Safety and Efficacy of Sustained Automated Insulin Delivery Compared With Sensor and Pump Therapy in Adults With Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial
Primary result · TBR change from baselineResult — go to the resultDifference −3.7 % 95% CI −4.8 to −2.6Authors' conclusion
In adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than twofold, as quantified by TBR, while improving TIR and reducing hyperglycemia. Hence, AID is strongly recommended for this specific population.
Study context
- Population
- Adults with T1D using an insulin pump, at high risk for hypoglycemia (Clarke score >3 and/or severe hypoglycemia in previous 6 months), with time below range (TBR) (<70 mg/dL) ≥5% on 2 weeks of blinded continuous glucose monitoring (CGM)
- Participants
- 72 adults
- Comparison
- Automated insulin delivery (AID) vs CGM and pump therapy
- Primary endpoint
- TBR change from baseline
- Follow-up
- 12 weeks
Methodological detailsparallel-arm, randomized 2:1, Optional 12-week AID extension offered to all participants
- Parallel-arm
- Randomized 2:1
- Optional 12-week AID extension offered to all participants
Primary result
As reported in the abstract
Difference
−3.7 %
95% CI −4.8 to −2.6
P < 0.001
AIDvs S&P
difference −3.7 % (95% CI −4.8 to −2.6); P < 0.001
Secondary outcomes
| Outcome | Estimate | P value | |
|---|---|---|---|
| TIR (70-180 mg/dL) · 12 weeks | increase 8.6 % (95% CI 5.2–12.1) | P < 0.001 | |
| TAR · 12 weeks | decrease −5.3 % (95% CI −87.7 to −1.8) | P = 0.004 | |
| −100−50050Difference, % (linear scale) |
Mean SG reading · 12 weeks
- Mean SG reading remained similar in the AID and S&P groups
12-week AID extension
- Effects of AID sustained in the AID group and reproduced in the S&P group
Safety
- Severe hypoglycemic episodes — AID
- 2 events
Original publication
Safety and Efficacy of Sustained Automated Insulin Delivery Compared With Sensor and Pump Therapy in Adults With Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial. Diabetes Care. Published 20 September 2023. doi:10.
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