Abstract
Background: This observational study investigated whether the connected NovoPen® 6 could influence insulin regimen management and glycemic control in people with type 1 diabetes (T1D) using a basal-bolus insulin regimen and continuous glucose monitoring in a real-world setting.Methods: Participants from 12 Swedish diabetes clinics downloaded pen data at each visit (final cohort: n = 94). Outcomes included time in range (TIR; sensor glucose 3.9–10.0 mmol/L), time in hyperglycemia (>10 mmol/L), and hypoglycemia (L1: 3.0– <3.9 mmol/L; L2: <3.0 mmol/L). Missed bolus dose (MBD) injections were meals without bolus injection within −15 and +60 min from the start of a meal. Outcomes were compared between the baseline and follow-up periods (≥5 health care professional visits). Data were analyzed from the first 14 days following each visit. For the TIR and total insulin dose analyses (n = 94), a linear mixed model was used, and for the MBD analysis (n = 81), a mixed Poisson model was used.Results: TIR significantly increased (+1.9 [0.8; 3.0]95% CI h/day; P < 0.001) from baseline to follow-up period, with a corresponding reduction in time in hyperglycemia (−1.8 [−3.0; −0.6]95% CI h/day; P = 0.003) and L2 hypoglycemia (−0.3 [−0.6; −0.1]95% CI h/day; P = 0.005), and no change in time in L1 hypoglycemia. MBD injections decreased by 43% over the study (P = 0.002). Change in MBD injections corresponded to a decrease from 25% to 14% based on the assumption that participants had three main meals per day.Conclusions: Our study highlights the potential benefit on glycemic control and dosing behavior when reliable insulin dose data from a connected pen contribute to insulin management in people with T1D.
Highlights
This observational study investigated whether the connected NovoPenÒ 6 could influence insulin regimen management and glycemic control in people with type 1 diabetes (T1D) using a basal-bolus insulin regimen and continuous glucose monitoring in a real-world setting
time in range (TIR) significantly increased (+1.9 [0.8; 3.0]95% CI h/day; P < 0.001) from baseline to follow-up period, with a corresponding reduction in time in hyperglycemia (-1.8 [-3.0; -0.6]95% CI h/day; P = 0.003) and Level 2 (L2) hypoglycemia (-0.3 [-0.6; -0.1]95% CI h/day; P = 0.005), and no change in time in Level 1 (L1) hypoglycemia
Many people treated with insulin fail to reach their glycemic targets, which is known to increase the risk of microvascular and macrovascular complications, resulting in substantial morbidity and mortality.[13,14,24]. Our findings in this observational study in adults with T1D using continuous glucose monitoring (CGM) highlight the potential benefits on glycemic control and injection behavior when connected pen data contribute to insulin treatment
Summary
Regardless of diabetes type, many people treated with insulin struggle to take their medication on time and maintain their treatment regimen over extended periods of time.[1,2,3,4] Difficulties with insulin dosing and inaccurate dose timing have been shown to result in poor glycemic control for people with diabetes.[5,6] The impact of missed insulin injections on HbA1c levels is well established,[7,8,9,10,11,12] leading to an increasing risk of diabetes-related complications.[13,14]Technological advances offer opportunities to optimize insulin delivery, reduce dosing errors, and improve regimen management. This observational study investigated whether the connected NovoPenÒ 6 could influence insulin regimen management and glycemic control in people with type 1 diabetes (T1D) using a basal-bolus insulin regimen and continuous glucose monitoring in a real-world setting. Results: TIR significantly increased (+1.9 [0.8; 3.0]95% CI h/day; P < 0.001) from baseline to follow-up period, with a corresponding reduction in time in hyperglycemia (-1.8 [-3.0; -0.6]95% CI h/day; P = 0.003) and L2 hypoglycemia (-0.3 [-0.6; -0.1]95% CI h/day; P = 0.005), and no change in time in L1 hypoglycemia. Conclusions: Our study highlights the potential benefit on glycemic control and dosing behavior when reliable insulin dose data from a connected pen contribute to insulin management in people with T1D
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