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Franklin Lakes, NJ, United States

Saltiel-Berzin R.,BD Medical Diabetes Care
The Diabetes educator | Year: 2012

PURPOSE: Glucose variability leading to suboptimal glycemic control is common among people using injection therapies. Advanced technology and new studies have identified important issues related to injection technique: needle length and gauge, body mass index, skin and subcutaneous tissue thickness, adequate resuspension of cloudy insulins, leakage, choice of injection site and rotation, pinching a skinfold, and lipohypertrophy. All these issues can affect pain and bruising, insulin absorption, and blood glucose levels. The purpose of this article is to review current and past research regarding insulin injection therapy and to provide practical, translational information regarding injection technique, teaching/learning techniques specific to insulin administration, and implications for diabetes self-management education and support. CONCLUSION: International injection recommendations for patients with diabetes have recently been published and have identified specific recommendations for health care professionals. This article provides an evidence-based translational and practical review of the research regarding injection technique and teaching/learning theory. Diabetes educators need to reevaluate how they provide instruction for the administration of insulin and other injectable medications. Research regarding skin and subcutaneous thickness reveals that shorter needles may be appropriate for the majority of patients regardless of body mass index. Periodic reassessment of injection technique, including suspension of cloudy insulins and inspection of injection sites for lipohypertrophy, is a critical aspect of the role of the diabetes educator. An injection checklist is provided as a guide for diabetes educators.

McVey E.,BD Technologies | Hirsch L.,BD Medical Diabetes Care | Sutter D.E.,BD Technologies | Kapitza C.,Profil Institute fur Stoffwechselforschung GmbH | And 5 more authors.
Journal of Diabetes Science and Technology | Year: 2012

Background: Intradermal (ID) delivery has been shown to accelerate insulin pharmacokinetics (PK). We compared the PK and pharmacodynamic (PD) effects of insulin lispro administered before two daily standardized solid mixed meals (breakfast and lunch), using microneedle-based ID or traditional subcutaneous (SC) delivery. Method: The study included 22 subjects with type 1 diabetes in an eight-arm full crossover block design. One arm established each subject's optimal meal dose. In six additional arms, the optimal, higher, and lower doses (+30%, -30%) were each given ID and SC delivery, in random order. The final arm assessed earlier timing for the ID optimal dose (-12 versus -2 min). The PK/PD data were collected for 6 h following meals. Intravenous basal regular insulin was given throughout, and premeal blood glucose (BG) adjusted to 115 mg/dl. Results: The primary end point, postprandial time in range (70-180 mg/dl), showed no route-based differences with a high level of overall BG control for both SC and ID delivery. Secondary insulin PK end points showed more rapid ID availability versus SC across doses and meals (ΔTmax -16 min, ΔT50rising -7 min, ÄT50falling -30 min, all p < .05). Both intrasubject and intersubject variability for ID Tmax were significantly lower. Intradermal delivery showed modest, statistically significant secondary PD differences across doses and meals, generally within 90-120 min postprandially (Δ12 mg/dl BG at 90 min, Δ7 mg/dl BGmax, Δ7 mg/dl mean BG 0-2 h, all p < .05). Conclusions: This study indicates that ID insulin delivery is superior to SC delivery in speed of systemic availability and PK consistency and may improve postprandial glucose control. © Diabetes Technology Society.

Pettis R.J.,BD Technologies | Ginsberg B.,BD Medical Diabetes Care | Hirsch L.,BD Medical Diabetes Care | Sutter D.,BD Technologies | And 7 more authors.
Diabetes Technology and Therapeutics | Year: 2011

Background: This study compared insulin lispro (IL) pharmacokinetics (PK) and pharmacodynamics (PD) delivered via microneedle intradermal (ID) injection with subcutaneous (SC) injection under euglycemic glucose clamp conditions. Methods: Ten healthy male volunteers were administered 10 international units (IU) of IL at 3 microneedle lengths (1.25, 1.50, or 1.75 mm) in a randomized, crossover fashion on Days 1-3 followed by a repetitive ID 1.5-mm microneedle dose (Day 4) and an SC dose (Day 5). Results: Microneedle ID delivery resulted in more rapid absorption of IL, with decreased time to maximum insulin concentration (ID vs. SC: 36.0-46.4 vs. 64.3 min, P < 0.05) and higher fractional availability at early postinjection times. ID produced more rapid effects on glucose uptake with shorter times to maximal and early half-maximal glucose infusion rates (GIRs) (ID vs. SC: time to maximum GIR, 106-112 vs. 130 min, P < 0.05; early half-maximal GIR, 29-35 vs. 42 min), increased early GIR area under the curve (AUC), and faster offset of insulin action (shorter time to late half-maximal GIR: 271-287 vs. 309 min). Relative total insulin bioavailability (AUC to 360 min and AUC to infinite measurement) did not significantly differ between administration routes. ID PK/PD parameters showed some variation as a function of needle length. Delivery of ID IL was generally well tolerated, although transient, localized wheal formation and redness were observed at injection sites. Conclusions: Microneedle ID insulin lispro delivery enables more rapid onset and offset of metabolic effect than SC therapy and is safe and well tolerated; further study for insulin therapy is warranted. © Copyright 2011, Mary Ann Liebert, Inc.

Pettis R.J.,BD Technologies | Ginsberg B.,BD Medical Diabetes Care | Hirsch L.,BD Medical Diabetes Care | Kapitza C.,Profil Institute fur Stoffwechselforschung GmbH | And 6 more authors.
Diabetes Technology and Therapeutics | Year: 2011

Background: This study assessed pharmacokinetics (PK) and pharmacodynamic postprandial glycemia (PPG) in patients with type 1 diabetes mellitus (T1DM) after a standardized liquid meal following insulin lispro (IL) or regular human insulin (RHI) given by microneedle-based intradermal (ID) versus subcutaneous (SC) delivery. Research Design and Methods: In this randomized, open-label, five-way crossover study, 29 T1DM patients received IL and RHI (0.125 U/kg) at 2 min and 17 min premeal, respectively, by both the SC and ID routes and also received RHI by the ID route at 2 min premeal. Blood glucose was stabilized at 120 mg/dL prior to a standardized 82-g carbohydrate liquid meal. ID delivery used a 34-gauge 1.5-mm steel microneedle, and SC delivery used a 31-gauge 8-mm syringe needle. Results: The 90-min PPG (blood glucose area under the curve for 0-1.5 h) for ID RHI was 14% lower than SC RHI at -17 min (P < 0.0001) and 11% lower than ID RHI at -2 min (P=0.0006). PPG did not differ between ID RHI and SC IL, both at -2 min (P=0.8345). ID IL PPG was lower than SC, both at -2 min, but not significantly (P=0.10). Both ID IL and ID RHI PK data showed significantly faster uptake and time to maximum concentration, higher maximum concentration, and shorter systemic circulating duration versus SC dosing. ID IL and RHI delivery was generally well tolerated. Conclusions: PPG with RHI administered ID via microneedle was improved versus SC delivery when dosed 17 min premeal. ID RHI provided similar control of PPG as SC IL immediately premeal. Further studies of ID insulin delivery via steel microneedles are warranted. © Copyright 2011, Mary Ann Liebert, Inc.

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