Diabetes technology

Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study

Diabetes CarePublished Randomised crossover trial

Primary result · Time in range 3.9-10.0 mmol/LResult — go to the resultMean difference 13.2 percentage points 95% CI 9.5–16.9

Authors' conclusion

Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.

Study context

Population
Adults with T1D using insulin pump therapy with suboptimal glycemic control; mean ± SD age 41 ± 12 years, HbA1c 9.2 ± 1.1% [77 ± 12 mmol/mol]
Participants
26 adults
Comparison
Fully closed-loop with ultrarapid insulin lispro (CamAPS HX) vs insulin pump therapy with continuous glucose monitoring (CGM)
Primary endpoint
Proportion of time glucose in range 3.9-10.0 mmol/L
Follow-up
Two 8-week periods
Methodological detailssingle-centre
  • Single-centre

Primary result

Time in range 3.9-10.0 mmol/L

Mean difference

13.2 percentage points

95% CI 9.5–16.9

P < 0.001

By group

Closed-loopvs Pump with CGM
mean difference 13.2 percentage points (95% CI 9.5–16.9); P < 0.001

As reported in the abstract

Further findings

Mean, %

OutcomeClosed-loopPump with CGMMean difference (percentage points) (95% CI)P value
Time with glucose >10.0 mmol/L49.0 (SD 9.9)62.9 (SD 12.6)−13.3 (−17.2 to −9.5)P < 0.001

Mean, mmol/L

OutcomeClosed-loopPump with CGMMean difference (mmol/L) (95% CI)P value
Mean glucose10.7 (SD 1.1)12.0 (SD 1.6)−1.2 (−1.8 to −0.7)P < 0.001

Total daily insulin requirements · did not differ

P = 0.704

Safety

Median

OutcomeClosed-loopPump with CGMP value
Time with glucose <3.9 mmol/LSimilar between periods0.88% (IQR 0.51–1.55)0.64% (IQR 0.28–1.10)P = 0.102

Severe hypoglycemia or DKA

No severe hypoglycemia or ketoacidosis occurred

Original publication

Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study. Diabetes Care. Published 24 August 2023. doi:10.2337/dc23-0728

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