Glargine dose titration by patients and by physicians were equally effective for preventing severe hypoglycaemia
Q In patients with suboptimally controlled type 2 diabetes mellitus, is insulin glargine dose titration by a physician equivalent to titration by the patient for preventing severe hypoglycaemia and improving glycaemic control?
randomised controlled trial.
Follow up period:
611 centres in 59 countries in western and eastern Europe, South America, Asia, and Africa/Middle East.
5033 patients ⩾18 years of age (mean age 58 y, 52% women) who had suboptimally controlled type 2 diabetes mellitus (ie, required basal long acting insulin for control of hyperglycaemia), glycated haemoglobin [HbA1C] concentrations >7.0 and <12.0%, and body mass index <40 kg/m2. Exclusion criteria included impaired renal function and acute or chronic metabolic acidosis.
physician led dose titration of insulin glargine (n = 2529) or self managed dose adjustments (n = 2504). Patients in the physician managed group had their basal insulin dose adjusted weekly. In the self managed group, patients adjusted their basal insulin every 3 days, but these adjustments were reviewed by the investigator. Both algorithms had a target fasting blood glucose concentration of ⩽100 mg/dl (⩽5.5 mmol/l).
severe hypoglycaemia. Secondary outcomes included overall hypoglycaemia and glycaemic control (measured by HbA1c concentrations).
Patient follow up:
93% (intention to treat analysis).
The groups did not differ for rates of severe hypoglycaemia (table). The physician managed group had an overall lower rate of hypoglycaemia (30% v 33%, p<0.01) but poorer glycaemic control (mean reduction in HbA1c 1.0% v 1.1%, p<0.001) than the self managed group.
In patients with suboptimally controlled type 2 diabetes mellitus, insulin glargine titration by a physician was equivalent to titration by the patient for preventing severe hypoglycaemia but inferior to patient titration for glycaemic control.
- Randa Fakhry, RN, MPH
Glycaemic control of type 2 diabetes by novel insulin analogues is promising.1,2 The study by Davies et al was a randomised controlled trial with a large sample size and all drop outs accounted for by the investigators. The multinational and multicentre nature of the study increase the potential for generalisability of the findings. Tight quality control measures were applied, which gives more confidence in the results. High compliance rates were achieved for both algorithms (97.1% and 97.4% used study medications for ⩾22 wks). However, the relatively short follow up period might account for the compliance rates and for the mild to moderate adverse events reported. It is interesting to note that despite the high percentage of patients who had been using insulin for an average of 5 years, HbA1c concentrations were reduced. Baseline demographics did not include literacy level, a variable that could potentially limit the use of algorithm 2 (self management).
The results of this study are relevant to nurse practitioners and nurse specialists working with patients with diabetes, diabetes nurses, and primary care nurses. They clearly indicate that patients with long standing type 2 diabetes from diverse clinical settings can participate in management of their diabetes with glargine. This has the potential for far reaching cost savings for the healthcare system given the increasing prevalence of type 2 diabetes.
For correspondence: Dr M Davies, University Hospitals of Leicester, Leicester, UK.
Source of funding: Sanofi-Aventis.