Improved Glycemic Control Observed in Children with Type 1 Diabetes Following the Introduction of Smart Insulin Pens: A Real-World Study

Abstract

Introduction Many challenges are associated with optimizing glycemic control in pediatric patients with type 1 diabetes (T1D); combining data from smart insulin pens and continuous glucose monitoring (CGM) could mitigate some of these obstacles. Methods This one-arm, prospective, observational study investigated the effects of introducing a smart pen on glycemic control in pediatric patients with T1D who were using CGM. Children and adolescents with T1D who had been prescribed a smart pen for basal and/or bolus insulin injections were enrolled from three clinics in Sweden. Outcomes compared between baseline and follow-up (≥ 12 months) included: mean numbers of daily (over 24 h) and nocturnal hypoglycemic or hyperglycemic events; time above range (TAR; > 180 mg/dL); time below range (TBR; level 1: 54 to < 70 mg/dL; level 2: < 54 mg/dL); time in range (TIR; 70–180 mg/dL); and missed bolus-dose (MBD) meals. Results Overall, 39 patients were included. Mean numbers of daily hypoglycemic events (− 31.4%; p = 0.00035) and nocturnal hypoglycemic events (− 24.4%; p = 0.043) were significantly reduced from baseline to follow-up. Mean daily TBR level 2 was reduced from 2.82% at baseline to 2.18% at follow-up (− 0.64 percentage points; p = 0.025). There were no statistically significant changes in number of daily hyperglycemic events, MBD meals, TIR, TAR, or TBR level 1. Conclusions Introducing smart insulin pens was associated with a reduced number of hypoglycemic events and decreases in TBR level 2, demonstrating a potential benefit for glycemic control in pediatric patients. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01177-w.

Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control

“…Today, with greater advances in the technology of the CIP, it integrates with CGM and even integrates with mobile apps to help users to calculate bolus doses easily with a bolus calculator, and finally, all the data are submitted to a virtual platform. Several studies have shown that the emergence of new technologies overcome barriers and report better glycemic outcomes than pens without the function [41][42][43]. Currently, a few clinical trials are collecting data on the effectiveness of these CIPs.…”

“…However, it does not offer injection reminders or IOB display. Two observation studies have evaluated the efficacy of NovoPen 6 integrating with CGM, one in adults and the other in pediatric patients [ 42 , 43 ]. Adolfsson et al [ 42 ] revealed significant changes during the 12-month follow-up period, with an 8.5% (1.9 hour/day) increase of TIR, 6.2% decrease of TAR (>180 mg/dL, 1.8 hour/day), and 1.5% TBR (<54 mg/dL, 0.3 hour/day) in 94 patients with T1DM.…”

“…In another study, they found that the TBR (<54 mg/dL) reduces by 0.64% from 2.82% to 2.18% in at least 12 months of follow-up in 39 pediatric patients with T1DM. However, there were no changes in MBD meals, TIR, and TAR (>180 mg/dL) [ 43 ].…”

Clinical, Economic, and Patient-Reported Benefits of Connected Insulin Pen Systems: A Systematic Literature Review

“…The six observational studies included were prospective cohort studies that assessed connected caps (Insulclock Ò , GoCap Ò ), connected insulin pens (NovoPen Ò 6; Bravo pen Ò , InPen Ò ), or a connected insulin platform (ESYSTA Ò ). Of these, one subgroup analysis (evaluating NovoPen Ò 6) was fully published [33], four, with an additional subgroup analysis, were conference abstracts [31,[34][35][36][37], and the one evaluating a connected insulin platform (ESYSTA Ò ) was a white paper [27]. These core publications were associated with several supporting publications [32,[38][39][40][41][42][43][44][45][46][47][48][49][50].…”

“…Of the studies evaluating Insulclock Ò , two included people with type 1 diabetes mellitus (T1DM) [32,36] and one included people with type 2 diabetes mellitus (T2DM) [29]. Single studies evaluated GoCap Ò , Bravo pen Ò , InPen Ò , and ESYSTA Ò in people with T1DM or T2DM [27,31,34,35], and two parts of one study [40] evaluated NovoPen Ò 6 (one in adults with T1DM and the other in children and adolescents with T1DM) [33,37].…”