Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial
Primary result · TIR (blood glucose 3.9–10.0 mmol/l) by CGMResult — go to the resultDifference between the adjusted means 6.5 % 95% CI 3.6%–9.4%Authors' conclusion
The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP.
Study context
- Population
- Adults aged 19–69 years with T1D and HbA1c <85.8 mmol/mol (<10.0%), 13 tertiary medical centres in South Korea; mean age 40±11 yearsrandomised 1:1
- Participants
- 104 adults
- Comparison
- Tubeless, on-body automated insulin delivery (AID) system vs tubeless, on-body sensor-augmented pump (SAP)
- AIDn = 53
- SAPn = 51reference
- Primary endpoint
- Percentage time in range (TIR) (blood glucose 3.9–10.0 mmol/l) measured by CGM
- Follow-up
- 12 weeks
Methodological detailsmulticentre, parallel-group, open-label (blinding not possible), stratified block randomisation
- Multicentre
- Parallel-group
- Open-label (blinding not possible)
- Stratified block randomisation
Primary result
TIR (blood glucose 3.9–10.0 mmol/l) by CGM · over 12 weeks
Difference between the adjusted means
6.5 %
95% CI 3.6%–9.4%
P < 0.001
By group
Interventionvs Control
difference between the adjusted means 6.5 % (95% CI 3.6%–9.4%); P < 0.001
As reported in the abstract
Further findings
TIR at baseline
| Outcome | Intervention | Control | Difference between the adjusted means (mmol/mol) (95% CI) | P value | |
|---|---|---|---|---|---|
| HbA1c · 12 weeks−0.1% [95% CI −0.2%, 0.1%] | mean 45.9 mmol/mol (6.4%) (SD 7.4 mmol/mol (0.7%)) | mean 45.7 mmol/mol (6.3%) (SD 7.5 mmol/mol (0.7%)) | −0.7 (−2.0 to 0.8) | P = 0.366 | |
| −3−2−101Difference, mmol/mol (linear scale) |
| Outcome | Intervention | Control |
|---|---|---|
| HbA1c at baseline | mean 50.9 mmol/mol (6.8%) (SD 9.9 mmol/mol (0.9%)) | mean 48.7 mmol/mol (6.6%) (SD 9.1 mmol/mol (0.8%)) |
Time below range, time above range, CV and mean glucose
- Time below range, time above range, CV and mean glucose levels significantly better with intervention vs control
Safety
- No DKA or severe hypoglycaemia events occurred in either group
Original publication
Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial. Diabetologia. Published 18 April 2024. doi:10.
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