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ROSES: role of self‐monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial
Author(s) -
Franciosi M.,
Lucisano G.,
Pellegrini F.,
Cantarello A.,
Consoli A.,
Cucco L.,
Ghidelli R.,
Sartore G.,
Sciangula L.,
Nicolucci A.
Publication year - 2011
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2011.03268.x
Subject(s) - medicine , diabetes mellitus , randomized controlled trial , type 2 diabetes , clinical endpoint , insulin , metabolic control analysis , gastroenterology , endocrinology
Diabet. Med. 28, 789–796 (2011) Abstract Aims To estimate the efficacy of a self‐monitoring‐based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy. Methods This was an open‐label, randomized, pilot study, primarily led by diabetes nurses. Patients were randomly allocated to either a self‐monitoring‐based disease management strategy or usual care (ratio 3:1) and followed up for 6 months. Education was centred on how to modify lifestyle according self‐monitoring readings. Self‐monitoring of blood glucose results were discussed during monthly telephone contact. The primary endpoint was mean change in HbA 1c levels, estimated with an ANOVA for repeated measures. All analyses were intention to treat. Results Three diabetic clinics recruited 62 patients, of whom five were lost to follow‐up. At baseline, both groups had a mean HbA 1c value of 7.9% ± 0.6% (63 ± 6 mmol/mol). After 6 months, mean HbA 1c reduction was 1.2 ± 0.1% (–13 ± 1 mmol/mol) in the intervention group and 0.7 ± 0.2 (–8 ± 2 mmol/mol) in the control group, with an absolute mean difference between groups of –0.5% (95% CI −0.9 to −0.0%; P = 0.04) (−5 mmol/mol, 95% CI −10 to 0). At study end, 61.9% of patients in the intervention group and 20.0% in the control group reached the target level of HbA 1c < 7.0% (< 53 mmol/mol) ( P = 0.005). Body weight reduction was significantly greater in the intervention group than in the control group (between‐group absolute mean difference: −3.99 kg; 95% CI −7.26 to −0.73; P = 0.02). Therapy changes were more frequent in the control group. Conclusions A self‐monitoring disease management strategy, primarily led by diabetes nurses and allowing a timely and efficient use of self‐monitoring readings, is able to improve metabolic control, primarily through lifestyle modifications leading to weight loss.