Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial
Authors' conclusion
Stand-alone isCGM offers a greater reduction in HbA1c in adults with type 2 diabetes on MDI when education on the interpretation of graphical patterns in CGM is provided.
Study context
- Population
- Adults with T2D on MDI (intensive insulin therapy) with HbA1c 58–108 mmol/mol (7.5–12.0%); mean baseline HbA1c 68.19±10.94 mmol/mol (8.39±1.00%)148 in full analysis set
- Participants
- 159 adults
- Comparison
- Intermittently scanned continuous glucose monitoring (isCGM) with structured education vs isCGM with conventional education vs blood glucose monitoring (BGM) with conventional education
- Interventionn = 53
- Control 1n = 53reference
- Control 2n = 53reference
- Primary endpoint
- Change in HbA1c from baseline (ANCOVA with baseline value as covariate)
- Follow-up
- 24 weeks
Methodological detailsopen-label, multicentre, 1:1:1 randomisation, block randomisation, Block randomisation by an independent statistician, Blinding of participants and investigators not possible
- Open-label
- Multicentre
- 1:1:1 randomisation
- Block randomisation
- Block randomisation by an independent statistician
- Blinding of participants and investigators not possible
Primary result
As reported in the abstract
Change in HbA1c from baseline
| Group | Value | Change in % |
|---|---|---|
| Intervention | least squares mean change −10.96 (SE 1.35) mmol/mol | −1.00±0.12% |
| Control 1 | least squares mean change −6.87 (SE 1.39) mmol/mol | −0.63±0.13% |
| Control 2 | least squares mean change −6.32 (SE 1.42) mmol/mol | −0.58±0.13% |
Value
Interventionleast squares mean change −10.96 (SE 1.35) mmol/mol
Control 1least squares mean change −6.87 (SE 1.39) mmol/mol
Control 2least squares mean change −6.32 (SE 1.42) mmol/mol
Change in %
Intervention−1.00±0.12%
Control 1−0.63±0.13%
Control 2−0.58±0.13%
- Control 1 vs Intervention: P = 0.0367 vs intervention group
- Control 2 vs Intervention: P = 0.0193 vs intervention group
Safety
Adverse events
Original publication
Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial. Diabetologia. Published 19 April 2024. doi:10. 1007/ s00125-024-06152-1
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