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Trial registered on ANZCTR


Registration number
ACTRN12613000927729
Ethics application status
Approved
Date submitted
12/07/2013
Date registered
22/08/2013
Date last updated
8/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Structured monitoring of blood glucose for people with non-insulin-treated type 2 diabetes: Structured Testing Program Implementation Trial – Updated Protocol (STeP IT UP)
Scientific title
For people with non-insulin-treated type 2 diabetes, does a structured approach to self-monitoring of blood glucose improve HbA1c?
Secondary ID [1] 282796 0
nil
Universal Trial Number (UTN)
Trial acronym
STeP IT UP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus (T2DM) 289564 0
Condition category
Condition code
Metabolic and Endocrine 289892 289892 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287476 0
Behaviour
Comparator / control treatment
No Comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289952 0
Change in HbA1c from baseline to study end as assessed by a blood pathology test
Timepoint [1] 289952 0
Baseline and at 3 month and 6 month follow-up
Secondary outcome [1] 303647 0
Diabetes-related distress score as measured by the Diabetes Distress Scale
Timepoint [1] 303647 0
Baseline and at 3 month and 6 month follow-up
Secondary outcome [2] 303648 0
General emotional well-being as measured by the WHO Well-Being Index (WHO-5) scale
Timepoint [2] 303648 0
Baseline and at 3 month and 6 month follow-up
Secondary outcome [3] 303649 0
Diabetes-specific self-efficacy as measured by the Diabetes Empowerment Scale Short Form (DES-SF)
Timepoint [3] 303649 0
Baseline and at 3 month and 6 month follow-up
Secondary outcome [4] 303650 0
Illness perceptions as measured by the Brief Illness Perceptions Questionnaire (BIPQ) scale
Timepoint [4] 303650 0
Baseline and at 3 month and 6 month follow-up
Secondary outcome [5] 303651 0
Attitudes towards self-monitoring of blood glucose as measured by the Self Monitoring Blood Glucose (SMBG) Disinterest Scale
Timepoint [5] 303651 0
Baseline and at 3 month and 6 month follow-up

Eligibility
Key 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)
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome variable of interest in this study is change in HbA1c from baseline to follow-up. In the original STeP study (clinical trial NCT00674986) standard errors (SEs) of 0.09% and 0.10% were reported for HbA1c reductions from baseline to study end for the intervention and control groups. The study groups consisted of 256 and 227 participants for intention to treat analysis. This leads to standard deviations (SDs) for the HbA1c changes of about 1.5%. Using a one-group (paired) t-test (two-sided, p=0.05), a sample size of 97 will have 90% power to detect a mean HbA1c decrease from baseline to study end of at least 0.5%, assuming a SD of differences of 1.5%. To account for a possible 33% attrition rate, approximately 145 adults with T2DM will be required for this study.

Two approaches will be taken to the analysis of change in HbA1c and other outcomes. First, an intention to treat (ITT) analysis will be performed, defined as eligible participants who took part in Visit 1 (screening) and Visit 2 (first data download and acquisition). Second, a per protocol (PP) analysis will be undertaken, defined as all participants of the ITT population who completed all scheduled visits without any major protocol deviations. As in the original STeP study, to be included in the PP analysis, participants must have completed at least 80% of the blood glucose measurements on the 360 degree View tool, brought their completed tool to each GP visit, and reported that their GPs looked at the tool and discussed the results.
The absolute and relative change in HbA1c (i.e. HbA1c change divided by the baseline HbA1c) will be evaluated using a two-sided one-sample t-test, and by using analysis of covariance with the covariables such as gender, baseline HbA1c, diabetes duration, and age. Similar analyses will be conducted for psychosocial outcomes and other clinical outcomes of interest. Subgroup analyses may be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2012
Actual
17/07/2012
Date of last participant enrolment
Anticipated
27/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
145
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 287568 0
Commercial sector/Industry
Name [1] 287568 0
Roche Diagnostics Australia
Country [1] 287568 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Roche Diagnostics Australia
Address
Head Office:
31 Victoria Avenue
Castle Hill NSW 2154
Country
Australia
Secondary sponsor category [1] 286339 0
None
Name [1] 286339 0
Address [1] 286339 0
Country [1] 286339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289546 0
Faculty of Health Human Ethics Advisory Group at Deakin University
Ethics committee address [1] 289546 0
Secretary HEAG-H
Pro Vice-Chancellor's Office
Faculty of Health
he3.018
221 Burwood Hwy
Burwood VIC 3125
Ethics committee country [1] 289546 0
Australia
Date submitted for ethics approval [1] 289546 0
Approval date [1] 289546 0
27/01/2012
Ethics approval number [1] 289546 0
reference number: HEAG-H 162_2012

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41270 0
Prof Jane Speight
Address 41270 0
The Australian Centre for Behavioural Research in Diabetes
Diabetes Australia – Vic
570 Elizabeth St
Melbourne 3000
VIC
Country 41270 0
Australia
Phone 41270 0
+61 3 86481850
Fax 41270 0
Email 41270 0
JSpeight@acbrd.org.au
Contact person for public queries
Name 41271 0
Dr George Koumantakis
Address 41271 0
Roche Diagnostics Australia
31 Victoria Avenue
Castle Hill, NSW 2154 Australia
Country 41271 0
Australia
Phone 41271 0
+61 (2) 8665 9922
Fax 41271 0
Email 41271 0
george.koumantakis@roche.com
Contact person for scientific queries
Name 41272 0
Prof Jane Speight
Address 41272 0
The Australian Centre for Behavioural Research in Diabetes
Diabetes Australia – Vic
570 Elizabeth St
Melbourne 3000
VIC
Country 41272 0
Australia
Phone 41272 0
+61 3 86481845
Fax 41272 0
Email 41272 0
jspeight@acbrd.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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