Background: Insulin pump users experience periods of unexplained hyperglycemia. In some cases these may be due to insulin flow interruptions termed “silent occlusions,” which occur without activating the pump alarm and may require set replacement.Materials and Methods: In-line pressure profiles of a novel infusion set with a 6-mm, 28-gauge polymer, dual-ported catheter (BD FlowSmart™; Becton Dickinson and Co., Franklin Lakes, NJ) were compared with those of an existing infusion set (Quick-set®; Medtronic MiniMed, Northridge, CA) in two separate studies involving insulin diluent infusions over 2.5–4.5-h periods in healthy adults without diabetes. Study 1, a pilot study (n = 25), compared the occurrence of flow interruption events (silent occlusions and/or occlusion alarms) between the two infusion sets and between manual or device-assisted insertion methods. Study 2 (n = 60) was designed to show ≥50% reduction in flow interruption events with the BD set after manual insertions. (Silent occlusions were defined by a continuous pressure rise for ≥30 min.)Results: In Study 1, significantly fewer silent occlusions were seen with BD FlowSmart versus Quick-set infusion sets for both manual (three of 22 [13.6%] vs. 12 of 24 [50%]; P = 0.012) and mechanical (two of 24 [8.3%] vs. nine of 25 [36%]; P = 0.037) insertions, yielding risk reductions of 73% (95% confidence interval [CI], 25–91%) and 77% (95% CI, 17–94%), respectively. In Study 2, flow interruption events occurred in three of 117 (2.6%) and 12 of 118 (10.2%) BD FlowSmart and Quick-set infusion sets, respectively, yielding a 75% risk reduction (95% CI, 20–92%; P = 0.030). Percentage of time with flow interruption was significantly lower with BD sets in both studies (P < 0.02). Leakage (>0.5 IU or 5 μL) occurred infrequently and did not differ between sets.Conclusions: A novel side-ported insulin infusion set demonstrated significant reductions in flow interruptions, including silent occlusions, versus a leading marketed set, which may improve insulin delivery.
The management of diabetes mellitus requires a precise interpretation of blood glucose (BG) data by patients and providers and is increasingly associated with a need for medical technologies that aid in achieving patient-specific outcomes while making the process convenient. This review aims to summarize the current landscape in diabetes management technology, focusing specifically on devices that assist with pattern management in patients with type 2 diabetes (T2DM) who are on multiple-dose insulin regimens. Data Sources: The authors searched MEDLINE to identify articles from 2007 to 2018 that evaluated technologies for BG pattern management and diabetes monitoring. Additional references were generated through review of identified literature citations. Article selection was based on mutual agreement for inclusion. Data Selection and Data Extraction: Relevant articles were defined as English-language articles, describing technologies that assist with diabetes management in insulin-injecting patients with T2DM. Articles that focused exclusively on type 1 diabetes were excluded. Data Synthesis: The literature search yielded 334 articles, of which 21 were included for synthesis. The current BG monitoring practices emphasize the benefit of the structured self-monitoring of BG approach. Several randomized controlled trials conclude that the available technology aids in comprehensive data collection and facilitates communication between patients and providers. Digitally enabled "smart" devices are valuable tools that may help improve outcomes while providing a flexible, personalized approach. Conclusions: Integration of digital technology with diabetes management allows for accurate collection and analysis of data. Emergence of digital tools promotes a comprehensive, precise, and objective approach to glucose monitoring and encourages patient-provider collaborations.
Objective: Accuracy is recognized as an important attribute of continuous glucose monitors (CGMs). The objective of this research was to understand if improvements in CGM accuracy impact clinical outcomes in patients with T1DM or T2DM. Research Design and Methods: A review of literature published from January 1999 to June 2017 was conducted using Medline. Articles were included if they reported desired outcome measures of clinical efficacy (HbA1c reduction, time-in-range [TIR], hypoglycemia detection or reduction) regardless of patient diabetes type. Simple linear and multiple regressions were utilized to evaluate the relationship between mean absolute relative difference (MARD) and measures of efficacy. Results: The literature search yielded 574 results from which 20 articles met the inclusion criteria. MARD for commercialized CGM devices improved, on average, 0.75% per year (R2=0.87, p<0.0001). There was no significant correlation between HbA1c reduction and MARD (coefficient=0.464, R2=0, p=0.8857). A significant relationship was observed between MARD and the detection of hypoglycemic events (coefficient= -0.33, R2=0.63, p<0.0001). Insufficient data was available to assess the correlation between accuracy and TIR or hypoglycemia reduction. Conclusion: CGM accuracy correlates with an increased detection of hypoglycemic events, but not with HbA1c reduction. Disclosure C.J. Koziel: None. D. Bialonczyk: Employee; Self; Becton, Dickinson and Company. D. Morel: Employee; Self; Becton, Dickinson and Company. J. Petisce: None. D. Saliu: Employee; Self; Becton, Dickinson and Company.
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