Diabetes technology

Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial

DiabetologiaPublished 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
GroupValueChange in %
Interventionleast squares mean change −10.96 (SE 1.35) mmol/mol−1.00±0.12%
Control 1least squares mean change −6.87 (SE 1.39) mmol/mol−0.63±0.13%
Control 2least 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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