Type 1 DiabetesNCT05413239
Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
A study testing Psychoeducation to reduce diabetes distress and improve glycemic outcomes in people with Type 1 Diabetes, run by Joslin Diabetes Center at 2 sites in United States.
Trial summary
In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Psychoeducation to reduce diabetes distress and improve glycemic outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2022to 1 Feb 2026
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-25 years
- Diagnosis of type 1 diabetes (according to ADA criteria)
- Type 1 diabetes duration ≥12 months
- A1c 7-13%
- Smartphone or regular access to wifi via computer
- Fluency in English at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes)
Who cannot join
- Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)
- Participation in another intervention study within the last 3 months
- Currently pregnant or intending to become pregnant during the study (assessed by self-report)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
Stanford University
Palo Alto, California, 94305
About this study
Official title: Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults With T1D: Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.
Read the detailed description
In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.
- Conditions
- Type 1 Diabetes
- Being tested
- Psychoeducation to reduce diabetes distress and improve glycemic 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.
Psychoeducation to reduce diabetes distress and improve glycemic outcomesBehavioural
The intervention includes two types of sessions - those targeting an improvement in glycemic outcomes and those targeting a reduction in diabetes distress. Evidence indicates that psychoeducation and support are needed to improve self-care behaviors and optimize use of advanced diabetes technologies, which, in turn, can help improve diabetes control while also reducing diabetes distress. Participants will receive 4 one-on-one glycemic sessions and 8 one-on-one distress sessions, each lasting ~30 minutes. Sessions will be conducted in-person or remotely. The virtual sessions are intended to provide the extra psychoeducation and support needed for this high risk group without increasing the burden associated with frequent face-to-face sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Intervention Group will receive the monthly intervention sessions during the first year of the study. Receives: Behavioral: Psychoeducation to reduce diabetes distress and improve glycemic outcomes |
| Control Group | No intervention | The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR)
CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.
Measured: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis)
Secondary outcomes (3)
A1c
A1c will be assessed every 6 months. Blood samples will be collected locally using uniform procedures and sent to the central laboratory at the University of Minnesota for analysis. Change in A1c from 0 to 12 months will be compared within and between the intervention group and control group.
Measured: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)
Diabetes Distress
Diabetes distress will be assessed every 6 months using the validated Problem Areas in Diabetes - Pediatric survey (PAID-Peds). The PAID-Peds measures self-reported diabetes distress. The total score can range from 0 to 100, with higher scores indicating more diabetes distress. Change in diabetes distress from 0 to 12 months will be compared within and between the intervention group and control group.
Measured: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)
Attitudes Toward Diabetes Device Use
Attitudes toward diabetes device use will be assessed every 6 months using the validated Glucose Monitoring Satisfaction Survey for Type 1 Diabetes (GMSS-T1D) and the Diabetes Technology Attitudes Scale (DTAS). The GMSS-T1D measures satisfaction with glucose monitoring device (e.g., meter, continuous glucose monitoring system). The total score can range from 1 to 5 and was calculated by averaging all 15 survey items. A higher score indicates more satisfaction. The DTAS measures attitudes about diabetes devices and technology. The total score can range from 5 to 25 and was calculated by summing all 5 survey items. A higher score indicates more positive attitudes about diabetes devices and technology. Change in attitudes toward device use from 0 to 12 months will be compared within and between the intervention group and control group.
Measured: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start26 Jul 2022
- Primary completion30 Nov 2024
- Study completion1 Feb 2026
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.
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Lori M Laffel, MD, MPH, Principal investigator, Joslin Diabetes CenterKorey K Hood, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413239
- Sponsor's protocol ID
- STUDY00000154
- Other IDs
- R01DK129479
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2022
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If we are able to remove all HIPAA-defined identifiers from the final data set to eliminate the possibility of deductive disclosure of participants with unusual characteristics, the investigators will make the final data set available to interested researchers according to the NIH Data Sharing Policy and the criteria below.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults With T1D: Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
- ClinicalTrials.gov ID
- NCT05413239
- Acronym / sponsor ID
- STUDY00000154
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.
Detailed description
In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Psychoeducation to reduce diabetes distress and improve glycemic outcomesThe Intervention Group will receive the monthly intervention sessions during the first year of the study. |
| Control Group | No intervention | –The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 14-25 years
- Diagnosis of type 1 diabetes (according to ADA criteria)
- Type 1 diabetes duration ≥12 months
- A1c 7-13%
- Smartphone or regular access to wifi via computer
Key exclusion criteria (3 listed)
- Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)
- Participation in another intervention study within the last 3 months
- Currently pregnant or intending to become pregnant during the study (assessed by self-report)
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 |
|---|---|---|
| Psychoeducation to reduce diabetes distress and improve glycemic outcomesThe intervention includes two types of sessions - those targeting an improvement in glycemic outcomes and those targeting a reduction in diabetes distress. Evidence indicates that psychoeducation and support are needed to improve self-care behaviors and optimize use of advanced diabetes technologies, which, in turn, can help improve diabetes control while also reducing diabetes distress. Participants will receive 4 one-on-one glycemic sessions and 8 one-on-one distress sessions, each lasting ~30 minutes. Sessions will be conducted in-person or remotely. The virtual sessions are intended to provide the extra psychoeducation and support needed for this high risk group without increasing the burden associated with frequent face-to-face sessions. | Behavioural | Intervention Group |
Primary outcome
Time in Range (TIR)
Time frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis)
CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.
3 secondary outcomes
A1c
Time frame: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)
Diabetes Distress
Time frame: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)
Attitudes Toward Diabetes Device Use
Time frame: 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. If we are able to remove all HIPAA-defined identifiers from the final data set to eliminate the possibility of deductive disclosure of participants with unusual characteristics, the investigators will make the final data set available to interested researchers according to the NIH Data Sharing Policy and the criteria below.
Related trials for Type 1 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Lori M Laffel, MD, MPH principal investigator
Joslin Diabetes Center
Korey K Hood, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation to reduce diabetes distress and improve glycemic outcomes in people with Type 1 Diabetes, run by Joslin Diabetes Center at 2 sites 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 6 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 12 Mar 2026). 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?
Time in Range (TIR) (time frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis)). 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 12 Mar 2026.