Open-Source Versus Commercial Automated Insulin Delivery System for Type 1 Diabetes Management: A Prospective Observational Comparative Study from Canada
Main finding · 24 h TIR%Result — go to the resultMean difference 7.2 % 95.08% CI 1.9%–12.5%Authors' conclusion
OS-AIDs are safe and noninferior to C-AIDs for TIR% among adults with T1D in real-world settings.
Study context
- Population
- Adults with T1D who had used an automated insulin delivery (AID) system for ≥3 months, Canada
- Participants
- 78 adults
- Exposure
- Open-source AID vs commercial AID
- OS-AIDn = 26
- Commercial-AID (C-AID)n = 52reference
- Outcome
- 24 h TIR% by blinded CGM over 4 weeks; noninferiority margin 5%
- Follow-up
- 4 weeks
Methodological detailsnoninferiority, real-world, 12-week
- Noninferiority
- Real-world
- 12-week
Main finding
24 h TIR%
Mean difference
7.2 %
95.08% CI 1.9%–12.5%
P < 0.001
By group
OS-AIDvs C-AID
mean difference 7.2 % (95.08% CI 1.9%–12.5%); P < 0.001
Non-inferiority margin 5 as printed, not drawn
As reported in the abstract
Observational data: associations, not effects.
Further findings
Patient-reported outcomes
- OS-AID users reported less fear of hypoglycemia; other PRO measures (diabetes distress, hypoglycemia awareness, sleep, treatment satisfaction, overall QoL) not different between groups
Safety
Time in hypoglycaemia (<3.9 mmol/L)
P < 0.001
- Time in hypoglycaemia (<3.9 mmol/L): more time in hypoglycaemia with OS-AID, yet within the recommended range
Severe hypoglycaemia, DKA and technical issues · 12-week study period
- No severe hypoglycemia or DKA was reported in either group
- Similar occurrence rate of technical issues between groups
Original publication
Open-Source Versus Commercial Automated Insulin Delivery System for Type 1 Diabetes Management: A Prospective Observational Comparative Study from Canada. Diabetes Technol Ther. Published 18 March 2025. doi:10. 1089/ dia. 2024. 0561
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