Seattle Children's
Seattle, Washington, 98105, United States
Location status: Recruiting
Location contact
Beth Loots, MPH, MSW
CONTACT
Catherine Pihoker, MD
PRINCIPAL_INVESTIGATOR
Ciara A DeGraff, BA
CONTACT
NCT Number: NCT06384911
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.
Interested in participating?
Request Info12 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98105, United States
Location status: Recruiting
Beth Loots, MPH, MSW
CONTACT
Catherine Pihoker, MD
PRINCIPAL_INVESTIGATOR
Ciara A DeGraff, BA
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
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)
Time frame: Change over 12-18 months
Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).
Time frame: Change over 12-18 months
Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).
Time frame: Change over 12-18 months
HbA1c laboratory measurements collected during the intervention.
Time frame: Change over 12-18 months
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (scale: 14-84).
Time frame: Change over 12-18 months
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (scale: 19-57).
Time frame: Change over 12-18 months
Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status (scale: 0-100).
Time frame: Change over 12-18 months
Caregiver quality of life will be assessed using the Care-related Quality of Life instrument. Higher scores represent higher caregiving burden (score: 0-100).
Time frame: 12-18 months
Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.
Time frame: 12-18 months
Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.
Time frame: Change over 12-18 months
Daily bolus insulin administration will be assessed based on data collected on insulin pump or inPen diabetes data management platforms.
Contact information is provided by the study sponsor or research team.
Harvard Pilgrim Health Care
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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