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

Phase 3

Recruiting

• Conditions: non insulin dependent diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12608000389303
• Lead Sponsor: Consorzio Mario Negri Sud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement of metabolic control expressed as HbA1c[at 6 months after randomization]

Secondary Outcome Measures

Name	Time	Method
percentage of patients needing therapy modifications. The protocol describes an algorithm (based on pre prandial glucose levels) that suggests to the investigators when the patient needs therapy modifications.[at six months after randomization];percentage of patients reaching target HbA1c (i.e. <7%)[at six months after randomization];reduction in prandial blood glucose excursion[at six months after randomization]