Role of Structured Education in Reducing Lypodistrophy and its Metabolic Complications in Insulin-Treated People with Type 2 Diabetes: A Randomized Multicenter Case–Control Study

Abstract

Introduction: It is essential to use the correct injection technique (IT) to avoid skin complications such as lipohypertrophy (LH), local inflammation, bruising, and consequent repeated unexplained hypoglycemia episodes (hypos) as well as high HbA1c (glycated hemoglobin) levels, glycemic variability (GV), and insulin doses. Structured education plays a

The Durability of an Intensive, Structured Education-Based Rehabilitation Protocol for Best Insulin Injection Practice: The ISTERP-2 Study

“…By providing more education, HCPs could provide people suffering from a potentially disabling chronic disease with a valuable rehabilitation tool based on the systematic prevention of LHs and related complications [8,9]. These data indirectly explain why LHs are so frequent: according to the current literature, LHs affect 38% insulin-treated patients on average [10] and more than 60% of them in many cases [14]. Indeed, it must be admitted that healthcare systems worldwide are still characterized by their utmost attention to best drug regimen choices with total oblivion of systematic identification of skin lesions and suitable LH-prevention education [7].…”

“…All 158 randomized patients had participated in the ISTERP-1 and had received the educational training in that study according to exactly the same protocol that was provided to the intervention group in the present study. CG Control group, GV glycemic variability, HbA1c glycated hemoglobin, hypos hypoglycemic episodes, IG intervention group, pts patients, SMBG self-monitoring of blood glucose, T0 baseline, T1-T6 follow-up time points, US ultrasound Clinical LH identification criteria are reported elsewhere [6,8,14,16]. Procedures used for defining injection habits, through a structured questionnaire, and SMBG-based hypo occurrence and symptom severity identification have been described in detail for the ISTERP-1 study [14].…”

“…CG Control group, GV glycemic variability, HbA1c glycated hemoglobin, hypos hypoglycemic episodes, IG intervention group, pts patients, SMBG self-monitoring of blood glucose, T0 baseline, T1-T6 follow-up time points, US ultrasound Clinical LH identification criteria are reported elsewhere [6,8,14,16]. Procedures used for defining injection habits, through a structured questionnaire, and SMBG-based hypo occurrence and symptom severity identification have been described in detail for the ISTERP-1 study [14]. Adherence to the study protocol was defined as good when the subject provided [ 80% of expected recordings.…”

“…In addition, at T0, T?3, and T?6, all patients underwent a complete visit, including a careful examinination of the injection site, and completed a self-administered questionnaire based on a salient, nonintrusive, recent-past-oriented, well-established procedure developed as part of the original Worldwide Injection Technique Questionnaire Study 2016 [7,14,[16][17][18]. Highfrequency B-mode ultrasound skin scans were performed using the linear 20 MHz probe (HD3; Philips NV, Amsterdam, The Netherlands) at all injection sites, as previously described [8], to compare palpatory/pinching impressions with objective findings and to define LH features appropriately.…”

“…Significant changes in the absorption, pharmacokinetics, and pharmacodynamics of insulin can occur when insulin is injected into lipohypertrophic nodules, potentially leading to high glycated hemoglobin (HbA1c)) levels, glycemic variability, and changes in the daily insulin dose requirement [1][2][3][4][5][6][7]. Despite the risk factors for LH being very well known [6][7][8] and the publication of several papers on the rate of LH in different populations/care settings during the last few years [8][9][10], too little attention has been paid to LH prevention through education [11][12][13][14]. Even the few papers dealing with education on best insulin injection techniques suffer limitations as they are based on data from small case series or short-term observations.…”