Impact of insulin initiation on glycaemic variability and glucose profiles in a primary healthcare Type 2 diabetes cohort: analysis of continuous glucose monitoring data from the <scp>INITIATION</scp> study

Manski‐Nankervis, Jo‐Anne; Yates, Christopher J; Blackberry, Irene; Furler, John; Ginnivan, Louise; Cohen, Neale; Jenkins, Alicia J.; Vasanthakumar, S.; Gorelik, Alexandra; Young, Doris; Best, James D.; O’Neal, David N

doi:10.1111/dme.12979

Cited by 6 publications

(5 citation statements)

References 27 publications

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“…This first is that people with T2D have relatively stable and simple glucose profiles on a day-to-day basis. 46 This contrasts with people with T1D who have more unpredictable glucose profiles with more GV. Thus, people with T1D need real-time glucose data while people with T2D can learn much about their own glucose profiles and the effects of medication and behaviours from retrospective data, and then use that to effect self-management changes.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2018

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IntroductionOptimal 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 analysisGeneral 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 outcomeAbsolute 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).EligibilityAged 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 disseminationUniversity 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 numberACTRN12616001372471; Pre-results.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2018

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“…Our study was able to follow‐up participants for longer (12 months) and for the first time, to our knowledge, evaluated cost‐effectiveness of professional‐mode flash glucose monitoring used in primary care among a broader population of adults with type 2 diabetes (not just those using insulin). This retrospective mode monitoring, which can be applied intermittently, is particularly appropriate for people with type 2 diabetes, which is characterised by recurring patterns of glycaemia that do not require intensive daily glucose monitoring 7 …”

Section: Discussionmentioning

confidence: 99%

“…This retrospective mode monitoring, which can be applied intermittently, is particularly appropriate for people with type 2 diabetes, which is characterised by recurring patterns of glycaemia that do not require intensive daily glucose monitoring. 7 A major strength of this economic evaluation is that the analysis occurred in the context of a robust RCT with rigorous within-trial efficacy data, which represents the largest RCT of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice. This study also collected health-related quality of life and accurate cost data on the same participants to match the efficacy results, with data linkage near complete (96%).…”

Section: Of 11mentioning

confidence: 99%

“…The professional-mode flash glucose monitoring can be a useful tool for optimising glycaemia in people with type 2 diabetes, whose glucose profiles tend to be reproducible on a day-to-day basis. 7 Currently, there is little evidence about the cost-effectiveness of flash glucose monitoring in type 2 diabetes. One Swedish study reported that realtime flash glucose monitoring was cost-effective compared with traditional self-monitoring of blood glucose in a sample of adults with insulin-treated type 2 diabetes.…”

Section: Introductionmentioning

confidence: 99%

“…The professional‐mode flash glucose monitoring can be a useful tool for optimising glycaemia in people with type 2 diabetes, whose glucose profiles tend to be reproducible on a day‐to‐day basis 7 . Currently, there is little evidence about the cost‐effectiveness of flash glucose monitoring in type 2 diabetes.…”

Section: Introductionmentioning

confidence: 99%

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