Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial

Brazg, Ron L; Garg, Satish K.; Bhargava, Anuj; Thasher, James R; Latif, Kashif; Bode, Bruce W.; Bailey, Timothy S.; Horowitz, Barry Scot; Cavale, Arvind; Kudva, Yogish C.; Kaiserman, Kevin; Grunberger, George; Reed, John H.; Chattaraj, Sarnath; Zhang, Gina; Shin, John; Chen, Vivian; Lee, Scott W.; Cordero, Toni L.; Rhinehart, Andrew S.; Vigersky, Robert A.; Buckingham, Bruce A.

doi:10.1089/dia.2021.0540

Cited by 14 publications

(25 citation statements)

References 21 publications

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“…• • One cross-over study of two different regular IISs 24 ; and • • Three single-arm studies of extended IIS use for seven days or more. 12,14,17 Figure 4 shows the map of IIS comparisons for the outcomes of wear duration, TDD, and IIS failure reasons/modes. Metaanalysis results were based on these outcomes and are presented in the following paragraphs.…”

Section: Discussionmentioning

confidence: 99%

Advances in Insulin Infusion Set in the New Era of Automated Insulin Delivery: A Systematic Review

Zhang

Romo-Anselmo

Kwa

et al. 2022

J Diabetes Sci Technol

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Introduction: Automated insulin delivery (AID) has become a well-known research topic devoted to achieving better glycemic outcomes. AID systems consist primarily of three components: the continuous glucose monitoring system, the insulin delivery system, either tethered or patch pump, and the control system (algorithm). A key component in the tethered pump AID system is the insulin infusion set (IIS). This Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) study was conducted to evaluate the IIS evolution in the era of AID and to provide future perspectives of IIS clinical use. Methods: Literature searches for articles published from January 2016 to July 2022 were performed in Embase/Medline and PubMed. Data were extracted following PRISMA guidelines. Primary meta-analysis outcomes were IIS wear duration, total daily dose of insulin, and IIS failure reasons/modes. Results: We identified 387 publications, of which 15 eligible studies compared various IISs comprising over 1400 participants and >53 000 wears. Half of the studies published in 2022 were focused on extended IISs designed for wear durations of seven days or more. Three clinical trials have demonstrated the safe use of extended IISs to seven days of wear in individuals with type 1 diabetes, and two also demonstrated good glycemic control throughout the seven-day use. Conclusions: Research in insulin infusion technology has increased in the last six years, and extended IISs have demonstrated improved overall performance, particularly in duration of wear. Paths for future products are discussed with an emphasis on understanding the existing barriers related to both technical and nontechnical issues.

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Section: Discussionmentioning

confidence: 99%

Advances in Insulin Infusion Set in the New Era of Automated Insulin Delivery: A Systematic Review

Zhang

Romo-Anselmo

Kwa

et al. 2022

J Diabetes Sci Technol

Self Cite

View full text Add to dashboard Cite

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“…One additional correction bolus can be given, and glucose must improve by ≥2.8 mmol/L within 90 minutes following second bolus. 5 3. Removal per investigator's discretion, with complete documentation of the reason.…”

Section: Discussionmentioning

confidence: 99%

“…We also propose that a predefined, objective adjudication process for determining IIS failure can further refine data integrity and clinical relevance of the results: Glucose ≥13.9 mmol/L (250 mg/dL) for 60 minutes or longer with ketones >1.0 mmol/L, in the absence of illness or other physiological stress. Glucose ≥13.9 mmol/L (250 mg/dL), ≥3 hours following a snack/meal, AND failure to respond to one corrective pump bolus with a fall of at least 2.8 mmol/L (50 mg/dL) within 60 minutes after bolus delivery. One additional correction bolus can be given, and glucose must improve by ≥2.8 mmol/L within 90 minutes following second bolus 5 Removal per investigator's discretion, with complete documentation of the reason. …”

Section: Discussionmentioning

confidence: 99%

“…Currently, there is a trend toward developing extended-wear insulin infusion sets (Ex-IISs) to continuously infuse insulin subcutaneously for 7 days or longer. [1][2][3][4][5] Replacing an insulin infusion set (IIS) every 2 to 3 days is costly as well as tedious and increases the risk of loss of potent infusion sites. 4,[6][7][8] Little is known about the ideal design of human trials of Ex-IISs, and researchers have limited experience of testing device survival rates beyond 3 days of use.…”

Section: Introductionmentioning

confidence: 99%

“…Currently, there is a trend toward developing extended‐wear insulin infusion sets (Ex‐IISs) to continuously infuse insulin subcutaneously for 7 days or longer 1‐5 . Replacing an insulin infusion set (IIS) every 2 to 3 days is costly as well as tedious and increases the risk of loss of potent infusion sites 4,6‐8 …”

Section: Introductionmentioning

confidence: 99%

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