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

Diabet. Med. 28, 789–796 (2011) 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 random...

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Published in:Diabetic medicine 2011-07, Vol.28 (7), p.789-796
Main Authors: Franciosi, M., Lucisano, G., Pellegrini, F., Cantarello, A., Consoli, A., Cucco, L., Ghidelli, R., Sartore, G., Sciangula, L., Nicolucci, A.
Format: Article
Language:English
Subjects:
Analysis of Variance
Biological and medical sciences
Blood Glucose - metabolism
Blood Glucose Self-Monitoring - economics
Blood Glucose Self-Monitoring - methods
Cost-Benefit Analysis
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - economics
Diabetes. Impaired glucose tolerance
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Etiopathogenesis. Screening. Investigations. Target tissue resistance
Feasibility Studies
Feeding. Feeding behavior
Female
Fundamental and applied biological sciences. Psychology
Glycated Hemoglobin A - analysis
HbA1c
Humans
Hypoglycemic Agents - therapeutic use
Insulin - therapeutic use
Male
Medical sciences
Middle Aged
Patient Education as Topic
Pilot Projects
Quality of Life
randomized controlled trial
self-monitoring of blood glucose
Type 2 diabetes
Vertebrates: anatomy and physiology, studies on body, several organs or systems
Vertebrates: endocrinology
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Summary:Diabet. Med. 28, 789–796 (2011) 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 HbA1c 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 HbA1c value of 7.9% ± 0.6% (63 ± 6 mmol/mol). After 6 months, mean HbA1c 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 HbA1c
ISSN:0742-3071
1464-5491
DOI:10.1111/j.1464-5491.2011.03268.x