Type 1 DiabetesNCT06384911
InvesT1D: Promoting Adolescent Investment in Diabetes Care
A study testing Financial Incentives Program in people with Type 1 Diabetes, run by Harvard Pilgrim Health Care at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes. Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Financial Incentives Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 31 Oct 2027
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with type 1 diabetes ≥12 months
- Utilize a continuous glucose monitor (CGM) to support diabetes management
- Average daily CGM use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day
- Are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
- Cognitively able to participate in incentive program and complete surveys
- Have access to a mobile phone to receive information about goal attainment and incentive updates
- Have the ability to upload glucose and insulin administration data remotely per processes used by participant's diabetes care team
- Caregivers are willing to participate in study and complete surveys
Who cannot join
- At time of screening, average CGM wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day
- Adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
- Cognitively or physically unable to participate
- Adolescent is a ward of the state
- Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
- Caregivers are not willing to participate in study and complete surveys
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, 1 recruiting
- Recruiting
Seattle Children's
Seattle, Washington, 98105
Ciara A DeGraff, BA, 206-884-1809, ciara.degraff@seattlechildrens.org
Beth Loots, MPH, MSW, 206-884-4488, beth.loots@seattlechildrens.org
About this study
The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.
Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.
Read the detailed description
Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management.
The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual.
Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.
- Conditions
- Type 1 Diabetes
- Being tested
- Financial Incentives Program
- 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.
Financial Incentives ProgramBehavioural
Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
| Study group | Role | What they receive |
|---|---|---|
| Group A (low-value incentive, 6 months [24 weeks]) | Experimental | If the participant is assigned to Group A, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $294 over a period of 24 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $66 over a period of 24 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $360 over a period of 24 weeks. Receives: Behavioral: Financial Incentives Program |
| Group B (high-value incentive, 6 months [24 weeks]) | Experimental | If the participant is assigned to Group B, they would receive $3.50 for each day that they meet their diabetes self-management goal. This equates to up to $98 every 4 weeks ($3.50 x 28 days = $98), or up to $588 over a period of 24 weeks. They would also receive $5.50 for each week that they meet their clinical outcome goal. This equates to up to $22 every 4 weeks ($5.50 x 4 weeks), or up to $132 over a period of 24 weeks. In total, they could earn up to $120 ($98 + $22) every 4 weeks, or up to $720 over a period of 24 weeks. Receives: Behavioral: Financial Incentives Program |
| Group C (low-value incentive, 12 months [48 weeks]) | Experimental | If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks. Receives: Behavioral: Financial Incentives Program |
| Group D (high-value incentive, 12 months [48 weeks]) | Experimental | If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks. Receives: Behavioral: Financial Incentives Program |
| Group E (usual care, 6 months [24 weeks]) | No intervention | Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Group F (usual care, 12 months [48 weeks]) | No intervention | Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time In Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL)
Measured: Change over 12-18 months
Secondary outcomes (10)
Time Above Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).
Measured: Change over 12-18 months
Time Below Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).
Measured: Change over 12-18 months
Hemoglobin A1c (HbA1c)
HbA1c laboratory measurements collected during the intervention.
Measured: Change over 12-18 months
Diabetes Distress
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (scale: 14-84).
Measured: Change over 12-18 months
Diabetes Family Conflict
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (scale: 19-57).
Measured: Change over 12-18 months
Adolescent Quality of Life
Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status (scale: 0-100).
Measured: Change over 12-18 months
Caregiver Quality of Life
Caregiver quality of life will be assessed using the Care-related Quality of Life instrument. Higher scores represent higher caregiving burden (score: 0-100).
Measured: Change over 12-18 months
Diabetic Ketoacidosis
Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.
Measured: 12-18 months
Severe Hypoglycemia
Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.
Measured: 12-18 months
Insulin Adminstration
Daily bolus insulin administration will be assessed based on data collected on insulin pump or inPen diabetes data management platforms.
Measured: Change over 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start25 Jun 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Davene R. Wright, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384911
- Sponsor's protocol ID
- STUDY00004543
- Status last verified
- Dec 2025
- First submitted
- 22 Apr 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Dataverse repository provides searchable study-level metadata for dataset discovery. The repository assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. The dataset will be tagged with the NIH award number to facilitate searches.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InvesT1D: Promoting Adolescent Investment in Diabetes Care
- ClinicalTrials.gov ID
- NCT06384911
- Acronym / sponsor ID
- STUDY00004543
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Apr 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 this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.
Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.
Detailed description
Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management.
The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual.
Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A (low-value incentive, 6 months [24 weeks]) | Experimental | Behavioral: Financial Incentives ProgramIf the participant is assigned to Group A, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $294 over a period of 24 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $66 over a period of 24 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $360 over a period of 24 weeks. |
| Group B (high-value incentive, 6 months [24 weeks]) | Experimental | Behavioral: Financial Incentives ProgramIf the participant is assigned to Group B, they would receive $3.50 for each day that they meet their diabetes self-management goal. This equates to up to $98 every 4 weeks ($3.50 x 28 days = $98), or up to $588 over a period of 24 weeks. They would also receive $5.50 for each week that they meet their clinical outcome goal. This equates to up to $22 every 4 weeks ($5.50 x 4 weeks), or up to $132 over a period of 24 weeks. In total, they could earn up to $120 ($98 + $22) every 4 weeks, or up to $720 over a period of 24 weeks. |
| Group C (low-value incentive, 12 months [48 weeks]) | Experimental | Behavioral: Financial Incentives ProgramIf the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks. |
| Group D (high-value incentive, 12 months [48 weeks]) | Experimental | Behavioral: Financial Incentives ProgramIf the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks. |
| Group E (usual care, 6 months [24 weeks]) | No intervention | –Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Group F (usual care, 12 months [48 weeks]) | No intervention | –Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with type 1 diabetes ≥12 months
- Utilize a continuous glucose monitor (CGM) to support diabetes management
- Average daily CGM use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day
- Are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
- Cognitively able to participate in incentive program and complete surveys
Key exclusion criteria (6 listed)
- At time of screening, average CGM wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day
- Adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
- Cognitively or physically unable to participate
- Adolescent is a ward of the state
- Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
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 |
|---|---|---|
| Financial Incentives ProgramAdolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals. | Behavioural | Group A (low-value incentive, 6 months [24 weeks]), Group B (high-value incentive, 6 months [24 weeks]), Group C (low-value incentive, 12 months [48 weeks]), Group D (high-value incentive, 12 months [48 weeks]) |
Primary outcome
Time In Range
Time frame: Change over 12-18 months
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL)
10 secondary outcomes
Time Above Range
Time frame: Change over 12-18 months
Time Below Range
Time frame: Change over 12-18 months
Hemoglobin A1c (HbA1c)
Time frame: Change over 12-18 months
Diabetes Distress
Time frame: Change over 12-18 months
Diabetes Family Conflict
Time frame: Change over 12-18 months
Adolescent Quality of Life
Time frame: Change over 12-18 months
Caregiver Quality of Life
Time frame: Change over 12-18 months
Diabetic Ketoacidosis
Time frame: 12-18 months
Severe Hypoglycemia
Time frame: 12-18 months
Insulin Adminstration
Time frame: Change over 12-18 months
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. The Harvard Dataverse repository provides searchable study-level metadata for dataset discovery. The repository assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. The dataset will be tagged with the NIH award number to facilitate searches.
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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 Financial Incentives Program in people with Type 1 Diabetes, run by Harvard Pilgrim Health Care 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Dec 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?
Contact Catherine Pihoker, MD (206-987-2637, catherine.pihoker@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time In Range (time frame: Change over 12-18 months). 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 16 Dec 2025.