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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.
Diabet Med 2011; 28(7):789-96DM

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.

Authors+Show Affiliations

Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21342243

Citation

Franciosi, M, et al. "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." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 28, no. 7, 2011, pp. 789-96.
Franciosi M, Lucisano G, Pellegrini F, et al. 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. 2011;28(7):789-96.
Franciosi, M., Lucisano, G., Pellegrini, F., Cantarello, A., Consoli, A., Cucco, L., ... Nicolucci, A. (2011). 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. Diabetic Medicine : a Journal of the British Diabetic Association, 28(7), pp. 789-96. doi:10.1111/j.1464-5491.2011.03268.x.
Franciosi M, et al. 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. 2011;28(7):789-96. PubMed PMID: 21342243.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Franciosi,M, AU - Lucisano,G, AU - Pellegrini,F, AU - Cantarello,A, AU - Consoli,A, AU - Cucco,L, AU - Ghidelli,R, AU - Sartore,G, AU - Sciangula,L, AU - Nicolucci,A, AU - ,, PY - 2011/2/24/entrez PY - 2011/2/24/pubmed PY - 2011/9/15/medline SP - 789 EP - 96 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 28 IS - 7 N2 - 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. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/21342243/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_ L2 - https://doi.org/10.1111/j.1464-5491.2011.03268.x DB - PRIME DP - Unbound Medicine ER -