Compatibility of Insulin Lispro, Aspart, and Glulisine with the SoloTM MicroPump, a Novel Miniature Insulin Pump
نویسندگان
چکیده
Background: This study compared the stability of commercially available, rapid-acting insulin in the novel tubeless, skin-adhering SoloTM insulin pump over 6 days at extreme environmental conditions. Methods: Forty-eight pumps for each tested analog were loaded with three different insulin lots and operated at 30 U/day (three sets of 12 pumps) and 15 U/day (one set of 12 pumps) with basal/bolus delivery patterns for 6 days under extreme climatic (37°C, 40% relative humidity) and mechanical (35 strokes/min) stresses. The insulin solutions dispensed were sampled periodically and analyzed for potency, related substances, high molecular weight proteins (HMWP), and preservative content by high-performance liquid chromatography techniques. Biological activity (bioidentity) was demonstrated by an abrupt decrease in blood glucose in rabbits. Solutions were inspected for visual appearance and measured for pH levels. Results: During the 6-day sampling period, the potency of all insulin samples was maintained at 95.0–105.0% of the bulk solution concentration of the insulin vials. The levels of HMWP and related substances remained well below labeling limits. The preservative concentration decreased with time but remained bacteriostatic effective. Solutions maintained pH and clarity and were particulate free. The biological activity was verified. Conclusions: Insulin analogs lispro, aspart, and glulisine maintained physical, chemical, and biological properties for 6 days when used in the Solo MicroPump device. J Diabetes Sci Technol 2010;4(1):104-110 ORIGINAL ARTICLES
منابع مشابه
Compatibility of insulin Lispro, Aspart, and Glulisine with the Solo MicroPump, a novel miniature insulin pump.
BACKGROUND This study compared the stability of commercially available, rapid-acting insulin in the novel tubeless, skin-adhering Solo insulin pump over 6 days at extreme environmental conditions. METHODS Forty-eight pumps for each tested analog were loaded with three different insulin lots and operated at 30 U/day (three sets of 12 pumps) and 15 U/day (one set of 12 pumps) with basal/bolus d...
متن کاملContinuous subcutaneous insulin infusion in diabetes: patient populations, safety, efficacy, and pharmacoeconomics
The level of glycaemic control necessary to achieve optimal short-term and long-term outcomes in subjects with type 1 diabetes mellitus (T1DM) typically requires intensified insulin therapy using multiple daily injections or continuous subcutaneous insulin infusion. For continuous subcutaneous insulin infusion, the insulins of choice are the rapid-acting insulin analogues, insulin aspart, insul...
متن کاملLaboratory-based non-clinical comparison of occlusion rates using three rapid-acting insulin analogs in continuous subcutaneous insulin infusion catheters using low flow rates.
BACKGROUND Rapid-acting analog insulin is used increasingly for continuous subcutaneous insulin infusion therapy (CSII). As the choice of insulin may be a determinant of catheter occlusion, we compared rates of early and late occlusion of a standard CSII catheter with three insulin analogs in a laboratory-based setting. METHODS Twenty-four pumps were used for the study. Each insulin analog (g...
متن کاملClinical effects, cardiovascular and renal outcomes associated with rapid-acting insulin analogs among individuals with type 2 diabetes: a nation-wide observational cohort study
BACKGROUND Rapid-acting insulin analogs (RAIs) have not been examined for long-term safety in randomized clinical trials. We performed a nationwide longitudinal cohort study among individuals with type 2 diabetes (T2DM) to address cardiovascular safety and mortality among users of lispro, aspart and glulisine insulins. METHODS We used four national registers, following patients previously not...
متن کاملDetemir plus aspart and glulisine induced lipoatrophy: 2015 literature review and report of a new case
BACKGROUND In the first and only literature review, conducted in 2009, of human insulin analog- induced lipoatrophy, there were 12 published cases, including 1 with aspart, 1 with detemir, 1 with NovoMix 30 and none with detemir plus aspart. It is perceived that insulin analog induced-lipoatrophy is increasing. We conducted a 2015 literature review of published reports of lipoatrophy induced by...
متن کامل