Efficacy and Safety of a Tubeless Automated Insulin Delivery (AID) System Compared With Pump Therapy With Continuous Glucose Monitor (CGM) in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial
Primary result · TIR (70-180 mg/dL)Result — go to the resultMean difference 17.5 % 95% CI 14.0%–21.1%Authors' conclusion
Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGM among adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population.
Study context
- Population
- Adults aged 18–70 years with T1D and HbA1c 7–11% (53–97 mmol/mol), U.S. and Francerandomized 2:1
- Participants
- 194 adults
- Comparison
- Tubeless AID vs pump therapy with CGM
- Interventionn = 132
- Controln = 62reference
- Primary endpoint
- Time in range (TIR) (70-180 mg/dL) during the trial period
- Follow-up
- 13 weeks
Methodological detailsmulticenter, parallel-group, 13-week, randomized 2:1
- Multicenter
- Parallel-group
- 13-week
- Randomized 2:1
Primary result
TIR (70-180 mg/dL) · during the trial
Mean difference
17.5 %
95% CI 14.0%–21.1%
P < 0.0001
Interventionvs Control
mean difference 17.5 % (95% CI 14.0%–21.1%); P < 0.0001
As reported in the abstract
Secondary outcomes
Time <70 mg/dL
P = 0.005
Time >180 mg/dL
P < 0.0001
| Outcome | Intervention | Control | P value |
|---|---|---|---|
| Change in HbA1c from baselineGreater reduction with intervention · mean, % | −1.24 (SD 0.75) | −0.68 (SD 0.93) | P < 0.0001 |
| Mmol/mol | −13.6 ± 8.2 | −7.4 ± 10.2 |
All primary and secondary outcomes
- All primary and secondary outcomes were met
Safety
Time <70 mg/dL · 13 weeks · significantly lower with intervention
P = 0.005
DKA or severe hypoglycaemia · 13 weeks
- No instances of DKA or severe hypoglycaemia in the intervention group
Original publication
Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial. Diabetes Care. Published 18 October 2024. doi:10.
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