Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE) ABSTRACT ObjeCtive To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. PartiCiPantsAdults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections.interventiOns Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main OutCOMe MeasuresThe primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was −0.85% with pump treatment and −0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was −0.24% (−2.7 mmol/mol) in favour of pump users (95% confidence interval −0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. COnClusiOnsBoth groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined. trial registratiOn Current Controlled Trials ISRCTN61215213.

To improve flexibility and acceptability of diabetic management five patients (age 15-26 years) were changed to NovoPen therapy (Human Actrapid Insulin 3 x daily + Human Ultratard Insulin at night). Diabetic ketoacidosis developed within 2-4 months of commencing this regimen and in one patient twice in only 4 weeks. All failed to increase their insulin dose in response to hyperglycaemia and two patients omitted insulin when they did not take meals believing this to be appropriate irrespective of the prevailing blood glucose. The NovoPen regimen may increase the risk of diabetic ketoacidosis in patients who do not monitor and control their diabetes assiduously and should not be seen as a solution for poorly motivated or ill-educated patients.

We have evaluated a new blood glucose test-strip (Visidex II, Ames), which does not require washing with water after contact with blood. Visidex II showed a significant negative bias when compared with a similar diagnostic strip (BM 20-800, Boehringer) and with the Beckman II glucose analyser (p less than 0.001 in both cases), and a poorer correlation with either method than BM strips with the Beckman II. A significant number (6.3%) of Visidex strips in this study were unreadable due to removal of the colour pads on blotting, and some difficulty was reported by patients in reading values around 6-8 mmol/l. Visidex II can safely be stored in the refrigerator and developed strips may be stable longer than BM strips. A significant error in reading was noted if the incubation time was varied by +/- 5 seconds. Further experience and perhaps some modifications may be necessary before Visidex II can be recommended for widespread use.