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 prominent role in injection technique improvement. The aim was to assess the ability of structured education to reduce (i) GV and hypos, (ii) HbA1c levels, (iii) insulin daily doses, and (iv) overall healthcare-related costs in outpatients with T2DM who were erroneously injecting insulin into LH.

Methods: 318 patients aged 19-75 years who had been diagnosed with T2DM for at least 5 years, were being treated with insulin, were routinely followed by a private network of healthcare centers, and who had easily seen and palpable LH nodules were included in the study. At the beginning of the 6-month run-in period (T-6), all patients were trained to perform structured self-monitoring of blood glucose and to monitor symptomatic and severe hypos (SyHs and SeHs, respectively). After that (at T0), the patients were randomly and equally divided into an intervention group who received appropriate IT education (IG) and a control group (CG), and were followed up for six months (until T+6). Healthcare cost calculations (including resource utilization, loss of productivity, and more) were carried out based on the average NHS reimbursement price list.

Results: Baseline characteristics were the same for both groups. During follow-up, the intra-LH injection rate for the CG progressively decreased to 59.9% (p < 0.001), a much smaller decrease than seen for the IG (1.9%, p < 0.001). Only the IG presented significant decreases in HbA1c (8.2 ± 1.2% vs. 6.2 ± 0.9%; p < 0.01), GV (247 ± 61 mg/dl vs. 142 ± 31 mg/dl; p < 0.01), insulin requirement (- 20.7%, p < 0.001), and SeH and SyH prevalence (which dropped dramatically from 16.4 to 0.6% and from 83.7 to 7.6%, respectively; p < 0.001). In the IG group only, costs-including those due to the reduced insulin requirement-decreased significantly, especially those relating to SeHs and SyHs, which dropped to €25.8 and €602.5, respectively (p < 0.001).

Conclusion: Within a 6-month observation period, intensive structured education yielded consistently improved metabolic results and led to sharp decreases in the hypo rate and the insulin requirement. These improvements resulted in a parallel drop in overall healthcare costs, representing a tremendous economic advantage for the NHS. These positive results should encourage institutions to resolve the apparently intractable problem of LH by financially incentivizing healthcare teams to provide patients with intensive structured education on proper injection technique.

Trial registration: Trial registration no. 118/15.04.2018, approved by the Scientific and Ethics Committee of Campania University "Luigi Vanvitelli," Naples, Italy, and by the institutional review board (IRB Min. no. 9926 dated 05.05.2018).

Keywords: Diabetes; Direct and indirect costs; Education; Glycemic variability; Hypoglycemia; Lipohypertrophy.

Fig. 1

Flow chart depicting the enrollment procedure for patients who had already been screened for LH lesions during a previous study [31]. LH lipohypertrophy

Fig. 2

Schematic of the study protocol. KP KwikPen, Hypos hypoglycemic episodes, GV glycemic variability, CG control group, IG intervention group, SMBG self-monitoring of blood glucose

Fig. 3

Mean ± SD values of HbA1c in the control group (CG) and the intervention group (IG) at T0 and T+6, and significance of the observed differences. *p < 0.01 vs. IG T0; °p < 0.01 vs. CG T0, and CG T+6

Fig. 4

Mean ± SD values of glycemic variability (mg/dl) in the control group (CG) and the intervention group (IG) at T0 and T+6, and significance of the observed differences. *p < 0.01 vs. IG T0; °p < 0.01 vs. CG T0, and CG T+6