None listed
Conditions
Brief summary
This study (STeP IT UP) aims to examine the effectiveness of a structured approach to self-monitoring of blood glucose (SMBG) for adults with non-insulin-treated T2DM in an Australian primary care (general practice) setting, with a focus on the clinical utility of structured SMBG in this group. The STeP IT UP study also aims to build on the available evidence from the original STeP study by refining the structured SMBG training provided to participants with use of DVD training resources to ensure a sustainable approach, and by optimising psychosocial outcome measures used. It is hypothesised that the findings from STeP IT UP will demonstrate to healthcare professionals (especially those working in primary care) that (a) structured SMBG, when embedded in care and performed in the context of education and support, has clinical benefits, and (b) that it is feasible for doctors and their patients to develop the necessary knowledge and skills to conduct SMBG in an effective manner. Key resources to be used in STeP IT UP (e.g. educational DVD for participants) can be made freely available on the internet, and so sustained implementation of this structured SMBG intervention is possible beyond the life of the study. We, therefore, anticipate that the findings of the STeP IT UP study will have the potential to influence the approach to SMBG in Australian primary care for people with T2DM who do not use insulin, such that effective approaches to SMBG are recommended and adopted.
Interventions
STeP IT UP is a six month, multi-site study of a comprehensive doctor/patient intervention that uses a highly structured and systematic self monitoring of blood glucose (SMBG) regimen for the purposes of optimising blood glucose management.
Using the Accu-Chek (Registered Trademark) 360 degree View tool, participants will create a 7-point (pre- and post-prandial for each meal, and before bed at night) blood glucose profile on three consecutive days in the week prior to a consultation with their
STeP IT UP is a six month, multi-site study of a comprehensive doctor/patient intervention that uses a highly structured and systematic self monitoring of blood glucose (SMBG) regimen for the purposes of optimising blood glucose management. Using the Accu-Chek (Registered Trademark) 360 degree View tool, participants will create a 7-point (pre- and post-prandial for each meal, and before bed at night) blood glucose profile on three consecutive days in the week prior to a consultation with their general practitioner (GP). This simple tool allows participants to record their blood glucose level and then plot their blood glucose profile over the three days. It enables recognition of problematic blood glucose excursions (e.g. after a large breakfast), and identification of activities that lower blood glucose levels (e.g. physical activity). The tool also allows participants to record their medication-taking, meal sizes, and activity levels on the days that they perform SMBG so that there is adequate context for the interpretation of the blood glucose profiles by participants and their GPs. Throughout the course of the study, all participants will be requested to attend four visits to the general practice clinic over a 6-month period: Visits 1 (week 0), 2 (week 4), 3 (week 12), and 4 (week 24). The 360 degree view tool will be completed on three consecutive days in the week prior to visits 2, 3 and 4. The GP will work with the patient to educate them about structured monitoring and use of the tool and ensure the patient has sufficient knowledge to adhere to the SMBG protocol (visits 1 and 2; patients will also be given an educational DVD during visit 1), and to interpret blood glucose patterns and problem-solve on the basis of the available data (visits 2 - 4). SMBG data will be uploaded by the GP onto a secure server and the data will be viewed and discussed collaboratively during visits 2 - 4. In this way, the intervention is a highly collaborative approach to using SMBG in primary practice. In sum, the intervention period is 6 months long, and the participants will complete the 360 degree view tool at least nine times during this period (three consecutive days in the week prior to visits 2, 3 and 4). It is only these data that will be used for study purposes, however participants are free to use the tool on additional days if they wish.
Sponsors
Roche Diagnostics Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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.
Outcome results
None listed