Pump It Up! A randomized clinical trial to optimize insulin pump self-management behaviors in adolescents with type 1 diabetes

Holly K O'Donnell; Tim Vigers; Suzanne Bennett Johnson; Laura Pyle; Nancy Wright; Larry C Deeb; Kimberly A Driscoll

doi:10.1016/j.cct.2021.106279

Pump It Up! A randomized clinical trial to optimize insulin pump self-management behaviors in adolescents with type 1 diabetes

Contemp Clin Trials. 2021 Mar:102:106279. doi: 10.1016/j.cct.2021.106279. Epub 2021 Jan 11.

Authors

Holly K O'Donnell¹, Tim Vigers², Suzanne Bennett Johnson³, Laura Pyle⁴, Nancy Wright⁵, Larry C Deeb⁶, Kimberly A Driscoll⁷

Affiliations

¹ University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: [email protected].
² University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: [email protected].
³ Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: [email protected].
⁴ University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: [email protected].
⁵ Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: [email protected].
⁶ Florida State University College of Medicine, Department of Medical Humanities and Social Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: [email protected].
⁷ University of Florida, Department of Clinical and Health Psychology, 1225 Center Dr., Gainesville, FL 32610, United States; University of Florida Diabetes Institute, College of Medicine, 1275 Center Dr., Gainesville, FL 32610, United States. Electronic address: [email protected].

Abstract

Individuals with type 1 diabetes (T1D) must engage in a variety of complex and burdensome self-management behaviors daily to maintain near normal blood glucose levels and prevent complications. There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors. The overall objective of the present study, Pump it Up!, was to use objectively downloaded insulin pump data to inform and test two interventions to optimize insulin pump use in adolescents with T1D and their caregivers. Multiphase Optimization Strategy (MOST) was used to achieve the overall goal of this study - to separately test the main effect of the Pump It Up! Personalized T1D Self-Management Behaviors Feedback Report and the main effect of Pump It Up! Problem-Solving Skills intervention to improve T1D self-management behaviors using a 2 × 2 factorial design. The purpose of this paper is to describe the Pump It Up! study design and rationale, and participant baseline characteristics. Longitudinal data analyses will be conducted, and moderating effects of psychosocial factors will be examined in relation to primary (insulin pump self-management behaviors) and secondary (A1C) outcomes.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Blood Glucose
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1* / drug therapy
Glycated Hemoglobin
Humans
Hypoglycemic Agents
Insulin
Self-Management*

Substances

Blood Glucose
Glycated Hemoglobin A
Hypoglycemic Agents
Insulin

Grants and funding

K23 DK091558/DK/NIDDK NIH HHS/United States