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Optimizing Insulin Delivery in Patients With Diabetes Mellitus: Still Room for Improvement

      Although the transdermal or subcutaneous delivery of medicinal substances is a practice universally accepted in modern medicine, the medical literature suggests that this concept dates to only the 17th century.
      • Macht D.I.
      The history of intravenous and subcutaneous administration of drugs.
      In relatively more recent times, the physician Alexander Wood, working in the 1850s in Scotland, is credited with advancing the concept of delivering medications (particularly opioids) subcutaneously via a syringe fitted with a hollow needle.
      • Macht D.I.
      The history of intravenous and subcutaneous administration of drugs.
      Although syringes and needles are a routine fixture in nearly all aspects of medical practice today, it is likely that their single most common use is for the delivery of insulin, with insulin-dependent diabetic patients typically requiring from 1 to 4 insulin injections on a daily basis. Given the present necessity to deliver insulin subcutaneously, it is notable that the first syringe made specifically for insulin injection was manufactured in 1924.

      Becton, Dickinson and Company. 2015 Annual Report. Becton, Dickinson and Company website. http://www1.bd.com/ar15/annual-report-2015.pdf. Accessed July 21, 2016.

      From that date to the 1960s, there was little change in syringe or needle design or use. Thus, most insulin needles from that time frame were of a standard length, with syringes manufactured from reusable glass that required placement in boiling water before each use in order to promote aseptic technique. The first one-piece disposable insulin syringe was produced as recently as 1970.

      Becton, Dickinson and Company. 2015 Annual Report. Becton, Dickinson and Company website. http://www1.bd.com/ar15/annual-report-2015.pdf. Accessed July 21, 2016.

      Over the past several decades, there have been numerous recommendations, both published in the indexed literature and unpublished, regarding the optimal technique(s) for insulin injection. Most of these recommendations, however, have been provided as a matter of opinion, with actual best practices only infrequently studied. Given this relative disconnect, it is only more recently that there has been increased recognition of the importance of the technical aspects of insulin delivery and their possible relationship to glycemic control and care optimization in patients with diabetes.
      • Davidson J.A.
      New injection recommendations for patients with diabetes.
      • Bergenstal R.M.
      • Strock E.S.
      • Peremislov D.
      • Gibney M.A.
      • Parvu V.
      • Hirsch L.J.
      Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes.
      Indeed, for most patients, self-delivery of insulin may be the only time during which they are exposed to a syringe not directly held by a medical professional. Despite this fact, however, it is clear that many insulin-requiring diabetic patients are often woefully undereducated regarding the best practices for insulin delivery, a factor that frequently undermines their current and future health and increases their risks for diabetes-associated complications.
      It is in this context that 3 related articles authored by Frid et al
      • Frid A.H.
      • Hirsch L.J.
      • Menchior A.R.
      • Morel D.R.
      • Strauss K.W.
      Worldwide injection technique questionnaire study: population parameters and injection practices.
      • Frid A.H.
      • Hirsch L.J.
      • Menchior A.R.
      • Morel D.R.
      • Strauss K.W.
      Worldwide injection technique questionnaire study: injecting complications and role of the professional.
      • Frid A.H.
      • Kreugel G.
      • Grassi G.
      • et al.
      New insulin delivery recommendations.
      in the current issue of Mayo Clinic Proceedings address technical issues that, although often overlooked by practitioners who provide care to patients with diabetes, are of absolutely fundamental clinical importance for the optimal administration of insulin and ultimately for the care of these patients. Based on the supporting survey data described by the authors,
      • Frid A.H.
      • Hirsch L.J.
      • Menchior A.R.
      • Morel D.R.
      • Strauss K.W.
      Worldwide injection technique questionnaire study: population parameters and injection practices.
      • Frid A.H.
      • Hirsch L.J.
      • Menchior A.R.
      • Morel D.R.
      • Strauss K.W.
      Worldwide injection technique questionnaire study: injecting complications and role of the professional.
      provided by more than 13,000 insulin-injecting patients across 42 countries, it is unfortunately clear that major gaps in the optimal provision of insulin continue to exist since the last published recommendations on this topic.
      • Frid A.
      • Hirsch L.
      • Gaspar R.
      • et al.
      Scientific Advisory Board for the Third Injection Technique Workshop
      New injection recommendations for patients with diabetes.
      Based on their findings from this largest survey of insulin injection practices ever performed, the authors propose a well-structured, if lengthy, series of new insulin delivery recommendations
      • Frid A.H.
      • Kreugel G.
      • Grassi G.
      • et al.
      New insulin delivery recommendations.
      that specifically reflect summaries from 5 previous symposia, including most recently the Forum for Injection Techniques and Therapy: Expert Recommendations (FITTER) workshop in October 2015 and previous meetings held in 1997, 2000, 2009, and 2011.

      Forum for Injection Technique and Therapy Expert Recommendations, October 23-25, 2015. http://www.fitter4diabetes.com/. Accessed July 21, 2016.

      Collectively, the 3 articles included in this issue of the Proceedings are unique and provide a valuable state-of-the-art reference guide for care standards related to insulin injections. Key points from the current recommendations include the importance of (1) needle length, (2) consistent adherence to the correct injection process, (3) avoidance of intramuscular injections, (4) routine injection site rotation and avoidance of injections into areas with evidence of lipohypertrophy, (5) addressing potential psychological barriers to insulin therapy before initiation, and (6) proper disposal of used needles and lancets. Accordingly, the widespread adoption and implementation of these recommendations should be of particular interest to all practitioners who provide care to diabetic patients treated with insulin injections.
      Like many of the best guidelines, however, the devil lies not in the recommendations themselves—which in this case are concise, practical, and readily distilled within the “Golden Rules” section in the appendix of the new insulin delivery recommendations
      • Frid A.H.
      • Kreugel G.
      • Grassi G.
      • et al.
      New insulin delivery recommendations.
      —but rather in their widespread implementation by patients and health care teams. Likely barriers to implementation include a lack of time for health care team members to provide individualized counseling, as well as a lack of perceived importance (by both health care professionals and patients) regarding the necessity of optimal insulin injection technique as a fundamental driver of glycemic control. These potential barriers exist despite the evolution of insulins, insulin analogues, and insulin delivery techniques over the past several decades, with previous recommendations regarding best practices having been perceived as complicated and at times inconvenient for both patients and health care professionals.
      • Fleming D.R.
      • Jacober S.J.
      • Vandenberg M.A.
      • Fitzgerald J.T.
      • Grunberger G.
      The safety of injecting insulin through clothing.
      From that perspective, these new insulin delivery recommendations should be considered afresh. Whereas many previous recommendations have lacked scientific underpinnings and were instead based on face validity and opinion, the authors of these new recommendations are to be commended both for their completeness and for the provision of clarity to a dauntingly large task. To this end, the authors have provided detailed and extensively annotated supplementary supportive data that have been previously reviewed by “183 diabetes experts from 54 countries.” Consistent with the importance of this topic, these new recommendations are largely supportive of those of the American Association of Diabetes Educators, the multidisciplinary organization dedicated to optimizing health and quality of life in patients with diabetes, which also emphasize the importance of optimal methods for insulin delivery as part of their published recommendations and curriculum.

      American Association of Diabetes Educators. Strategies for Insulin Injection Therapy in Diabetes Self-Managmeent. https://www.diabeteseducator.org/docs/default-source/legacy-docs/_resources/pdf/research/aade_meded.pdf?sfvrsn=2. Published 2011. Accessed July 21, 2016.

      It is also critically important to bear in mind that optimal implementation of the aforementioned recommendations will require that health care professionals use plain language when communicating with patients (and their helpers) and data-driven logistics in order to achieve the best patient outcomes. This effort will necessarily add to an already complex set of patient self-care behaviors. Fundamental questions include whether patients will understand concepts such as lipohypertrophy, lipoatrophy, or descriptions such as “inject at 90 degrees.” Further, although organization of the recommendations by major systems (eg, anatomy, physiology, pathology, psychology, and technology) appears to be an intuitive approach for the health care professional, there remains a need to validate the utility of this approach for improving patients' understanding, guideline compliance, and outcomes. Perhaps even more important will be the need to both identify and understand current patient behaviors that have not been addressed by the recommendations, such as the importance of timing for insulin delivery and the expected pharmacological responses to a seemingly ever increasingly complex array of insulins and insulin analogues. As with other complex medical behaviors similar to insulin administration, the development of a checklist, such as that currently available through the American Association of Diabetes Educators, may be one such approach for facilitating both patient and health educator awareness and may likewise assist in recommendation implementation.
      Thus, while progress has been and continues to be made, it is clear that there remains considerable room for improvement for the optimization of insulin delivery practices in patients with diabetes. In this regard, it is certain that further studies will be necessary to determine the best implementation practices and clinical tools for this aspect of diabetes self-management. Future research may need to focus on the identification of the best or preferred insulin injection sites and/or factors that specifically influence or reduce pain at sites of injection. Finally, as technology continues to evolve, updated recommendations with an emphasis on alternative insulin delivery methods such as continuous subcutaneous insulin delivery (insulin pumps), inhaled insulin, and other novel methods will require development.

      References

        • Macht D.I.
        The history of intravenous and subcutaneous administration of drugs.
        JAMA. 1916; LXVI: 856-860
      1. Becton, Dickinson and Company. 2015 Annual Report. Becton, Dickinson and Company website. http://www1.bd.com/ar15/annual-report-2015.pdf. Accessed July 21, 2016.

        • Davidson J.A.
        New injection recommendations for patients with diabetes.
        Diabetes Metab. 2010; 36 ([editorial]): S2
        • Bergenstal R.M.
        • Strock E.S.
        • Peremislov D.
        • Gibney M.A.
        • Parvu V.
        • Hirsch L.J.
        Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes.
        Mayo Clin Proc. 2015; 90: 329-338
        • Frid A.H.
        • Hirsch L.J.
        • Menchior A.R.
        • Morel D.R.
        • Strauss K.W.
        Worldwide injection technique questionnaire study: population parameters and injection practices.
        Mayo Clin Proc. 2016; 91: 1212-1223
        • Frid A.H.
        • Hirsch L.J.
        • Menchior A.R.
        • Morel D.R.
        • Strauss K.W.
        Worldwide injection technique questionnaire study: injecting complications and role of the professional.
        Mayo Clin Proc. 2016; 91: 1224-1230
        • Frid A.H.
        • Kreugel G.
        • Grassi G.
        • et al.
        New insulin delivery recommendations.
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        • Frid A.
        • Hirsch L.
        • Gaspar R.
        • et al.
        • Scientific Advisory Board for the Third Injection Technique Workshop
        New injection recommendations for patients with diabetes.
        Diabetes Metab. 2010; 36: S3-S18
      2. Forum for Injection Technique and Therapy Expert Recommendations, October 23-25, 2015. http://www.fitter4diabetes.com/. Accessed July 21, 2016.

        • Fleming D.R.
        • Jacober S.J.
        • Vandenberg M.A.
        • Fitzgerald J.T.
        • Grunberger G.
        The safety of injecting insulin through clothing.
        Diabetes Care. 1997; 20: 244-247
      3. American Association of Diabetes Educators. Strategies for Insulin Injection Therapy in Diabetes Self-Managmeent. https://www.diabeteseducator.org/docs/default-source/legacy-docs/_resources/pdf/research/aade_meded.pdf?sfvrsn=2. Published 2011. Accessed July 21, 2016.

      4. American Association of Diabetes Educators. Insulin Injection Know-How. https://www.diabeteseducator.org/docs/default-source/legacy-docs/_resources/pdf/general/Insulin_Injection_Educator_Assessment_AADE.pdf. Accessed July 21, 2016.

      Linked Article

      • New Insulin Delivery Recommendations
        Mayo Clinic ProceedingsVol. 91Issue 9
        • Preview
          Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015.
        • Full-Text
        • PDF
        Open Access
      • Worldwide Injection Technique Questionnaire Study: Population Parameters and Injection Practices
        Mayo Clinic ProceedingsVol. 91Issue 9
        • Preview
          From February 1, 2014, through June 30, 2015, 13,289 insulin-injecting patients from 423 centers in 42 countries took part in one of the largest surveys ever performed in diabetes. The goal was to assess patient characteristics, as well as historical and practical aspects of their injection technique. Results show that 4- and 8-mm needle lengths are each used by nearly 30% of patients and 5- and 6-mm needles each by approximately 20%. Higher consumption of insulin (as measured by total daily dose) is associated with having lipohypertrophy (LH), injecting into LH, leakage from the injection site, and failing to reconstitute cloudy insulin.
        • Full-Text
        • PDF
        Open Access
      • Worldwide Injection Technique Questionnaire Study: Injecting Complications and the Role of the Professional
        Mayo Clinic ProceedingsVol. 91Issue 9
        • Preview
          From February 1, 2014, through June 30, 2015, 13,289 insulin-injecting patients from 423 centers in 42 countries participated in one of the largest surveys ever performed in diabetes. The first results of this survey are published elsewhere in this issue. Herein we report that the most common complication of injecting insulin is lipohypertrophy (LH), which was self-reported by 29.0% of patients and found by physical examination in 30.8% by health care professionals (HCPs). Patients with LH consumed a mean of 10.1 IU more insulin daily than patients without LH.
        • Full-Text
        • PDF
        Open Access