Dataset Information

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice.

ABSTRACT:

Introduction

Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP).

Methods and analysis

General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking 'does intermittent r-CGM in adults with T2D in primary care improve HbA1c?'

Primary outcome

Absolute difference in mean HbA1c at 12?months follow-up between intervention and control arms.

Secondary outcomes

(a) r-CGM per cent time in target (4-10?mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes).

Eligibility

Aged 18-80 years, T2D for ?1?year, a (past month) HbA1c>5.5?mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four?months). Our general glycaemic target is 53?mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64?mmol/mol (8%)).Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1?hour education by a specialist diabetes nurse.The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5?mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition).

Ethics and dissemination

University of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants.

Trial registration number

>ACTRN12616001372471; Pre-results.

SUBMITTER: Furler J

PROVIDER: S-EPMC6059310 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice.

Furler John J O'Neal David Norman DN Speight Jane J Blackberry Irene I Manski-Nankervis Jo-Anne JA Thuraisingam Sharmala S de La Rue Katie K Ginnivan Louise L Browne Jessica Lea JL Holmes-Truscott Elizabeth E Khunti Kamlesh K Dalziel Kim K Chiang Jason J Audehm Ralph R Kennedy Mark M Clark Malcolm M Jenkins Alicia Josephine AJ Liew Danny D Clarke Philip P Best James J

BMJ open 20180717 7

<h4>Introduction</h4>Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP).<h4>Methods and analysis</h4>General Practice Optimising Structured MOnitoring To achieve Improved C ...[more]

PMID: 30018097

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Project description:ContextThe use of ethnic identifiers in health systems is recommended in several European countries as a means to identify and address heath inequities. There are barriers to implementation that have not been researched.ObjectiveThis study examines whether and how ethnicity data can be collected in Irish general practices in a meaningful and acceptable way.MethodsQualitative case study data generation was informed by Normalization Process Theory (NPT) constructs about 'sense' making and 'engagement'. It consisted of individual interviews and focus group discussions based on visual participatory techniques. There were 70 informants, including 62 general practitioner (GP) users of diverse ethnic backgrounds recruited through community organisations and eight GPs identified through an inter-agency steering group. Data were analysed according to principles of thematic analysis using NPT.ResultsThe link between ethnicity and health was often considered relevant because GP users grasped connections with genetic (skin colour, lactose intolerance), geographic (prevalence of disease, early years exposure), behavioural (culture/food) and social determinant (housing) factors. The link was less clear with religion. There was some scepticism and questions about how the collection of data would benefit GP consultations and concerns regarding confidentiality and the actual uses of these data (e.g. risk of discrimination, social control). For GPs, the main theme discussed was relevance: what added value would it bring to their consultations and was it was their role to collect these data? Their biggest concern was about data protection issues in light of the European Union (EU) General Data Protection Regulation (GDPR). The difficulty in explaining a complex concept such as 'ethnicity' in the limited time available in consultations was also worrying.ConclusionsImplementation of an ethnicity identifier in Irish general practices will require a strong rationale that makes sense to GP users, and specific measures to ensure that its benefits outweigh any potential harm. This is in line with both our participants' views and the EU GDPR.

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Dataset Information

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice.

Introduction

Methods and analysis

Primary outcome

Secondary outcomes

Eligibility

Ethics and dissemination

Trial registration number

Publications

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice.

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