Use of Continuous Glucose Monitors Upon Hospital Discharge of People With Diabetes: Promise, Barriers, and Opportunity.

Continuous glucose monitors (CGMs) have increasingly been used in ambulatory and inpatient or hospital settings to improve glycemic outcomes for people with diabetes. Given their capacity to aid individuals in avoiding hypo- and hyperglycemia, they may also be useful when transitioning from hospital to home by reducing rates of hospital readmissions and emergency department visits. Several types of barriers presently exist that make the deployment of CGMs at the time of hospital discharge problematic, including (1) regulatory, (2) behavioral, (3) logistical, (4) technical, (5) staffing, and (6) systemic issues. In this commentary, we review the literature, discuss these barriers, and propose possible solutions to facilitate the use of CGMs in people with diabetes at the time of hospital discharge.

Analysis of "Dose Accuracy, Injection Force, and Usability Assessment of a New Half-Unit, Prefilled Insulin Pen".

Half-unit insulin pens (HUPs) offer finer gradation of insulin dosing than their integer-unit counterparts, tackling the inaccuracies of dose rounding that make it difficult for insulin-sensitive populations to achieve tight glycemic control. This article analyzes the first prefilled HUP, the Humalog Junior KwikPen, in the context of other, similar devices and the developing landscape of smart insulin pens. The Junior KwikPen's suitability for pediatric patients is assessed in reference to a recent study surveying its accuracy and usability under varying conditions intended to simulate real-world use.

Half-Unit Insulin Pens: Disease Management in Patients With Diabetes Who Are Sensitive to Insulin.

BACKGROUND: Insulin pens represent a significant technological advancement in diabetes management. While the vast majority have been designed with 1U-dosing increments, improved accuracy and precision facilitated by half-unit increments may be particularly significant in specific patients who are sensitive to insulin. These include patients with low insulin requirements and in those requiring more precise dose adjustments, such as the pediatric patient population. This review summarized functional characteristics of insulin half-unit pens (HUPs) and their effect on user experience. METHODS: The literature search was restricted to articles published in English between January 1, 2000, and January 1, 2015. A total of 17 publications met the set criteria and were included in the review. RESULTS: Overall, studies outlined characteristics for 4 insulin HUPs. Based on their functionality, the pens were generally similar and all met the ISO 11608-1 criteria for accuracy. However, some had specific advantageous features in terms of size, weight, design, dialing torque, and injection force. Although limited, the currently available user preference studies in children and adolescents with diabetes and their carers suggest that the selection of an HUP is likely to be influenced by a combination of factors such as these, in addition to the prescribed insulin and dosing regimen. CONCLUSIONS: Insulin HUPs are likely to be a key diabetes management tool for patients who are sensitive to insulin; specific pen features may further advance diabetes management in these populations.

Accuracy and Injection Force of the Gla-300 Injection Device Compared With Other Commercialized Disposable Insulin Pens.

BACKGROUND: To deliver insulin glargine 300 U/mL (Gla-300), the widely used SoloSTAR(®) pen has been modified to allow for accurate and precise delivery of required insulin units in one-third of the volume compared with insulin glargine 100 U/mL, while improving usability. Here we compare the accuracy and injection force of 3 disposable insulin pens: Gla-300 SoloSTAR(®), FlexPen(®), and KwikPen™. METHODS: For the accuracy assessment, 60 of each of the 3 tested devices were used for the delivery of 3 different doses (1 U, half-maximal dose, and maximal dose), which were measured gravimetrically. For the injection force assessment, 20 pens of each of the 3 types were tested twice at half-maximal and once at maximal dose, at an injection speed of 6 U/s. RESULTS: All tested pens met the International Organization for Standardization (ISO) requirements for dosing accuracy, with Gla-300 SoloSTAR showing the lowest between-dose variation (greatest reproducibility) at all dose levels. Mean injection force was significantly lower for Gla-300 SoloSTAR than for the other 2 pens at both half maximal and maximal doses (P < .0271). CONCLUSION: All tested pens were accurate according to ISO criteria, and the Gla-300 SoloSTAR pen displayed the greatest reproducibility and lowest injection force of any of the 3 tested devices.

Functional Evaluation of the Reusable JuniorSTAR® Half-Unit Insulin Pen.

BACKGROUND: The functional performance of the JuniorSTAR(®) (Sanofi, Paris, France) half-unit insulin pen was evaluated through a series of specific objective tests to assess the dose accuracy, pen weight, injection force, and dialing torque. METHOD: Pens (n = 60) were tested under standard atmospheric conditions with 3 different types of insulins manufactured by Sanofi (insulin glargine, insulin glulisine, and biphasic insulin isophane). The dose accuracy was tested according to the ISO 11608-1:2012 standards. Injection doses of 0.010, 0.155, and 0.300 ml were evaluated. For mean weight evaluation, the pens without the cartridge were weighed on precision balances. The injection force was measured using a texture analyzer and the dialing torque was measured using a torque meter. RESULTS: JuniorSTAR met the ISO 11608-1:2012 criteria for dose accuracy as all the delivered doses were within the predefined limits for all types of insulin tested. The mean weight of the JuniorSTAR pen was 33.4 g (SD = 0.075). The mean injection force was 6.0 N (SD = 0.8), 4.3 N (SD = 0.4), and 5.1 N (SD = 0.6) for insulin glargine, insulin glulisine, and biphasic insulin isophane, respectively. The mean dialing torque was 5.09 Ncm (SD = 0.29) and 5.88 Ncm (SD = 0.53) for setting and correcting a dose, respectively. CONCLUSIONS: Together with results from a previously reported usability survey, these results show that the JuniorSTAR reusable, half-unit pen is a lightweight and accurate device for insulin delivery with a dialing torque and injection force suitable for young people with type 1 diabetes.

Improved pharmacokinetic and pharmacodynamic profiles of insulin analogues using InsuPatch, a local heating device.

BACKGROUND: Previous studies have shown that heating the insulin injection site may accelerate insulin absorption. We investigated the pharmacological profile of insulin administered with InsuPatch, a local skin-heating device. METHODS: In this randomized, crossover study carried out in 56 subjects with type 1 diabetes treated with insulin pump [mean age 32 ± 13.5 years; 23 women; HbA1c :7.8 ± 0.9% (62 ± 10 mmol/mol) (mean+/-standard deviation)]. Euglycemic glucose clamps were performed after administration of 0.15 units/kg of short-acting insulin analogues. Each subject underwent three clamp procedures: two with the InsuPatch device (day 1 and day 3) and one without the device (day 1 control). The primary endpoints were the following: (1) the change in the area under the curve (AUC) of insulin during the first 60 min post-insulin bolus on day 1 with the InsuPatch device versus day 1 control and (2) parameters to assess the safety of using the device. RESULTS: The area under the curve of insulin during the initial 60 min (insulin AUC(0-60)) after insulin bolus was increased by 29.7 ± 7% on day 1 InsuPatch versus day 1 control (p < 0.01). Maximal post-insulin bolus concentration was 57 mU/L on day 1 InsuPatch versus 47.6 mU/L on day 1 control (p < 0.01). On day 3 InsuPatch, insulin AUC(0-60) was increased by 27.9 ± 72% versus day 1 InsuPatch (p < 0.01). Maximal insulin concentration was 70.4 mU/L versus 57 mU/L, respectively (p = 0.05). CONCLUSIONS: The use of the heating device upon administration of short-acting insulin analogues in pump-treated type 1 diabetic patients was found to enhance insulin absorption. This heating device may therefore serve to achieve better meal insulin coverage.

Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals.

OBJECTIVES: The primary objective of this study was to investigate the dosing accuracy of the new prefilled FlexTouch insulin pen (FT) in comparison to conventional vial and syringe (V&S) when used by patients (Pts), caregivers (CG) and healthcare professionals (HCPs). METHODS: A total of 120 subjects participated in the trial (40 diabetes patients aged 61 ± 11 [mean ± SD] yrs, 20 caregivers [parents and other relatives], 20 physicians, and 40 nurses/certified diabetes educators). The participants were introduced to the devices in randomized order and were asked to perform injections of 5, 25, 43 and 79 IU doses into laboratory tubes. Dosing accuracy was analyzed by weighing the tubes on a pharmaceutical balance and calculating the mean absolute deviation (MAD) from the intended doses. After completing a device assessment questionnaire, Patient Perception Questionnaire (PPQ), with questions regarding device design and performance, the procedure was repeated for the other device, and the patients were finally asked to complete a device preference questionnaire (DPQ). RESULTS: Dosing accuracy was significantly better for FT when used by any of the cohorts at all doses. (MAD ± SD for FT/V&S; 5 IU: 0.4 ± 0.4/0.6 ± 0.6 IU; 25 IU: 0.3 ± 0.4/0.7 ± 0.9 IU; 43 IU: 0.4 ± 0.4/0.9 ± 1.2 IU; 79 IU: 0.5 ± 0.5/1.7 ± 1.6 IU, p < 0.005 for all doses). Dosing accuracy with FT for all three subgroups was comparable (patients: 0.35-0.59 IU; HCP&CG: 0.29-0.54 IU; n.s.). Dosing accuracy with V&S for all three subgroups was not comparable: HCP and CG performed much better with V&S than patients and delivered the doses with significantly higher accuracy (range of mean MAD; patients: 0.81-2.54 IU; HCP&CG: 0.51-1.30 IU, p < 0.005 at all doses). FT was ranked superior to V&S for all aspects of the PPQ. In the DPQ, 93% of the patients voted for FT (neutral: 5%, V&S: 2%), (CG: 100%/0%/0%; HCPs: 85%/2%/13%; p < 0.001 in all cases). CONCLUSION: FT, compared to V&S, was more accurate at all tested doses and was used with similar accuracy by patients, HCPs, and CGs. Using questionnaires only, and without dexterity assessment, study participants rated FT higher than V&S in every component of the PPQ and the vast majority of them preferred FT. These findings may point to a better alternative for dosing accuracy and improved adherence when using the new prefilled insulin pen compared to V&S for insulin delivery in patients with diabetes.

Evaluation of the JuniorSTAR® Half-unit Insulin Pen in Young People with Type 1 Diabetes - User Perspectives.

This paper discusses the results of a survey on the usability of a new half-unit insulin pen, JuniorSTAR® (CE mark pending, under the responsibility of Haselmeier), in children with type 1 diabetes. Insulin pen devices have advantages over the traditional vial-and-syringe method of insulin delivery, including improved patient satisfaction and adherence, greater ease of use and superior accuracy, especially when delivering small doses of insulin. The accuracy and design of insulin pens is particularly important in the paediatric population. Young children often require half-unit adjustments. As the incidence of type 1 diabetes is expected to increase in the coming years in children less than 5 years old, a higher use of half-unit dosing pens may be anticipated. A survey with JuniorSTAR half-unit insulin pen has shown that it is easy to use, read, carry and dial back. This was confirmed by patients and also by nurses. In conclusion, the JuniorSTAR half-unit pen is well suited to the lifestyle of young people with type 1 diabetes and could help them to gain autonomy to self-inject.