title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Medical Psychology, VU University Medical Centre (VUMC), Amsterdam, the Netherlands. t.hajos@vumc.nl
authors.forename: T R S
authors.initials: TR
authors.lastname: Hajos
authors.forename: F
authors.initials: F
authors.lastname: Pouwer
authors.forename: R
authors.initials: R
authors.lastname: de Grooth
authors.forename: F
authors.initials: F
authors.lastname: Holleman
authors.forename: J W R
authors.initials: JW
authors.lastname: Twisk
authors.forename: M
authors.initials: M
authors.lastname: Diamant
authors.forename: F J
authors.initials: FJ
authors.lastname: Snoek
mesh_terms: D001786:Blood Glucose / Q000187:drug effects*; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000592:standards; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting