12-17, diagnosed with type 1 diabetes for at least 6 months, US resident, English proficiency, and resides with the participating parent/caregiver.
- For parent participants: residing with eligible and participating adolescent, US resident, and English proficiency.
Key exclusion criteria (1 listed)
- Severe or pervasive physical or mental health condition that would limit participation in data collection or the intervention (e.g., pervasive developmental delays).
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 |
|---|---|---|
| Insul-In This TogetherThe "Insul-In This Together" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent/caregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use. | Behavioural | Intervention, Waitlisted Control |
Primary outcome
Adolescent diabetes-related quality of life
Time frame: From Baseline (post enrollment) to 12-month post-baseline
The Type 1 Diabetes and Life (T1DAL) survey is a 23-item scale with a teen version (ages 12-17) and a young adult version (ages 18-25) that capture quality of life related to living with diabetes (for those who turn 18 during the study).
Percent time-in-range (TIR)
Time frame: From baseline (post enrollment) to 12-month post-baseline
TIR is strongly linked to risk of health complications and offers valuable insights beyond hemoglobin A1c, particularly.13 Percent time spent in target range (70-180mg/dL) will be calculated based on continuous glucose monitoring (CGM) data captured in a 14-day window. At least 10 days of data will be required within the 14-day window to be included in analyses.
3 secondary outcomes
Hemoglobin A1c
Time frame: From baseline (post enrollment) to 12-month post-baseline
Adolescent diabetes distress
Time frame: From baseline (post enrollment) to 12-month post-baseline
Parent diabetes distress
Time frame: From Baseline (post enrollment) to 12-month post-baseline
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 5 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary results. Requests will be reviewed by the study team and will require a scientifically sound proposal, institutional approvals as applicable, and a data use agreement that prohibits re-identification or onward sharing. Data sharing will be limited to information that can be provided without compromising participant privacy or confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insul-In This Together in people with Diabetes Type 1, 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?
Contact Jessie J Wong, PhD (6507361517, wongjj@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent diabetes-related quality of life (time frame: From Baseline (post enrollment) to 12-month post-baseline). 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 5 Oct 2026.