Clinical evidence for high‐risk CE ‐marked medical devices for glucose management: A systematic review and meta‐analysis
Pooled result · HbA1c (RCT meta-analysis)Result — go to the resultAbsolute MD −0.5 percentage pointsAuthors' conclusion
High-risk devices for glucose monitoring or insulin dosing, in particular AID systems, improve glucose control safely, but evidence on diabetes-related end-organ damage is lacking due to short study durations. Methodological heterogeneity highlights the need for developing standards for future pre- and post-market investigations of diabetes-specific high-risk medical devices.
Study context
- Population
- Studies of CE-marked high-risk devices for glucose management: Automated insulin delivery (AID) systems, implantable insulin pumps and implantable continuous glucose monitoring (CGM) devices (2009–2024)182 studies
- Comparison
- AID systems vs other treatments
- Outcome
- HbA1c (RCT meta-analysis)
Methodological detailsCoordinating Research and Evidence for Medical Devices (CORE-MD) project, interventional and observational studies, meta-analysis of randomized controlled trials (RCTs)
- CORE-MD project
- Interventional and observational studies
- Meta-analysis of RCTs
Pooled result
As reported in the abstract
Absolute MD
−0.5 percentage points
Further pooled results
| Outcome | MD (percentage points) |
|---|---|
| TIR for sensor glucose14 RCTs; I2 = 90% | 13.4 |
Included study characteristics
- Studies on AID systems
- 166
- Studies on insulin pumps
- six
- Studies on CGM devices
- 10
- RCTs
- 29%
- Non-randomized trials
- 24%
- Observational studies
- 47%
- Pre-market
- 18%
- Had a comparator group
- 37%
- Median (IQR) sample size
- 48 (28-102)
- Median (IQR) age, years
- 34.8 (14-44.2)
- Median (IQR) study duration, weeks
- 17.5 (12-26)
Safety
Safety assessment
- Studies assessing at least one safety outcome
- 71%
Original publication
Clinical evidence for high‐risk CE ‐marked medical devices for glucose management: A systematic review and meta‐analysis. Diabetes Obes Metab. Published 14 August 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →