Introduction: Despite advancements in diabetes technology, some adolescents, and emerging adults with type 1 diabetes (T1D) remain on insulin injections. There is a need to reduce the burden of managing T1D in adolescents who use insulin injections.
Objective: To determine whether a smart insulin pen (InPen™) alters the glycemic control, glucose variability, burden of diabetes care, and parental experience in adolescents and emerging adults with T1D.
Methods: We performed a randomized, cross-over prospective pilot trial in participants 13-21 years with T1D. Participants were randomized to either 90 days of standard multiple daily injection management with continuous glucose monitor (CGM) use or 90 days of InPen™ and CGM use with a cross-over design, switching to the other arm for 90 days. We assessed diabetes control, diabetes distress, transition readiness, and parental experience of illness scales.
Results: Fourteen participants were enrolled in the trial, 1 withdrew. At baseline, median HbA1C was 8.1%, (IQR 7.7, 9.1). There was no statistically significant change in HbA1C, average glucose, glucose SD, total insulin dose, or time in range using the InPen™ relative to standard of care. Participants using the InPen™ had declining engagement with time, calculator use was 41.5% (IQR 5.0, 84.0) and 7% (IQR 0.0, 59.0) at 30 and 90 days, respectively. Questionnaire outcomes did not demonstrate statistically significant differences between treatments; diabetes distress did improve but not statistically significant.
Conclusion: InPen ™ use was not associated with improved diabetes control but did trend to decreasing diabetes distress. Low InPen™ calculator use could be a potential factor for the lack of improvement in glycemic control. Larger studies are warranted to study the effect of smart insulin pen technology on glycemic metrics and diabetes-related burdens in adolescents and emerging adults with T1D.
S.Jackson: Research Support; Medtronic. S.Kumar: None. A.Al nofal: None. R.Hentz: None. S.Pittock: None. A.Creo: None.