Type 1 DiabetesInvesT1DNCT04516694
Promoting Adolescent Investment In Diabetes Care
A study testing Financial incentive (gain) and Financial incentive (loss) in people with Type 1 Diabetes, run by Harvard Pilgrim Health Care at 1 site in United States.
Trial summary
Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Financial incentive (gain) and Financial incentive (loss)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 8 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- >12 and ≤18 years old
- Diagnosed with type 1 diabetes ≥12 months
- Speaks English fluently
- Cognitively able to participate in incentive program and complete surveys.
- Have access to a mobile phone to receive goal-obtainment and incentive updates
- Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic
- Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics
Who cannot join
- Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
- Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
- Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
- Cognitively or physically unable to participate
- Patient is unable to speak in the English language
- Patient is unable to read in the English language
- Patient is a ward of the state
- Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98121
About this study
Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.
Read the detailed description
Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).
- Conditions
- Type 1 Diabetes
- Being tested
- Financial incentive (gain), Financial incentive (loss)
- Keywords
- behavioral economics, financial incentive, diabetes, type 1 diabetes, adolescent, AYA, young adult
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentive (gain)Behavioural
Participants will receive a daily financial incentive framed as a gain with money allocated each day of adherence to a self-care coal. Participants will receive an additional weekly incentive for meeting a clinical outcome goal.
Financial incentive (loss)Behavioural
Participants will receive a daily financial incentive framed as a loss with money allocated up front and taken away each day of non-adherence to a self-care coal. An additional weekly incentive will be deducted for failure to meet a clinical outcome goal.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care reflects the standard treatment currently provided to T1D patients. 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. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Gain-framed incentive | Experimental | Participants will start off with nothing at the beginning of the treatment period. For each day that participants' meet goals, value will be added to their incentive balance.
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. Telephone consultations are available 24/7 as often as necessary between clinic visits. Receives: Behavioral: Financial incentive (gain) |
| Loss-framed incentive | Experimental | Participants will start off at the maximum incentive balance at the beginning of the treatment period and for each day that participants' fail to meet goals, value will be subtracted from their incentive balance over the 12-week.
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. Telephone consultations are available 24/7 as often as necessary between clinic visits. Receives: Behavioral: Financial incentive (loss) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c from baseline to 12 weeks
Measured: 12 weeks
Secondary outcomes (6)
Glucose monitoring
Frequency of glucose monitoring
Measured: 12 weeks
Insulin Administration
Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant
Measured: 12 weeks
SCI-R
The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations
Measured: 12 weeks
PAID-T
Problem Areas in Diabetes- Teen version
Measured: 12 weeks
DFCS
Diabetes Family Conflict Scale
Measured: 12 weeks
Time in Range
Evaluation of percentage of time spent in goal range via continuous glucose monitor system
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start10 Sep 2020
- Primary completion21 Dec 2021
- Study completion8 Jan 2022
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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
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
- NCT04516694
- Sponsor's protocol ID
- 1540260
- Acronym
- InvesT1D
- Status last verified
- Mar 2024
- First submitted
- 13 Aug 2020
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adolescent Investment In Diabetes Care
- ClinicalTrials.gov ID
- NCT04516694
- Acronym / sponsor ID
- InvesT1D / 1540260
- Conditions
- Type 1 Diabetes
- Keywords
- behavioral economics, financial incentive, diabetes, type 1 diabetes, adolescent, AYA, young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 18 Aug 2020 (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.
Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.
Detailed description
Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care reflects the standard treatment currently provided to T1D patients. 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. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Gain-framed incentive | Experimental | Behavioral: Financial incentive (gain)Participants will start off with nothing at the beginning of the treatment period. For each day that participants' meet goals, value will be added to their incentive balance. 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. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
| Loss-framed incentive | Experimental | Behavioral: Financial incentive (loss)Participants will start off at the maximum incentive balance at the beginning of the treatment period and for each day that participants' fail to meet goals, value will be subtracted from their incentive balance over the 12-week. 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. Telephone consultations are available 24/7 as often as necessary between clinic visits. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- >12 and ≤18 years old
- Diagnosed with type 1 diabetes ≥12 months
- Speaks English fluently
- Cognitively able to participate in incentive program and complete surveys.
- Have access to a mobile phone to receive goal-obtainment and incentive updates
Key exclusion criteria (8 listed)
- Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
- Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
- Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
- Cognitively or physically unable to participate
- Patient is unable to speak in the English language
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 incentive (gain)Participants will receive a daily financial incentive framed as a gain with money allocated each day of adherence to a self-care coal. Participants will receive an additional weekly incentive for meeting a clinical outcome goal. | Behavioural | Gain-framed incentive |
| Financial incentive (loss)Participants will receive a daily financial incentive framed as a loss with money allocated up front and taken away each day of non-adherence to a self-care coal. An additional weekly incentive will be deducted for failure to meet a clinical outcome goal. | Behavioural | Loss-framed incentive |
Primary outcome
HbA1c
Time frame: 12 weeks
Change in HbA1c from baseline to 12 weeks
6 secondary outcomes
Glucose monitoring
Time frame: 12 weeks
Insulin Administration
Time frame: 12 weeks
SCI-R
Time frame: 12 weeks
PAID-T
Time frame: 12 weeks
DFCS
Time frame: 12 weeks
Time in Range
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 incentive (gain) and Financial incentive (loss) 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 7 inclusion and 8 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 5 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 12 weeks). 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 Mar 2024.