Diabetes technology

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes

Diabetes Technol TherPublished Single-arm multicentre trial

Authors' conclusion

URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants.

Study context

Population
Children, adolescents and adults with T1D (age 6–75 years), 14 U.S. diabetes centers
Participants
179 children
Comparison
URLi vs lispro in Control-IQ 1.5 pump
Outcome
Safety of URLi in t:slim X2 pump with Control-IQ 1.5
Follow-up
13 weeks
Methodological details16-day lead-in with lispro, 13-week URLi period
  • 16-day lead-in with lispro
  • 13-week URLi period

Main finding

As reported in the abstract

Safety

Severe hypoglycemia with URLi, attributed to override boluses or a missed meal

1.7%

3 participants

DKA events

0

Stopped URLi due to infusion-site discomfort

2 participants

Stopped URLi after developing a rash

1 participant

Further findings

OutcomeMean difference (95% CI)P value
Insulin treatment satisfaction questionnaire score · screening to 13 weeks of URLiURLi (13 weeks)vs Screening6 (4–8)P < 0.001
OutcomeURLiLisproP value
TIR 70-180 mg/dLIncreased with URLimean 67% ± 13%mean 65% ± 15%P = 0.004
  • Insulin treatment satisfaction questionnaire score: improved from 75 ± 13 to 80 ± 11; greatest improvement for confidence avoiding symptoms of high blood sugar

TRIM-Diabetes score

Mean score improved from 74 ± 12 to 80 ± 12
P < 0.001

TRIM-Diabetes Device score

Mean score improved from 82 ± 11 to 86 ± 12
P < 0.001

Safety

Adverse events with URLi · 13 weeks

Severe hypoglycemia
1.7% (3 participants)
DKA events
0
Stopped URLi: infusion-site discomfort
2
Stopped URLi: rash
1

Original publication

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. Published 22 May 2024. doi:10.1089/dia.2024.0048

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