Diabetes technology

Open-Source Versus Commercial Automated Insulin Delivery System for Type 1 Diabetes Management: A Prospective Observational Comparative Study from Canada

Diabetes Technol TherPublished Prospective observational comparative study

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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