Structured monitoring of blood glucose for people with non-insulin-treated type 2 diabetes: Structured Testing Program Implementation Trial – Updated Protocol (STeP IT UP)

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus (T2DM); Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12613000927729
• Lead Sponsor: Roche Diagnostics Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 145

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to study end as assessed by a blood pathology test [Baseline and at 3 month and 6 month follow-up]

Secondary Outcome Measures

Name	Time	Method
Diabetes-related distress score as measured by the Diabetes Distress Scale[Baseline and at 3 month and 6 month follow-up];General emotional well-being as measured by the WHO Well-Being Index (WHO-5) scale[Baseline and at 3 month and 6 month follow-up];Diabetes-specific self-efficacy as measured by the Diabetes Empowerment Scale Short Form (DES-SF) [Baseline and at 3 month and 6 month follow-up];Illness perceptions as measured by the Brief Illness Perceptions Questionnaire (BIPQ) scale[Baseline and at 3 month and 6 month follow-up];Attitudes towards self-monitoring of blood glucose as measured by the Self Monitoring Blood Glucose (SMBG) Disinterest Scale [Baseline and at 3 month and 6 month follow-up]