Roche Accu-Chek SmartGuide

CGM Device Guide

Roche Accu-Chek SmartGuide

CE marked in July 2024, the SmartGuide is the newest CGM in this guide. 14-day wear, non-adjunctive from 18 years, and one of the few sensors that offers optional calibration in the first 24 hours.

CGM Roche

Framework status

5 / 5 All five framework criteria met
✓ T1D included – studied in people with type 1 diabetes
✓ Meal challenge included – rapid glucose rises tested, not just stable periods
✓ Hypoglycaemia challenge included – accuracy tested in the low range
✓ Venous blood reference – the gold standard reference method
✓ Population and indication match – adults 18+ (CE mark)

Data sufficiency: Met – ATTD 2024 accuracy study, n=48, 3 sensors per participant (144 sensors total)

Note: 48 participants is at the lower bound of the sufficiency threshold. The study meets criteria but this is acknowledged – additional real-world data will strengthen the evidence base as SmartGuide use grows.

Device at a glance

ManufacturerRoche Diabetes Care
CE markedJuly 2024
UKCA statusUpdated – MHRA confirmed non-adjunctive from 18 years (Clare Leek, Spirit Health / DSNFUK correspondence, May 2025)
Wear duration14 days
Parkes A+B agreement99.8% — comparable to the ±40/40 outer safety band
Outside ±40/40<0.2% of readings (Parkes A+B 99.8% equivalent)
CalibrationOptional calibration in first 24 hours. Factory calibrated thereafter.
ReadingsContinuous – every 5 minutes, via app
UK indicationNon-adjunctive, 18 years and older
AID compatibleNot confirmed – no current UK AID system integration

[Image: Accu-Chek SmartGuide sensor – awaiting editorial image from Roche]

Accuracy

The accuracy figure that matters most clinically is the proportion of readings within safe, actionable bands. For the SmartGuide, 99.8% of readings fall within Parkes error grid zones A and B — the equivalent of the ±40/40 safety band used in the DSNFUK CGM comparison chart. This means fewer than 0.2% of readings fall into a zone where an error could meaningfully affect a dosing decision. The DSNFUK chart, on which this guide is built, uses ±20/20 and ±40/40 agreement rates as primary accuracy measures. MARD — a statistical average — tells you little about what matters clinically and is not used here as a primary measure. ±20/20 data for the SmartGuide is on the DSNFUK chart and will be confirmed from Roche when the peer-reviewed publication is available.

The study was presented at ATTD 2024. A peer-reviewed published paper is anticipated – this page will be updated when the full publication is available.

The black swan – when to trust and when to check

Between 0.5% and 1% of readings from framework-qualified CGMs fall outside the ±40/40 accuracy band. The SmartGuide’s optional first-day calibration is one tool available to reduce the risk of early-wear inaccuracy – when used correctly with a properly performed finger prick. See the accuracy page for the full precautionary framework.

Optional calibration

The SmartGuide is one of the few CGMs in this guide to offer optional calibration. Calibration is available in the first 24 hours of sensor wear and allows the user to enter a finger prick blood glucose reading to refine the sensor’s initialisation.

The DSN Forum UK nursing team noted this positively in GNL Podcast Episode 36: the ability to calibrate in the first 24 hours provides a degree of confidence in a new sensor that factory-only calibrated devices do not offer.

However, calibration only improves accuracy when performed correctly. A calibration based on the CGM reading itself, rather than a proper finger prick, introduces error rather than reducing it. If calibration is used, it requires a clean, dry fingertip, an in-date blood glucose meter with in-date strips, and two measurements averaged before entry.

AID system compatibility

The SmartGuide does not currently integrate with any UK AID system (Omnipod 5, t:slim X2 / Control-IQ, CamAPS FX, or MiniMed 780G). For patients on or considering AID, the device choice is currently driven by AID system compatibility first – see the CGM Guide hub for the AID compatibility overview.

Roche has been contacted for confirmation of any planned AID integration pathway.

Features

Alarms and alerts

Customisable high and low alerts via the Accu-Chek app. Real-time alarm delivery via smartphone. Details of alarm range and customisation options to be confirmed from Roche.

Follow and share

Roche’s sharing functionality details to be confirmed via manufacturer contact. Confirmed functionality will be added here on page update.

App

Accu-Chek app (iOS and Android). Integration with Accu-Chek data management platform for HCP review. App details and screenshots to be confirmed via Roche.

UK context and NHS availability

The SmartGuide is CE marked and UKCA marked, with non-adjunctive indication confirmed for adults 18 years and older. NHS prescribing routes, formulary status, and ICB availability are evolving as the SmartGuide is a recently launched device. Clinical teams should check local formulary status. Roche Diabetes Care UK contacts for clinical enquiries: Sandra Moceri (sandra.moceri@roche.com).

Clinical evidence

  • Roche Diabetes Care (2024). Accu-Chek SmartGuide accuracy data presented at ATTD 2024. MARD 9.2%, Parkes error grid A+B 99.8%. n=48.
  • Peer-reviewed publication in progress. Page updated on publication.

GNL Podcast – coming soon

A GNL Podcast episode with a member of the Roche global medical affairs team is planned as part of the CGM series. This page will be updated with episode content when published.