Background: Verifying Insulin Strategy and Initial Health Outcome Analysis (VISION) was an 18-month observational study that explored treatment approaches in patients with T2DM initiating insulin in the MENA region. Aims: To summarise the demographic and clinical characteristics, patterns of insulin initiation and intensification, health care professional profile and patient-reported outcomes (PROs). Method: Patients aged ≥18 years with T2DM initiating insulin therapy in normal clinical course after oral drugs failure were enrolled from 4 MENA countries. A total of 1192 patients were enrolled from Egypt (n=645), Saudi Arabia (n=288), Algeria (n=181) and UAE (n=78). Participant data were recorded by the treating physicians and PROs were assessed using questionnaires. Results: Mean age of patients was 53.5 years with mean 9.9% HbA1c at baseline. Baseline HbA1c was high (>9%) in 55.5% of patients, despite 75.4% being on 2 or more oral anti-diabetic (OAD) agents, indicating a significant delay in insulin initiation. Dyslipidaemia and hypertension were the most frequent comorbidities in 43.5% and 42.9% of patients, respectively. 66.4% of patients were being followed by endocrinologist and the rest by non-endocrinologists. Basal insulin was initiated in 50.5% and premixed insulin in 46.3% of patients in overall MENA population. Majority of patients in Saudi Arabia (87.1%), Algeria (71.8%) and UAE (69.2%) received basal insulin whereas 71.7% of patients in Egypt received premixed insulin as initial insulin regimen. Sulfonylureas (79.7%) and metformin (79.2%) were the most commonly used oral medications at baseline, followed by DPP-4i in 23.5% of patients. A higher proportion of patients initiating basal insulin continued their oral medications compared to those initiating premixed insulin: metformin (67% vs 56.7%), SUs (50.4% vs 6.7%) and DPP-4i (21.4% vs 3.3%). Concomitant SU use was seen in 76.1% of patients on basal insulin as expected but SU was continued in 23.2% of patients on premixed, contrary to most international diabetes management guidelines (Table 1). Insulin treatment intensification (switching from basal to mealtime/premixed insulin, adding mealtime bolus doses and/or increasing the dosing frequency) was noted in 28.9% of patients initiated on basal insulin and 37.7% of patients initiated in premixed insulin. Among patients on initial basal insulin, 20.7% increased daily insulin dose, 11.1% had initial insulin regimen changed to mealtime or premixed, and new non-insulin medication was added for 7.8% of patients. Among patients on initial premixed insulin, 31.5% increased insulin dose, 5.6% had initial insulin regimen changed to basal or mealtime, and new non-insulin medication was added for 6.5% of patients. It was noteworthy that >60% of patients on either initial regimen were not intensified in their treatment over 18-month study and it appears to be the main reason, that about 59% of patients failed to achieve ≤7.5% HbA1c. Treatment perceptions and expectations changed in both initial basal and premixed insulin patient groups, who were continued on the same regimen for 18 months (difference Perceptions of Insulin Therapy Questionnaire [PITQ]-Expectations about Insulin Therapy Questionnaire [EITQ] scores; 4.45 vs 5.65, respectively). The mean Self-Efficacy Related to Insulin Therapy Questionnaire (SEITQ) scores changed from 25.1 (SD 5.1) at baseline (n=1158) and 27.7 (SD 4.9) at the end of study (n=752). Proportion of patients who were completely satisfied with their insulin treatment numerically changed from 5.5% to 17.5% in the first 6 months and remained stable until the end of the study. Discussion: VISION study highlights clinical inertia and importance of early insulin initiation and intensification. More than half of patients had an HbA1c >9% at the time of insulin initiation showing significant delay in insulin initiation and still only 41% of patients achieved ≤7.5% HbA1c after being on insulin for 18 months. It was noteworthy that a large proportion did not continue metformin with insulin which helps treating insulin resistance and is generally recommended whereas 23.2% of patients were continued on SU despite being on premixed insulin which is against most diabetes management guidelines. Insulin regimen change was more frequently needed in basal group, whereas premixed group needed more increase in insulin dose. Table 1: Usage of Oral Anti-Diabetic Agents (Baseline vs End of Study) Visits Initial insulin Metformin* Sulfonylureas* Thiazolidinediones * Meglitinides * DPP-4i* Basal (N=603) Baseline 91.0 83.9 6.8 4.8 34.2 End of Study 67.0 50.4 0.8 5.0 21.4 Premixed (N=552) Baseline 66.1 76.1 3.8 0.2 12.5 End of Study 43.3 23.2 0.7 0 5.6 *With/without other drugs.
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