Dataset Information

Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear.

ABSTRACT: Insulin exposure varies over 3 days of insulin infusion set (IIS) wear making day-to-day insulin dosing challenging for people with diabetes (PWD). Here we report insulin pharmacodynamic (PD) and pharmacokinetic (PK) data extending these observations to 7 days of IIS wear. PWD (A1C ≤8.5%, C-peptide <0.6 nmol/L, ≥6 months pump use) were enrolled in a crossover euglycemic clamp pilot study comparing conventional Teflon angled IISs with an investigational extended-wear IIS. PK/PD data from six participants were obtained for 5 h postbolus. Although PD data were unstable, PK profiles (pooled data from both groups) of insulin lispro (0.15 U/kg bolus) showed statistically significant progressive decreases from days 0 to 7 for t_max (P < 0.001), C_max (P < 0.05), and mean residence time (P < 0.0001). Area under the insulin concentration curve (AUC_0-300) declined by ∼24% from days 0 to 7 (P < 0.05). These results confirm/extend previous observations showing progressive acceleration of insulin exposure over IIS wear time. This may have implications for PWD and designers of closed-loop algorithms, although larger studies are necessary to confirm this. The study was registered in clinicaltrials.gov (NCT04398030).

SUBMITTER: Kastner JR

PROVIDER: S-EPMC9894594 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear.

Kastner Jasmin R JR Bailey Timothy S TS Strange Poul P Shi Leon L Oberg Keith A KA Strasma Paul J PJ Joseph Jeffrey I JI Muchmore Douglas B DB

Diabetes technology & therapeutics 20221220 2

Insulin exposure varies over 3 days of insulin infusion set (IIS) wear making day-to-day insulin dosing challenging for people with diabetes (PWD). Here we report insulin pharmacodynamic (PD) and pharmacokinetic (PK) data extending these observations to 7 days of IIS wear. PWD (A1C ≤8.5%, C-peptide <0.6 nmol/L, ≥6 months pump use) were enrolled in a crossover euglycemic clamp pilot study comparing conventional Teflon angled IISs with an investigational extended-wear IIS. PK/PD data from six part ...[more]

PMID: 36342853

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Project description:Background: Standard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D). Methods: This single-arm, nonrandomized trial enrolled adults (18-80 years of age) with T1D, who used their own MiniMed™ 670G system with insulin lispro or insulin aspart and the EIS for up to 7 days, across 12 consecutive wears. Safety endpoints included incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), unanticipated adverse device effects (UADEs), severe hypoglycemia (SevHypo), severe hyperglycemia (SevHyper), diabetic ketoacidosis (DKA), and skin infection. The EIS failure rate due to unexplained hyperglycemia (i.e., suspected occlusion), the overall EIS survival rate, glycemic control outcomes (i.e., A1C, mean sensor glucose and time spent in established glucose ranges), total daily insulin delivered, and satisfaction with the EIS were determined. Results: The intention to treat population (n = 259, 48% men, 45.0 ± 14.1 years) wore a total of 3041 EIS devices. No SADE, UADE, or DKA events was reported. Overall rates of SAEs, SevHypo, SevHyper, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years. The rate of EIS failure due to unexplained hyperglycemia at the end of day 7 was 0.1% (95% confidence interval [CI]: 0.03-0.51) and 0.4% (95% CI: 0.16-1.00) for insulin lispro and aspart use, respectively. Overall EIS survival rate at the end of day 7 was 77.8% (95% CI: 76.2-79.3), glycemic control did not change, and participants reported greater satisfaction with the EIS compared with standard IISs worn before the study (P < 0.001). Conclusions: This investigation demonstrates that the EIS, when worn for up to 7 days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with T1D. Clinical Trial Registration number: NCT04113694 (https://clinicaltrials.gov/ct2/show/NCT04113694).

Project description:SIGNIFICANCE:Growing popularity of handheld digital devices imposes significant challenges to our visual system and clinical management. This study aimed to determine the effects of lens design on parameters that may influence the refractive management of pre-presbyopic adult computer users. PURPOSE:To determine the effects of wearing conventional single-vision lenses (SVL) versus progressive addition lenses (PAL) on the working distance and refractive status. METHODS:Adult computer users, recruited from two age cohorts (18 to 25 years, n = 19; 30 to 40 years, n = 45), were prescribed SVLs and PALs designed for use with handheld digital devices. For each lens type, the working distance and refractive shift (post-task - pre-task) were measured immediately after lens delivery (T0) and after 1 month of lens wear (T1). Working distances were recorded with an automatic ultrasound device while the participants were playing a video game. Refractive status through the subjects' glasses was measured before (pre-task) and after playing the game (post-task). Questionnaires assessing the frequencies of 10 digital work-related visual symptoms were conducted for both lens types at T1. RESULTS:Switching from SVL to PAL increased the working distance in both cohorts (mean ± SEM = 1.88 ± 0.60 cm; P = .002) and induced a small but significant positive refractive shift (+0.08 ± 0.04 D, P = .021) in the older cohort at T1. In the younger cohort, the changes in working distance due to the switching lens design were correlated with myopic error (r = +0.66, P = .002). In the older cohort, the changes in refractive shift due to switching lens design were correlated with amplitude of accommodation at both time points (r for T0 and T1 = -0.32 and -0.30, respectively; both P < .05). Progressive addition lens was rated as causing less "increased sensitivity to light" compared with SVL. CONCLUSIONS:Switching from SVL to PAL increased the working distance and induced a positive refractive shift in the majority of pre-presbyopic adults.

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Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear.

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Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear.

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