Shital Kamble1, Kevin P Weinfurt1,2, Kevin A Schulman1,3, Shelby D Reed1,3. 1. Duke Clinical Research Institute (SK, KPW, KAS, SDR) 2. Departments of Psychiatry and Behavioral Sciences, (KPW), Duke University School of Medicine, Durham, North Carolina 3. Departments of Medicine (KAS, SDR), Duke University School of Medicine, Durham, North Carolina
Abstract
BACKGROUND:Sensor-augmented pump therapy (SAPT) leads to lower glycated hemoglobin levels than multiple daily injections of insulin (MDI) in patients with type 1 diabetes. Patient time and costs associated with SAPT are not known. OBJECTIVE: We compared time spent on diabetes-related care, changes in time, and associated patient time costs between patients randomly assigned to SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a 52-week clinical trial, participants aged 7 to 70 years (n = 483) reported total time per week spent on diabetes-related care. MEASUREMENTS: Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation. RESULTS: At baseline, patients in the MDI group reported spending an average of 4.0 hours per week on diabetes-related care. During the pump initiation period (weeks 1-7), SAPT patients spent 1.9 hours more per week than MDI patients (95% confidence interval [CI], 1.2-2.6). After the initiation period (weeks 8-52), SAPT patients spent 1 hour more per week (95% CI, 0.4-1.7) than MDI patients (i.e., 4.4 v. 3.4 hours); patients in both groups spent progressively less time on diabetes-related care by 1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean time costs per person were $4600 with the SAPT group and $3523 with the MDI group (difference, $1077; 95% CI, $491-$1638). LIMITATIONS: Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities. CONCLUSIONS: Patients receiving SAPT v. MDI spent approximately 2 hours more per week on diabetes-related care during pump initiation and 1 hour more per week thereafter, resulting in higher patient time costs.
RCT Entities:
BACKGROUND: Sensor-augmented pump therapy (SAPT) leads to lower glycated hemoglobin levels than multiple daily injections of insulin (MDI) in patients with type 1 diabetes. Patient time and costs associated with SAPT are not known. OBJECTIVE: We compared time spent on diabetes-related care, changes in time, and associated patient time costs between patients randomly assigned to SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a 52-week clinical trial, participants aged 7 to 70 years (n = 483) reported total time per week spent on diabetes-related care. MEASUREMENTS: Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation. RESULTS: At baseline, patients in the MDI group reported spending an average of 4.0 hours per week on diabetes-related care. During the pump initiation period (weeks 1-7), SAPT patients spent 1.9 hours more per week than MDIpatients (95% confidence interval [CI], 1.2-2.6). After the initiation period (weeks 8-52), SAPT patients spent 1 hour more per week (95% CI, 0.4-1.7) than MDIpatients (i.e., 4.4 v. 3.4 hours); patients in both groups spent progressively less time on diabetes-related care by 1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean time costs per person were $4600 with the SAPT group and $3523 with the MDI group (difference, $1077; 95% CI, $491-$1638). LIMITATIONS: Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities. CONCLUSIONS:Patients receiving SAPT v. MDI spent approximately 2 hours more per week on diabetes-related care during pump initiation and 1 hour more per week thereafter, resulting in higher patient time costs.