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Efficacy of blood glucose self-monitoring and intensive education in patients with type 2 diabetes not receiving insulin: a pilot study

Efficacy of blood glucose self-monitoring and intensive education in patients with type 2 diabetes not receiving insulin: a pilot study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000389303
Acronym
ROSES
Enrollment
80
Registered
2008-08-04
Start date
2007-10-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with self monitoring blood glucose (SMBG), aimed at lifestyle modification and timely changes in therapy, when needed.

Interventions

self monitoring of blood glucose (SMBG) plus intensive education. SMBG: patients will receive specific educational interventions to teach them how to perform SMBG, how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be provided a glucometer and all the material necessary for SMBG. There will be 2 SMBG educational sessions, the first one

self monitoring of blood glucose (SMBG) plus intensive education. SMBG: patients will receive specific educational interventions to teach them how to perform SMBG, how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be provided a glucometer and all the material necessary for SMBG. There will be 2 SMBG educational sessions, the first one will be at randomization (150 minutes in duration), and the second session after 1 week (20 minutes in duration). Intensive education: patients will be also instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals: weight reduction >=5%, reduction in fat consumption (<30% of daily caloric intake), reduction in saturated fat intake (<10% of daily caloric intake), increase in fiber intake (>=15 gr/1000 Kcal), regular physical activity (>=30 min/daily; >=4 hours/week). The intensive educational sessions will be at the randomization (60 minutes), and after 3 months (60 minutes). The subjects in the intervention group receive both the SMBG and intensive education and standard care too. The educational approach will be standardized and provided by specialist nurses after specific training.

Sponsors

Consorzio Mario Negri Sud
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic; Patients on treatment with oral hypoglycaemic agents (OHA) monotherapy (i.e. metformin alone or sulphonyloureas alone or thiazolidinediones (TZDs) alone); No need for insulin treatment; Male and female patients, aged between 45-75 years; Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value) No experience of self monitoring of blood glucose (SMBG) in the previous 12 months (SMBG performed with a frequency of < 1 times/week) Ability and willingness to comply with all study requirements Signature of consent form

Exclusion criteria

insulin therapy or more than one oral hypoglycaemic agents (OHA); need of self monitoring of blood glucose (SMBG); concomitant serious illnesses causing a reduction of life expectancy; physical or mental problems preventing the self monitoring of blood glucose (SMBG); patient management shared with general practitioner (GP).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026