Seattle Children's Research Institute
Seattle, Washington, 98121, United States
NCT Number: NCT04516694
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.
Looking for future studies?
Notify Me12 year–18 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98121, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks
Change in HbA1c from baseline to 12 weeks
Time frame: 12 weeks
Frequency of glucose monitoring
Time frame: 12 weeks
Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant
Time frame: 12 weeks
The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations
Time frame: 12 weeks
Problem Areas in Diabetes- Teen version
Time frame: 12 weeks
Diabetes Family Conflict Scale
Time frame: 12 weeks
Evaluation of percentage of time spent in goal range via continuous glucose monitor system
Harvard Pilgrim Health Care
Other
Acronym: InvesT1D
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.
Published trials that share one or more normalized conditions with this study.
NCT01897688
Autoimmune Diseases, Diabetes Mellitus
Chicago, Illinois, United States
View Trial DetailsNCT06494722
Autoimmune Diseases, Diabetes Mellitus
Atlanta, Georgia, United States
View Trial DetailsNCT05229718
Autoimmune Diseases, Diabetes Mellitus
Boston, Massachusetts, United States
View Trial DetailsNCT01354288
Acid-Base Imbalance, Acidosis
Le Kremlin-Bicêtre, France
View Trial Details