According to the 2014 National Diabetes Statistics Report (1), 29.1 actor bodies in the United States (9.3% of the population) accept diabetes; 28.7% of adults >18 years of age use insulin abandoned or in aggregate with articulate medications (1). Nearly 35% of U.S. adults are obese, and this bulk has steadily added during the accomplished 20 years (2). With the growing cardinal of adults with diabetes and accretion ante of obesity, there is an added prevalence of insulin attrition and appropriately a charge for ample circadian doses of insulin for glycemic control.
U-500 accustomed (U-500R) insulin has been acclimated for decades but has acquired acceptance in the accomplished 10 years as a aftereffect of the admission in blubber and insulin resistance. The authority of U-500R insulin is bristles times greater than U-100 insulins; 1 mL of U-500R contains 500 units of insulin compared to 1 mL of accepted U-100 insulin, which contains 100 units. The concentrated U-500R is advantageous for patients who are acutely insulin resistant, acute ample doses of U-100 insulin because adapted insulin assimilation and arising can action aback ample volumes are injected, which reduces adeptness (3,4). To enhance U-100 insulin efficacy, practitioners generally breach the dosage aback the aggregate exceeds 40–60 units per dose. However, from the accommodating perspective, defective two injections to administrate a distinct dosage may be undesirable. For this reason, converting a accommodating acute aerial doses of insulin from U-100 to U-500R could be advised because this advantage would abatement aggregate by 80% while still carrying the adapted cardinal of units.
The pharmacokinetic characteristics of U-500R arise to abatement amid those of NPH insulin and U-100 accustomed insulin and acquiesce U-500R to accommodate both basal and mealtime insulin advantage (5). Because of its pharmacokinetic properties, delayed aiguille effect, and abiding continuance of action, U-500R can be dosed alert circadian (6). The bifold basal and mealtime advantage provides an advantage, abnormally aback patients crave aerial doses of basal insulin in accession to mealtime insulin.
The use of U-500R can abate the aggregate and cardinal of insulin doses required. For example, a accommodating who requires 90 units of basal insulin alert circadian and 30 units of rapid-acting or accustomed insulin three times circadian with anniversary meal would be injecting bristles doses of insulin daily. To enhance the absorption, the basal insulin dosage may be disconnected into two doses of 45 units, but this would admission the cardinal of circadian injections to seven. The bang accountability may aftereffect in accommodating nonadherence. Furthermore, adherence may be abnormally afflicted by cost; the book categorical aloft would crave six vials of basal U-100 insulin, two vials of U-100 rapid-acting or accustomed insulin, and two 100-count boxes of syringes anniversary month. If the accommodating were transitioned to U-500R, in best cases, alone two circadian injections would be required, which would alter the abundant basal and mealtime insulin injections bare with U-100 insulin. Fewer circadian injections can additionally abate accommodating ache and lower the likelihood of developing lipodystrophy.
Although use of U-500R insulin has advantages, it is not afterwards challenges. The two better challenges are weight accretion and hypoglycemic events. Weight accretion may action if accommodating adherence to comestible and concrete action is not maintained. In one meta-analysis (7), the boilerplate bulk of weight accretion was 4.38 kg, although best patients’ weight appears to balance aural 6 months afterwards admission of U-500R insulin. In one abstraction (8), weight added by 3.2% at 3 months and by 1.6% at 12 months in patients who accomplished U-500R insulin. These after-effects were agnate to a abstraction by Lowery et al. (9), in which a 2% weight accretion was empiric with U-500R insulin (9).
The accident for hypoglycemic episodes is additionally agitated with the use of U-500R insulin because of its added potency, decreased abeyant for leakage, and bigger absorption. Based on a meta-analysis (9), astringent hypoglycemia was not appear to be a botheration and occurred at agnate ante to U-100 accustomed insulin. However, Dailey and Tannock (5) acclaimed that balmy hypoglycemia added hardly during the aboriginal few months, but again about beneath thereafter. The accident of hypoglycemia from U-500R insulin is abnormally apropos in patients who are nonadherent to provider instructions and who self-adjust their insulin independently.
Dosing errors are an added challenge. According to the U.S. Food and Drug Administering (FDA), the majority of errors with U-500R insulin action during prescribing, dosing, or administering (10). The FDA recommends that a about-face blueprint should consistently be acclimated aback administering doses from a U-500R canteen with a U-100 insulin syringe or 1-mL tuberculin syringe if specific U-500R syringes are not available. The assigned dosage of U-500R insulin should consistently be bidding in absolute units of U-500R, forth with agnate arrangement on the syringe the accommodating is using. This is because artful the dosage of U-500R can be ambagious to some practitioners because dosing requires about-face to volume. Similarly, because patients on insulin are acclimated to administering doses in units and not in milliliters, cartoon up an authentic dosage of U-500R can be confusing. In either situation, a dosing or dispensing absurdity could aftereffect in a fivefold accidental balance or underdose, and a fivefold balance could be baleful (11).
To abode the affair of dosing errors, two new developments accept emerged. A U-500–specific insulin syringe has been advised by Becton Dickinson and accustomed by the FDA with bartering availability in November 2016. The new syringe is 0.5 mL with adventurous U-500 arrangement in 5-unit increments and allows for dosing up to 250 units. It has a 6 mL × 31 barometer needle, which is the beeline insulin syringe aggravate accessible and is advised to abbreviate the accident of intramuscular bang (12). In 2016, the FDA accustomed the U-500R KwikPen by Eli Lilly. This pen dials and doses U-500R insulin up to 300 units per dosage and eliminates about-face and dosing errors (13). The pen is acceptable and accessible to use but may be cost-prohibitive, abnormally for underserved populations who are uninsured or on government bloom affliction programs.
To enhance the safe and adapted use of U-500R insulin in the outpatient analytic setting, a dosing acceding and a patient-provider U-500R insulin acceding should be considered. Here, we acquaint a U-500R Insulin Affairs that includes a dosing and titration protocol, as able-bodied as an acceding amid accommodating and providers at a federally able bloom centermost (FQHC).
Sheridan Bloom Services, an FQHC affiliated with the University of Colorado College of Nursing in Aurora, serves as a analytic adroitness convenance armpit and adjustment armpit for a array of bloom affliction able students. The dispensary provides primary care, including women’s health, dental care, behavioral health, and analytic pharmacy casework in an integrated, interprofessional affliction model. The dispensary provides admission to a blueprint of decree and nonprescription drugs, including insulin, for uninsured patients. Added than bisected of all patients (54%) are insured through Medicaid, and >27% adopt to acquaint in Spanish.
The U-500R Insulin Affairs was developed and accomplished for adapted patients acute >200 units/day of insulin. Patients who were adherent with medications and dispensary visits, had no or basal cerebral impairment, were able to admit hypoglycemia, and were accommodating to accept account contiguous or buzz consultations with analytic pharmacy casework were acceptable for the program. It is acute for patients on insulin, and abnormally U-500R insulin, to accept advantageous affairs behaviors such as actuality physically alive and authoritative advantageous meal choices; accept the risk, prevention, and analysis of hypoglycemia; and attach to their doses afterwards self-adjustment.
At the time the affairs was initiated, the analytic pharmacist, certified diabetes drillmaster (CDE), and dispensary providers collaboratively developed a U-500R insulin dosing protocol. This acceding was advised to accommodate a action for converting patients from U-100 to U-500R insulin and titrating doses of U-500R insulin (Table 1). Afterwards accomplishing of the U-500R protocol, it became credible that assurance can be compromised aback patients do not attach to aftereffect visits or comestible and exercise regimens. For this reason, a patient-provider acceding was developed by the analytic pharmacist and CDE. This acceding was advised to animate accommodating adherence with medications and assigned regimens for monitoring, diet, exercise, and dispensary visits to ensure all-embracing accommodating assurance (Figure 1). The certificate was advised by the providers to access ascribe afore implementation.
Sheridan Bloom Services’ U-500R Insulin Administration Protocol
Sheridan Bloom Casework U-500 insulin patient-provider agreement.
During patients’ aboriginal visit, a accommodating appraisal is completed and documented. The appointment includes about-face of U-100 insulin to U-500R insulin, appraisal of the patient’s adeptness to analyze hypoglycemic events, altercation of hypoglycemia management, accretion of the accent of claret glucose monitoring/scheduling, and appraisal of accepted comestible habits and akin of concrete activity. Patients are accomplished about the expectations of acceptance into the affairs and asked to assurance the patient-provider U-500R insulin agreement. Afterwards patients accede to attach to expectations in the program, the U-500R insulin acceding is initiated, and U-100 insulins are discontinued. Again accommodating compassionate is verified, and SMART (Specific, Measureable, Actionable, Attainable, Realistic, Timely, and Time-Bound) goals are established. The accommodating charge authenticate the able action for cartoon up the authentic bulk of U-500R insulin, accurately call aback claret glucose testing will occur, and accurately call how hypoglycemia will be managed should it occur. Patients charge accede to account aftereffect via buzz or contiguous visits.
Subsequent visits or buzz calls with patients action every 1–2 weeks and focus on reviewing the items discussed at the aboriginal appointment and titrating insulin per protocol, as adumbrated by boilerplate claret glucose values. If there is aberration from or affirmation of nonadherence to the expectations categorical in the patient-provider agreement, the acceding is reviewed. At this time, patients are notified that, if they do not accept by the agreement, their U-500R insulin will be discontinued, and they will be transitioned aback to U-100 insulins.
Three case examples allegorize the account of the U-500R Insulin Program, which congenital the use of an insulin dosing and titration acceding and a patient-provider agreement. All three cases circuitous patients with diabetes who adapted ample doses of insulin. Of the three patients switched to U-500R insulin, all had bigger glycemic control. One, whose A1C ambition was 8% due to age and comorbidities, had an A1C abridgement from 9.2 to 6.9%, which resulted in a abridgement of the U-500R insulin dose. The added two patients anniversary had an A1C ambition of 7%; one had a abridgement from 10.4 to 8.1%, and the added had a abridgement from 10.5 to 7.8% afore actuality titrated off of U-500R insulin and transitioned aback to U-100 in beforehand of a appointed bariatric anaplasty procedure. All three patients had cogent weight accretion of 3–6% afterwards initiating U-500R insulin, with an boilerplate 10-lb weight accretion aural the aboriginal 2 months afterwards starting U-500R insulin. However, with the admission of the patient-provider agreement, patients’ weight counterbalanced aural 3–4 months. One accommodating had hypoglycemic contest on an advancing basis, primarily due to affairs and bistro habits. Both issues authenticate the accent of common and constant advice with patients on U-500R insulin, accommodating adherence to affairs modification, and the development of patient-centered goals for diabetes care.
Development of a specialized acceding and accommodating acceding was an able action for managing circuitous patients aback application a collaborative access to aggrandize the ambit of primary affliction to a role commonly agitated out by specialty care.
The U-500R Insulin Affairs was developed for the few patients who were acutely insulin aggressive and whose diabetes was not controlled on ample doses of U-100 insulin. Initially, alone the U-500R insulin dosing acceding was developed and implemented. The acceding was acknowledged in abbreviating patients’ claret glucose ethics and A1C compared to U-100 insulins. On average, A1C decreased by 2.3–2.7%, with an boilerplate abridgement of 2.4% afterwards about-face from U-100 insulins to U-500R insulin. This A1C abridgement empiric with this affairs was added than what has been approved in the literature. In a abstraction by Eby et al. (14), it was appear that beggarly A1C in 445 patients on U-500R insulin decreased by 0.68% (P <0.0001 compared with baseline A1C) (14).
Furthermore, the patients in this affairs accomplished added weight accretion than what was expected. The three archetype patients who were adapted to U-500R acquired an added 3–6% anatomy weight, which was agnate to the weight accretion empiric in antecedent studies (7–9). Based on accommodating appointment data, it was articular that adherence to diet and exercise was lacking, and this was anticipation to accept contributed to patients’ weight gain.
The abstraction by Eby et al. (14) additionally acclaimed that the admeasurement of patients accepting hypoglycemic events, captured primarily in outpatient settings, added from 6.7 to 11.9% (P <0.0001). Eby et al. appear that these contest additionally added from 0.23 to 0.39 incidents per accommodating per year, which was an admission of 0.13% (P = 0.003). Although the accommodating in one of our archetype cases declared aloft was experiencing hypoglycemic episodes, it was bent that he was not bistro consistently or adhering to his assigned agenda for meal timing.
The accomplishing of a U-500R Insulin Affairs that included an insulin dosing and titration acceding and a patient-provider acceding helped to ensure the safe and able use of U-500R insulin in a baby sample of patients in an FQHC. The acceding aided the safe admission and adapted titration of U-500R insulin. With the use of U-500R insulin, all patients in the affairs approved an advance in diabetes control, as adumbrated by reductions in A1C. Although weight accretion and hypoglycemia occurred, they were beneath afterwards accomplishing of a patient-provider agreement.
No abeyant conflicts of absorption accordant to this commodity were reported.
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