For people with non-insulin-treated type 2 diabetes, does a structured approach to self-monitoring of blood glucose improve HbA1c?

Roche Diagnostics Australia0 sites145 target enrollmentAugust 22, 2013

Overview

No summary available.

Registry

who.int

Start Date

August 22, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Roche Diagnostics Australia

•Participants will be eligible to participate if they fulfil the following criteria: Aged 25 years or above; Has had a diagnosis of type 2 diabetes mellitus (T2DM) for 1 year or more prior to study entry; Their T2DM is currently managed with diet and/or oral glucose\-lowering therapies (i.e. not using insulin); Proficient in English (literacy and numeracy); Most recent HbA1c was 7\.5% or above, measured within three months prior to enrolment; Naive to the Accu\-Chek (Registered Trademark) 360 degree View tool but willing to be trained to use the tool; Willing to use Accu\-Chek (Registered Trademark) Performa BG meter; Willing to complete participant questionnaires; Willing to visit the general practice according to the study schedule (four visits across 6 months)

•Participants meeting any of the following criteria will be excluded from the study: Type 1 diabetes, gestational or another diagnosis of diabetes distinct from T2DM; Already using the Accu\-Chek (Registered Trademark) 360 degree View tool; Active proliferative retinopathy, as defined by the application of photocoagulation or surgery, in the six months before study entry or another unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the two years prior to study entry); Women who are pregnant, lactating or planning to become pregnant during the study period; Participants diagnosed with any clinically significant condition (e.g. major organ system disease, infections, psychosis or cognitive impairment); Participants unlikely to follow the study protocol, e.g. inability to return for follow\-up visits; Participant is the investigator or any sub\-investigator, general practitioner, practice staff, pharmacist, research assistant or other staff or relative of those directly involved in the conduct of the study and design of the protocol.