Initiation of insulin glargine in patients with Type 2 diabetes in suboptimal glycaemic control positively impacts health-related quality of life. A prospective cohort study in primary care

Aims: To study prospectively the impact of initiating insulin glargine in suboptimally controlled insulin-naïve patients with Type 2 diabetes on health-related quality of life in relation to glycaemic control.

Methods: Insulin-naïve Dutch patients with Type 2 diabetes in suboptimal glycaemic control (HbA(1c) > 53 mmol/mol; 7%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Patients started insulin glargine and were followed up for 6 months. At baseline (start insulin therapy), 3 and 6 months, HbA(1c) was measured and patients completed self-report health-related quality of life measures, including emotional well-being (World Health Organization-5 well-being index), fear of hypoglycaemia (Hypoglycaemia Fear Survey) and diabetes symptom distress (Diabetes Symptom Checklist-revised). Data were analysed using generalized estimating equations analysis.

Results: HbA(1c) (mmol/mol; %) decreased from 69 ± 16; 8.5 ± 1.7 to 60 ± 11; 7.6 ± 1.0 and 57 ± 11; 7.3 ± 1.0 at 3 and 6 months, respectively (P < 0.001). Pre-insulin BMI (kg/m(2) ) was 30 ± 5.7, which remained stable at 3 months (30 ± 5.8) and increased to 31 ± 5.9 at 6 months (P = 0.004); no significant changes in self-reported symptomatic and severe hypoglycaemia were observed, while nocturnal hypoglycaemia slightly decreased. The Hypoglycaemia Fear Survey score decreased from 14.6 ± 16.2 to 12.1 ± 15.2 and 10.8 ± 14.4 at 3 and 6 months, respectively (P < 0.001). The Diabetes Symptom Checklist-revised score decreased from 15 ± 14 to 10 ± 12 and 10 ± 13 (P < 0.001), with most pronounced reductions in hyperglycaemic symptoms and fatigue. The World Health Organization-5 score increased from 57 ± 25.3 to 65 ± 21.6 at 3-month follow-up and 67 ± 21.8 at 6-month follow-up (P < 0.001).

Conclusions: Results of this observational study demonstrate combined glycaemic and health-related quality of life benefits of initiating insulin glargine in patients with Type 2 diabetes in routine primary care.