Type 1 DiabetesIITTNCT04589689

Insul-In This Together Program for Adolescents With Type 1 Diabetes and Their Parents

A study testing Insul-In This Together in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and older
Conditions the study is for: Type 1 Diabetes
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: 366 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2020to 6 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months
Teen subject is age 12-19 years at time of screening (no age limit for parent participants)
Participation of at least one cohabitating parent/caregiver.

Who cannot join

Subject lacks access to a smartphone or Wi-Fi via computer
Subject has restricted or no English proficiency
Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents

The "Insul-In This Together" intervention is designed for teens with Type 1 Diabetes and their parents. This study seeks to evaluate an evidence-based family intervention for teens with type 1 diabetes and their parents to offset the psychosocial and diabetes self-management risks. This information will provide a more in-depth understanding of family-based program efficacy for teens with adolescents and provide more judicious and streamlined intervention options to be offered in diabetes clinics in the future.

Read the detailed description

This study will collect survey and biomedical data to assess this program in a randomized controlled trial with 165 families (including an adolescent and parent/caregiver) will be enrolled, complete surveys, provide biomedical data via continuous glucose monitors and receive a 6-week psychosocial intervention. The results of this study will inform future intervention redesign to provide more judicious interventions to be disseminated across diabetes care.This study will evaluate the relative efficacy of each of the individual intervention components and also identify the mechanisms of actions (mediators) that are most impacted by these types of interventions as well as most linked to long-term outcomes for adolescents.

Conditions: Type 1 Diabetes
Being tested: Insul-In This Together
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
Session 1: Introduction to Parental Monitoring Session 2: Advanced Parental Monitoring Session 3: Introduction to Parental Involvement Session 4: Advanced Parental Involvement Session 5: Introduction to Parent-Teen Conflict Management Session 6: Advanced Parent-Teen Conflict Management

Study groups in NCT04589689
Study group	Role	What they receive
Intervention Group	Experimental	The intervention group will participated in the The Insul-In This Together intervention, which consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication. Sessions include structured education, discussions, and skill-building activities related to parental involvement, parental monitoring, and parent-adolescent conflict. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week follow-ups (after every 2 sessions for the intervention group and later the control group). Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up. Receives: Behavioral: Insul-In This Together
Waitlisted Control Group	Experimental	The waitlisted control group will receive the same intervention as the intervention group, but at the 6-month follow-up mark. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week from baseline. Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up. Receives: Behavioral: Insul-In This Together

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more.
Measured: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)
Adolescent Quality of Life
Self-report via Type 1 Diabetes and Life (T1DAL) surveys for adolescents to measure the adolescent's quality of life. Possible score range is 0-100 and the higher scores indicated better quality of life. Adolescent quality of life was measured for adolescents only (not parents).
Measured: Baseline, 3-month follow-up, and 6-month follow-up.

Secondary outcomes (6)

Adolescent Depression
Surveys of self-report via Children's Depression Inventory - short version (CDI:S80), a 10 scale item, will be used to assess adolescent depression. Possible total score range is 0-20 with higher scores indicated more severe depressive symptoms. Item response options included 0 = Not at all, 1 = Somewhat, and 2 = A lot. Total score was the sum of all item scores.
Measured: Baseline, 3-month follow-up, and 6-month follow-up.
Parent Depression
Surveys of self-report via the Patient Health Questionnaire (PHQ-8) - 8 item scale to assess depression among parents. Response options for each item included 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. Items were summed into a total score. The possible total score range is 0-24 and higher scores indicate more depressive symptoms.
Measured: Baseline, 3-month follow-up, and 6-month follow-up.
Adolescent Diabetes Distress
Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 14 items that were summed to create a total score with a possible total score range of 14-84. Item response options range from 1 (not a problem) to 6 (serious problem). Higher scores indicate more diabetes distress.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Parent Diabetes Distress
Measured by the Problem Areas In Diabetes (PAID) survey of diabetes distress, which includes 15 items that were summed into a total score with a possible total score range of 15-90. Higher scores indicate more diabetes distress. Response options ranged from 1 (not a problem) to 6 (serious problem).
Measured: Baseline, 3-month follow-up, and 6-month follow-up.
Parenting Stress
Surveys of self-report on parenting stress via The Parenting Stress Scale. Includes 18 items that were summed into a total score with a possible total score range from 18-90. Higher scores indicate more parenting stress. Item responses included 1 = strongly agree, 2 = agree, 3 = not sure, 4 = disagree, and 5 = strongly disagree.
Measured: Baseline, 3-month follow-up, and 6-month follow-up
Hemoglobin A1c (HbA1c)
Medical record data on glycated hemoglobin in blood reported as National Glycohemoglobin Standardization Program (NGSP) percentage. The clinical recommendation for pediatrics is below 7.5%.
Measured: Baseline and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 20206 May 2024

First posted19 Oct 2020
Study start18 Dec 2020
Primary completion6 May 2024
Study completion6 May 2024

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.
Other trials for Type 1 DiabetesStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).
Masking: None (open label)
Enrolment: 366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04589689
Sponsor's protocol ID: 58372
Other IDs: 1K23DK121771-01A1
Acronym: IITT
Status last verified: Apr 2025
First submitted: 1 Oct 2020
Last updated: 15 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Insul-In This Together Program: Optimizing Family-based Interventions for Adolescents With Type 1 Diabetes and Their Parents
ClinicalTrials.gov ID: NCT04589689
Acronym / sponsor ID: IITT / 58372
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 366 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 18 Dec 2020 (actual)
Primary completion: 6 May 2024 (actual)
Study completion: 6 May 2024 (actual)
First posted: 19 Oct 2020 (actual)
Results: Posted 15 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomization to either the intervention group (receives program immediately) or a waitlisted control condition (receives the intervention 6 months later).

Arm	Type	Receives
Intervention Group	Experimental	Behavioral: Insul-In This TogetherThe intervention group will participated in the The Insul-In This Together intervention, which consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication. Sessions include structured education, discussions, and skill-building activities related to parental involvement, parental monitoring, and parent-adolescent conflict. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week follow-ups (after every 2 sessions for the intervention group and later the control group). Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
Waitlisted Control Group	Experimental	Behavioral: Insul-In This TogetherThe waitlisted control group will receive the same intervention as the intervention group, but at the 6-month follow-up mark. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week from baseline. Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Teen subject has a type 1 diabetes (T1D) diagnosis according to ADA criteria for at least 6 months
Teen subject is age 12-19 years at time of screening (no age limit for parent participants)
Participation of at least one cohabitating parent/caregiver.

Key exclusion criteria (3 listed)

Subject lacks access to a smartphone or Wi-Fi via computer
Subject has restricted or no English proficiency
Subject has a pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study

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 TogetherSession 1: Introduction to Parental Monitoring Session 2: Advanced Parental Monitoring Session 3: Introduction to Parental Involvement Session 4: Advanced Parental Involvement Session 5: Introduction to Parent-Teen Conflict Management Session 6: Advanced Parent-Teen Conflict Management	Behavioural	Intervention Group, Waitlisted Control Group

Primary outcome

Glucose Levels Percent Time in Target Range Based on Glucose Monitoring
Time frame: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)
Adolescent glucose levels percent time in target range (70-180 mg/dL) based on glucose monitoring to measure glycemic control. The clinical recommendation is a percent time-in-range of 70% or more.
Adolescent Quality of Life
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Self-report via Type 1 Diabetes and Life (T1DAL) surveys for adolescents to measure the adolescent's quality of life. Possible score range is 0-100 and the higher scores indicated better quality of life. Adolescent quality of life was measured for adolescents only (not parents).

6 secondary outcomes

Adolescent Depression
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Parent Depression
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Adolescent Diabetes Distress
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Parent Diabetes Distress
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Parenting Stress
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
Hemoglobin A1c (HbA1c)
Time frame: Baseline and 6-month follow-up

Results and safety

Results posted to the registry on 15 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group - Adolescents	79	68
Intervention Group - Parents	79	68
Waitlisted Control Group - Adolescents	78	61
Waitlisted Control Group - Parents	78	61

Primary outcome: Glucose Levels Percent Time in Target Range Based on Glucose Monitoring

Time frame: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date). Mean (Standard Deviation). Unit: percentage of time-in-range

Measure	Intervention Group n = 79	Waitlisted Control Group n = 78
Baseline	61.185 (18.42)	64.542 (17.74)
3 months	62.223 (18.57)	64.571 (18.21)
6 months	61.680 (18.91)	65.908 (17.82)

Intervention Group vs Waitlisted Control Group: p = 0.777, t-test, 2 sided
Intervention Group vs Waitlisted Control Group: p = 0.247, t-test, 2 sided

Population analysed: Enrolled adolescents; data for this outcome were not collected from parents

Primary outcome: Adolescent Quality of Life

Time frame: Baseline, 3-month follow-up, and 6-month follow-up.. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Group n = 79	Waitlisted Control Group n = 78
Baseline	67.902 (13.92)	64.633 (15.38)
3-month	67.965 (14.47)	63.675 (16.39)
6-month	69.523 (14.63)	65.511 (16.16)

Intervention Group vs Waitlisted Control Group: p = 0.160, t-test, 2 sided
Intervention Group vs Waitlisted Control Group: p = 0.275, t-test, 2 sided

Population analysed: Enrolled adolescents; data for this outcome were not collected from parents

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group - Adolescents	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Intervention Group - Parents	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Waitlisted Control Group: Control - Adolescents	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Waitlisted Control Group: Control - Parents	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Waitlisted Control Group: Intervention - Adolescents	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Waitlisted Control Group: Intervention - Parents	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

Korey K Hood, 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?

A study testing Insul-In This Together in people with Type 1 Diabetes, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 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?

Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glucose Levels Percent Time in Target Range Based on Glucose Monitoring (time frame: Average percent time in range based on two weeks of glucose monitoring data at baseline, 3-month, and 6-month follow-up (plus or minus 2 weeks around target data collection date)). 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?

On the ClinicalTrials.gov record for NCT04589689.

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 15 May 2025.